Find a Clinical Trial in Hairy Cell Leukemia (HCL) or HCLv
This page brings together studies for people with hairy cell leukemia (HCL) and HCL variant (HCLv). You will find clinical trials that are actively recruiting patients, organized by treatment type, treatment history, and HCL subtype to help you identify options that may be relevant to your situation. You will also find research participation opportunities and resources to help you discuss options with your healthcare team.
Clinical Trials Actively Recruiting Patients
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Following these steps will help you easily explore all available trials.
Clinical Trials by Treatment Type
Clinical Trials by Treatment History
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These clinical trials do not use chemotherapy, such as cladribine or pentostatin. Instead, they focus on treatments like Vemurafenib, Binimetinib, Rituximab, and newer options such as CAR-T cell therapy.
Venetoclax for People With Relapsed HCL
Learn more about this trial (link to trial here)
What is the primary objective of this clinical trial?
To determine the objective response rate (ORR) of venetoclax in patients with HCL that has returned after improvement.
Venetoclax belongs to a group of drugs called B-cell lymphoma-2 (BCL-2) inhibitors. It stops cancer cells from growing by blocking BCL-2, a protein that cancer cells need to survive. Venetoclax comes in a tablet form.
ORR is the percentage of people in a study who have a partial or complete response to treatment within a certain period. A partial response is a decrease in tumor size or cancer amount, and a complete response is the disappearance of all cancer signs. Measuring ORR in a clinical trial shows how well a new treatment works.
You may be able to join this trial if you:
Have relapsed hairy cell leukemia (HCL) or relapsed HCL variant (HCLv)
Have previously received purine analog treatment
Were treated using BRAF inhibitors, but relapsed, or are ineligible for BRAF inhibitors
Have not previously been treated with venetoclax
Need treatment because your disease is active
Meet the study’s other lab and health requirements
Who to contact about this trial:
This study has 21 locations, including sites in California, Florida, Kansas, Missouri, and Maryland.
Robert J Kreitman from the NCI is the Principal Investigator.
Phone: 800-411-1222
…
Binimetinib as a treatment for people with relapsed or refractory BRAF wild-type hairy cell leukemia (HCL) and HCL variant (HCLv)
Learn more about this trial. (link to trial here)
What is the primary objective of this clinical trial?
To see if binimetinib is an effective treatment for people with HCL that does not have a BRAF mutation.
Most people with HCL have a BRAF gene mutation. They can be treated with BRAF inhibitors, drugs that target this mutation. For people who do not have this mutation, BRAF inhibitors are not a treatment option. The researchers found that when HCL does not have the BRAF mutation, the MEK gene is frequently mutated. Binimetinib targets MEK.
You may be able to join this trial if you:
Have BRAF wild-type HCL or HCLv
Do not have the BRAF mutation
Have received at least one prior treatment with a purine analog, such as cladribine or pentostatin
Need treatment, as shown by blood counts or an enlarged spleen
Do not have an uncontrolled infection, heart or lung problems, or another cancer that needs treatment
Have not received any treatment in the 4 weeks before the study begins
Meet the study’s other lab and health requirements.
Who to contact about this trial:
Holly M Eager, R.N.; (240) 858-7229; holly.eager@nih.gov
…
Phase I Study of Anti-CD22 CAR T-Cell Therapy for Patients with Relapsed or Refractory Hairy Cell Leukemia (HCL) and HCL Variant (HCLv)
Learn more about this trial. (link to trial here)
What is the primary objective of this clinical trial?
To see if anti-CD22 CAR T-cells are safe and effective for people with HCL or HCLv after they have received a treatment regimen of cyclophosphamide and fludarabine.
CAR (Chimeric Antigen Receptor) T-cell therapy is a type of cancer treatment in which a person’s T cells (a type of immune cell) are changed in a laboratory to recognize and attack cancer cells.
You may be able to join this trial if you:
Have HCL or HCLv
Have previously received treatment with or been ineligible for: 1) Chemotherapy combined with Rituximab, 2) moxetumomab pasudotox, and/or 3) a BRAF inhibitor such as Vemurafenib.
Need treatment
Meet the study’s other lab and health requirements.
Who to contact about this trial:
This study has one location.
National Institutes of Health
Olena Sierra: (240) 858-3185 or olena.sierraortiz@nih.gov
…
Encorafenib Plus Binimetinib for People With BRAF V600 Mutated Relapsed/Refractory HCL
Learn more about this trial. (link to trial here)
What is the primary objective of this clinical trial?
To test whether treating BRAF-positive HCL with both encorafenib and binimetinib works better than vemurafenib alone.
Encorafenib is a medicine often given with other drugs, like binimetinib, to treat some cancers. It works by blocking proteins made by the mutated BRAF gene. It comes in a capsule form.
Binimetinib is a medicine that blocks proteins called MEK1 and MEK2. It comes in a tablet form.
You may be able to join this trial if you:
Have BRAF-positive HCL that did not respond to treatment or has returned after treatment
Have had at least one previous purine analog treatment, such as cladribine or pentostatin
Need treatment
Meet the study’s other lab and health requirements.
Who to contact about this trial:
This study has one location.
Dr. Robert J. Kreitman
kreitmar@mail.nih.gov or 301-648-7375
Holly M Eager, R.N.
holly.eager@nih.gov or (240) 858-7229
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A randomized clinical trial is a study in which participants are assigned randomly to different treatment groups to compare outcomes.
Vemurafenib plus Obinutuzumab Vs. Cladribine plus Rituximab in Previously Untreated HCL
Learn more about this trial. (link to trial here)
View the webinar about this study.>>
What is the primary objective of this clinical trial?
Study the safety of vemurafenib in combination with obinutuzumab compared to the standard approach of cladribine in combination with rituximab.
The researchers will examine which treatment causes fewer or milder side effects and which approach is more effective at eliminating cancer cells.
Vemurafenib is a drug that blocks proteins produced by the BRAF V600E mutation.
Obinutuzumab is a medicine used in combination with other drugs to treat certain types of cancer. Obinutuzumab binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of leukemia and lymphoma cells. Obinutuzumab blocks CD20 and helps the immune system kill cancer cells. It is a type of monoclonal antibody.
Patients enrolling in this trial will receive one of two treatment options, both of which are effective in treating classic BRAF-positive HCL. No placebo is involved in this trial.
You may be able to join this trial if you:
Have HCL
Have the BRAF V600E mutation; if unsure, repeat BRAF testing.
Have not received any prior therapy for HCL
Need treatment
Meet the study’s other lab and health requirements.
Who to contact about this trial:
Jae Park, MD Email: parkj6@mskcc.org
Study back-up contact: Mark Geyer, MD Phone Number: 646-608-3745
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Chemotherapy for HCL uses drugs called purine analogs, like Cladribine and Pentostatin.
Cladribine and Rituximab in Treating Patients with Hairy Cell Leukemia
Learn more about this trial. (link to trial here)
What are the primary objectives of this clinical trial?
To study the combination of cladribine followed by rituximab in people with HCL, and
Determine how effective this approach is at achieving complete remission, eliminating minimal residual disease (MRD), and improving long-term outcomes.
You may be able to join this trial if you have:
Have HCL
If relapsed, have had no more than one prior treatment
Meet the study’s other lab and health requirements.
Who to contact about this trial:
Farhad Ravandi, MD
Phone: 713-792-7305 or Email: fravandi@mdanderson.org
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Vemurafenib plus Obinutuzumab Vs. Cladribine plus Rituximab in Previously Untreated HCL
Learn more about this clinical trial. (link to trial here)
View the webinar about this study.>>
What is the primary objective of this clinical trial?
Study the safety of vemurafenib in combination with obinutuzumab compared to the standard approach of cladribine in combination with rituximab.
The researchers will examine which treatment causes fewer or milder side effects and which approach is more effective at eliminating cancer cells.
Vemurafenib is a drug that blocks proteins produced by the BRAF V600E mutation.
Obinutuzumab is a medicine used in combination with other drugs to treat certain types of cancer. Obinutuzumab binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of leukemia and lymphoma cells. Obinutuzumab blocks CD20 and helps the immune system kill cancer cells. It is a type of monoclonal antibody.
You may be able to join this trial if you:
Have HCL
Have the BRAF V600E mutation; if unsure, repeat BRAF testing.
Have not received any prior therapy for HCL
Need treatment
Meet the study’s other lab and health requirements.
Who to contact about this trial:
Jae Park, MD Email: parkj6@mskcc.org
Study back-up contact: Mark Geyer, MD Phone Number: 646-608-3745
…
Cladribine and Rituximab in Treating Patients with Hairy Cell Leukemia
Learn more about this trial. (link to trial here)
What are the primary objectives of this clinical trial?
To study the combination of cladribine followed by rituximab in people with HCL, and
Determine how effective this approach is at achieving complete remission, eliminating minimal residual disease (MRD), and improving long-term outcomes.
You may be able to join this trial if you:
Have HCL
If relapsed, have had no more than one prior treatment
Who to contact about this trial:
Farhad Ravandi, MD
Phone: 713-792-7305 or Email: fravandi@mdanderson.org
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Venetoclax for People With Relapsed HCL
Learn more about this trial (link to trial here)
What is the primary objective of this clinical trial?
To determine the objective response rate (ORR) of venetoclax in patients with HCL that has returned after improvement.
Venetoclax belongs to a group of drugs called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop cancer cells from growing by blocking BCL-2, a protein that cancer cells need to survive.
ORR is the percentage of people in a study who have a partial or complete response to treatment within a certain period. A partial response is a decrease in tumor size or cancer amount, and a complete response is the disappearance of all cancer signs. Measuring ORR in a clinical trial shows how well a new treatment works.
You may be able to take part in this trial if you:
Have relapsed hairy cell leukemia (HCL) or relapsed HCL variant (HCLv)
Have previously received purine analog treatment
Were treated using BRAF inhibitors, but relapsed, or are ineligible for BRAF inhibitors
Have not previously been treated with venetoclax
Need treatment because your disease is active
Meet the study’s other lab and health requirements
Who to contact about this trial:
This study has 21 locations, including sites in California, Florida, Kansas, Missouri, and Maryland.
Robert J Kreitman from the NCI is the Principal Investigator.
Phone: 800-411-1222
…
Tovorafenib + rituximab in recurrent/refractory classic HCL and comparing with cladribine + rituximab in untreated classic HCL.
Learn more about this trial. (link to trial here)
What are the primary objectives of this clinical trial?
To evaluate the safety and tolerability of tovorafenib plus rituximab in patients with relapsed or refractory HCL, and
To determine the MRD-negative complete remission rate of tovorafenib plus rituximab compared to cladribine plus rituximab for untreated HCL.
Tovorafenib is a drug used to treat pediatric cancer that is being studied in other types of cancer, including HCL. Tovorafenib blocks certain proteins made by the mutated BRAF gene.
Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some cancer cells.
You may be able to join this trial if you:
Have BRAF-positive HCL
Have had prior therapy with at least one purine analog (fludarabine, pentostatin, or cladribine) unless you are ineligible.
Need treatment
Meet the study’s other lab and health requirements.
Who to contact about this trial:
This study has 4 locations, including sites in Maryland, Ohio, Pennsylvania, and Virginia.
The principal investigator for this trial is Seema A. Bhat, The Ohio State University Comprehensive Cancer Center.
Phone number: 800-293-5066
Email address: Jamesline@osumc.edu
…
Phase I Study of Anti-CD22 CAR T-Cell Therapy for Patients with Relapsed or Refractory Hairy Cell Leukemia (HCL) And HCL Variant (HCLv)
Learn more about this trial. (link to trial here)
What is the primary objective of this clinical trial?
To see if anti-CD22 CAR T-cells are safe and effective for people with HCL or HCLv after they have received a treatment regimen of cyclophosphamide and fludarabine.
CAR (Chimeric Antigen Receptor) T-cell therapy is a type of cancer treatment in which a person’s T cells (a type of immune cell) are changed in a laboratory to recognize and attack cancer cells.
You may be able to join this trial if you:
Have HCL or HCLv
Have previously received treatment or been ineligible for: 1) Chemotherapy combined with Rituximab, 2) moxetumomab pasudotox, and/or 3) a BRAF inhibitor such as Vemurafenib.
Need treatment
Meet the study’s other lab and health requirements.
Who to contact about this trial:
This study has one location.
Olena Sierra: (240) 858-3185 or olena.sierraortiz@nih.gov
…
Encorafenib plus Binimetinib is being studied for people with BRAF V600E-mutated relapsed or refractory Hairy Cell Leukemia (HCL).
Learn more about this trial. (link to trial here)
What is the primary objective of this clinical trial?
This trial is testing whether treating BRAF-positive HCL with both encorafenib and binimetinib works better than vemurafenib alone.
Encorafenib is a medicine often given with other drugs, like binimetinib, to treat some cancers. It works by blocking proteins made by the mutated BRAF gene. It comes in a capsule form.
Binimetinib is a medicine that blocks proteins called MEK1 and MEK2. It comes in a tablet form.
You may be able to join this trial if you:
Have BRAF-positive HCL that did not respond to treatment or has returned after treatment
Have had at least one previous purine analog treatment, such as cladribine or pentostatin
Currently need treatment
Do not have an uncontrolled infection, serious heart or lung problems, or another cancer that also needs treatment
Have not received any treatment in the four weeks before the study starts
Who to contact about this trial:
This study has one location.
Dr. Robert J. Kreitman
kreitmar@mail.nih.gov or 301-648-7375
Holly M Eager, R.N.
holly.eager@nih.gov or (240) 858-7229
…
Binimetinib for people with relapsed/refractory BRAF Wild Type HCL and Variant
Learn more about this trial. (link to trial here)
What is the primary objective of this clinical trial?
To see if binimetinib is an effective treatment for people with HCL that does not have a BRAF mutation.
Most people with HCL have a BRAF gene mutation. They can be treated with BRAF inhibitors, drugs that target this mutation. For people who do not have this mutation, BRAF inhibitors are not a treatment option. The researchers found that when HCL does not have the BRAF mutation, the MEK gene is frequently mutated. Binimetinib targets MEK.
You may be able to join this trial if you:
Have BRAF wild-type HCL or HCLv
Do not have the BRAF mutation
Have received at least one prior treatment with a purine analog, such as cladribine or pentostatin
Need treatment, as shown by blood counts or an enlarged spleen
Do not have an uncontrolled infection, heart or lung problems, or another cancer that needs treatment
Have not received any treatment in the 4 weeks before the study begins
Meet the study’s other lab and health requirements.
Who to contact about this trial:
Holly M Eager, R.N.; (240) 858-7229; holly.eager@nih.gov
…
Cladribine and Rituximab in Treating Patients with Hairy Cell Leukemia
Learn more about this trial. (link to trial here)
What are the primary objectives of this clinical trial?
To study the combination of cladribine followed by rituximab in people with HCL, and
Determine how effective this approach is at achieving complete remission, eliminating minimal residual disease (MRD), and improving long-term outcomes.
You may be able to join this trial if you have:
Have HCL
If relapsed, have had no more than one prior treatment
Who to contact about this trial:
Farhad Ravandi, MD
Phone: 713-792-7305 or Email: fravandi@mdanderson.org
Clinical Trials by Type of HCL
Studies that Do Not Include Treatment
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Venetoclax for People With Relapsed HCL
Learn more about this trial (link to trial here)
What is the primary objective of this clinical trial?
To determine the objective response rate (ORR) of venetoclax in patients with HCL that has returned after improvement.
Venetoclax belongs to a group of drugs called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop cancer cells from growing by blocking BCL-2, a protein that cancer cells need to survive. Venetoclax comes in a tablet form.
ORR is the percentage of people in a study who have a partial or complete response to treatment within a certain period. A partial response is a decrease in tumor size or cancer amount, and a complete response is the disappearance of all cancer signs. Measuring ORR in a clinical trial shows how well a new treatment works.
You may be able to join this trial if you:
Have relapsed hairy cell leukemia (HCL) or relapsed HCL variant (HCLv)
Have previously received purine analog treatment
Were treated using BRAF inhibitors, but relapsed, or are ineligible for BRAF inhibitors
Have not previously been treated with venetoclax
Need treatment because your disease is active
Meet the study’s other lab and health requirements
Who to contact about this trial:
This study has 21 locations, including sites in California, Florida, Kansas, Missouri, and Maryland.
Robert J Kreitman from the NCI is the Principal Investigator.
Phone: 800-411-1222
…
Tovorafenib + rituximab in recurrent/refractory classic HCL and comparing with cladribine + rituximab in untreated classic HCL
Learn more about this trial. (link to trial here)
What are the primary objectives of this clinical trial?
To evaluate the safety and tolerability of tovorafenib plus rituximab in patients with relapsed or refractory HCL, and
To determine the MRD-negative complete remission rate of tovorafenib plus rituximab compared to cladribine plus rituximab for untreated HCL.
Tovorafenib is a drug used to treat pediatric cancer that is being studied in other types of cancer, including HCL. Tovorafenib blocks certain proteins made by the mutated BRAF gene.
Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some cancer cells.
You may be eligible to join this trial if you:
Have BRAF-positive HCL
Have had prior therapy with at least one purine analog (fludarabine, pentostatin, or cladribine) unless you are ineligible.
Need treatment
Meet the study’s other lab and health requirements.
Who to contact about this trial:
This study has 4 locations, including sites in Maryland, Ohio, Pennsylvania, and Virginia.
The principal investigator for this trial is Seema A. Bhat, The Ohio State University Comprehensive Cancer Center.
Phone number: 800-293-5066
Email address: Jamesline@osumc.edu
…
Vemurafenib plus Obinutuzumab Vs. Cladribine plus Rituximab in Previously Untreated HCL
Learn more about this trial. (link to trial here)
View the webinar about this study.>>
What is the primary objective of this clinical trial?
Study the safety of vemurafenib in combination with obinutuzumab compared to the standard approach of cladribine in combination with rituximab.
The researchers will examine which treatment causes fewer or milder side effects and which approach is more effective at eliminating cancer cells.
Vemurafenib is a drug that blocks proteins produced by the BRAF V600E mutation.
Obinutuzumab is a medicine used in combination with other drugs to treat certain types of cancer. Obinutuzumab binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of leukemia and lymphoma cells. Obinutuzumab blocks CD20 and helps the immune system kill cancer cells. It is a type of monoclonal antibody.
You may be able to join this trial if you:
Have classical HCL
Have the BRAF V600E mutation; if unsure, repeat BRAF testing.
Have not received any prior therapy for HCL
Need treatment
Meet the study’s other lab and health requirements.
Who to contact about this trial:
Jae Park, MD Email: parkj6@mskcc.org
Study back-up contact: Mark Geyer, MD Phone Number: 646-608-3745
…
Phase I Study of Anti-CD22 CAR T-Cell Therapy for Patients with Relapsed or Refractory Hairy Cell Leukemia (HCL) And HCL Variant (HCLv)
Learn more about this trial. (link to trial here)
What is the primary objective of this clinical trial?
To see if anti-CD22 CAR T-cells are safe and effective for people with HCL or HCLv after they have received a treatment regimen of cyclophosphamide and fludarabine.
CAR (Chimeric Antigen Receptor) T-cell therapy is a type of cancer treatment in which a person’s T cells (a type of immune cell) are changed in a laboratory to recognize and attack cancer cells.
You may be able to join this trial if you:
Have HCL or HCLv
Have previously received treatment or been ineligible for: 1) Chemotherapy combined with Rituximab, 2) moxetumomab pasudotox, and/or 3) a BRAF inhibitor such as Vemurafenib.
Need treatment
Meet the study’s other lab and health requirements.
Who to contact about this trial:
This study has one location.
Olena Sierra: (240) 858-3185 or olena.sierraortiz@nih.gov
…
Encorafenib plus Binimetinib is being studied for people with BRAF V600E-mutated relapsed or refractory Hairy Cell Leukemia (HCL).
Learn more about this trial. (link to trial here)
What is the primary objective of this clinical trial?
This trial is testing whether treating BRAF-positive HCL with both encorafenib and binimetinib works better than vemurafenib alone.
Encorafenib is a medicine often given with other drugs, like binimetinib, to treat some cancers. It works by blocking proteins made by the mutated BRAF gene. It comes in a capsule form.
Binimetinib is a medicine that blocks proteins called MEK1 and MEK2. It comes in a tablet form.
You may be eligible to join this trial if you:
Have BRAF-positive HCL that did not respond to treatment or has returned after treatment
Have had at least one previous purine analog treatment, such as cladribine or pentostatin
Currently need treatment
Do not have an uncontrolled infection, serious heart or lung problems, or another cancer that also needs treatment
Have not received any treatment in the four weeks before the study starts
Who to contact about this trial:
This study has one location.
Dr. Robert J. Kreitman
kreitmar@mail.nih.gov or 301-648-7375
Holly M Eager, R.N.
holly.eager@nih.gov or (240) 858-7229
…
Cladribine and Rituximab in Treating Patients with Hairy Cell Leukemia
Learn more about this trial. (link to trial here)
What are the primary objectives of this clinical trial?
To study the combination of cladribine followed by rituximab in people with HCL, and
Determine how effective this approach is at achieving complete remission, eliminating minimal residual disease (MRD), and improving long-term outcomes.
You may be able to join this trial if you:
Have HCL
If relapsed, have had no more than one prior treatment
Who to contact about this trial:
Farhad Ravandi, MD
Phone: 713-792-7305 or Email: fravandi@mdanderson.org
-
Venetoclax for People With Relapsed HCL
Learn more about this trial (link to trial here)
What is the primary objective of this clinical trial?
To determine the objective response rate (ORR) of venetoclax in patients with HCL that has returned after improvement.
Venetoclax belongs to a group of drugs called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop cancer cells from growing by blocking BCL-2, a protein that cancer cells need to survive. It comes in a tablet form.
ORR is the percentage of people in a study who have a partial or complete response to treatment within a certain period. A partial response is a decrease in tumor size or cancer amount, and a complete response is the disappearance of all cancer signs. Measuring ORR in a clinical trial shows how well a new treatment works.
You may be able to join this trial if you:
Have relapsed hairy cell leukemia (HCL) or relapsed HCL variant (HCLv)
Have previously received purine analog treatment
Were treated using BRAF inhibitors, but relapsed, or are ineligible for BRAF inhibitors
Have not previously been treated with venetoclax
Need treatment because your disease is active
Meet the study’s other lab and health requirements
Who to contact about this trial:
This study has 21 locations, including sites in California, Florida, Kansas, Missouri, and Maryland.
Robert J Kreitman from the NCI is the Principal Investigator.
Phone: 800-411-1222
…
Binimetinib for people with relapsed/refractory BRAF Wild Type HCL and Variant
Learn more about this trial. (link to trial here)
What is the primary objective of this clinical trial?
To see if binimetinib is an effective treatment for people with HCL that does not have a BRAF mutation.
Most people with HCL have a BRAF gene mutation. They can be treated with BRAF inhibitors, drugs that target this mutation. For people who do not have this mutation, BRAF inhibitors are not a treatment option. The researchers found that when HCL does not have the BRAF mutation, the MEK gene is frequently mutated. Binimetinib targets MEK.
You may be able to join this trial if you:
Have BRAF wild-type HCL or HCLv
Do not have the BRAF mutation
Have received at least one prior treatment with a purine analog, such as cladribine or pentostatin
Need treatment, as shown by blood counts or an enlarged spleen
Do not have an uncontrolled infection, heart or lung problems, or another cancer that needs treatment
Have not received any treatment in the 4 weeks before the study begins
Meet the study’s other lab and health requirements.
Who to contact about this trial:
Holly M Eager, R.N.; (240) 858-7229; holly.eager@nih.gov
…
Phase I Study of Anti-CD22 Chimeric Receptor T-Cells in patients with relapsed/refractory Hairy Cell Leukemia and Variant
Learn more about this clinical trial. (link to trial here)
What is the primary objective of this clinical trial?
To see if anti-CD22 CAR T-cells are safe and effective for people with HCL or HCLv after they have received a treatment regimen of cyclophosphamide and fludarabine.
CAR (Chimeric Antigen Receptor) T-cell therapy is a type of cancer treatment in which a person’s T cells (a type of immune cell) are changed in a laboratory to recognize and attack cancer cells.
You may be able to join this trial if you:
Have HCL or HCLv
Have previously received treatment or been ineligible for: 1) Chemotherapy combined with Rituximab, 2) moxetumomab pasudotox, and/or 3) a BRAF inhibitor such as Vemurafenib.
Need treatment
Meet the study’s other lab and health requirements.
Who to contact about this trial:
This study has one location.
Olena Sierra: (240) 858-3185 or olena.sierraortiz@nih.gov
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These studies do not include any treatments or medications. Instead, people with HCL and/or HCLv can help research by donating blood, bone marrow, or other samples. Researchers use these samples to learn more about the disease.
Collection of Human Samples to Study HCL and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Learn more about this trial. (link to trial here)
What are the primary objectives of this study?
To study HCL and how the disease compares with other disorders.
To collect a variety of clinical samples, including blood, urine, lymph samples, and other tissues, in order to study the samples and develop new treatments for HCL. Individuals who have HCL will be asked to provide blood, bone marrow, urine, and tumor tissue samples as requested by the researchers. Healthy volunteers will provide only blood and urine samples.
No treatment will be given as part of this study.
You may be able to join this trial if you:
Have HCL or HCLv
Who to contact about this study:
Julie C Feurtado, R.N.
(301) 480-6186 or julie.feurtado@nih.gov
…
Decoding the Extracellular Vesicles-Driven Crosstalk in Hairy Cell Leukemia
Learn more about this study. (link to study here)
What are the primary objectives of this study?
To better understand how extracellular vesicles - small particles released by cells - may contribute to the development and progression of HCL.
To study the communication between HCL cells and their surrounding environment, Biomarkers that may help predict disease behavior, and Potential new targets for future treatments.
Participants agree to provide samples that researchers use to investigate the biology of HCL. No experimental treatment is administered as part of the study.
You may be able to join this trial if you:
Have HCL
Are willing to provide blood and/or biological samples for research
Who to contact about this study:
Name: Lucia Catani, PhD
Phone Number: +390512143837
Email: lucia.catani@unibo.it
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Hairy Cell Leukemia is a rare disease and patients receive care from different doctors around the world. This makes it challenging for researchers to identify patterns, study unanswered questions, and develop more effective treatments.
Every piece of information collected for the registry strengthens research to improve diagnosis, treatment, and quality of life for people with HCL and HCL variants.
FOR MORE INFORMATION >> Click here (link to registry page)
Registry team contact information:
Phone: (614) 685-0635 Email: HCLRegistry@osumc.edu
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Assessing Medical Trial Experiences of Hairy Cell Leukemia Patients
Learn more about this trial. (link to trial here)
What are the primary objectives of this study?
To better understand the factors that influence a person's decision to participate in, discontinue, or rejoin a clinical trial for hairy cell leukemia.
Researchers hope to learn more about:
Barriers to clinical trial participation
Patient experiences during clinical trials
Factors that affect enrollment decisions
Ways to improve access to future clinical trials
This is a survey-based observational study. No treatment is provided as part of the study.
You may be able to join this trial if you:
Have a diagnosis of hairy cell leukemia
Have experience with, or have considered, participation in a clinical trial
Are willing to complete study questionnaires or interviews
Who to contact about this study:
Michael B. Gill
Email: michael@powerlifesciences.com
View our HCL Clinical Trials Series Webinars
Below are webinars hosted by the Hairy Cell Leukemia Foundation. Researchers in charge of important clinical trials in HCL participated as speakers.
Comparing Vemurafenib+Obinutuzumab versus Cladribine+Rituximab
Dr. Jae Park, Memorial Sloan Kettering
In this webinar, Dr. Park discusses new chemotherapy-free treatment approaches for Hairy Cell Leukemia. He explains how targeted therapies focused on the BRAF mutation are showing promising results, including deep remissions, fewer infections, and faster recovery compared to traditional chemotherapy. The webinar also highlights an ongoing clinical trial comparing these newer treatments with standard therapy for newly diagnosed patients.
This trial is featured above under randomized (Chemo - Non-chemo)
HCL Clinical Trials at the National Cancer Institute (NCI)-NIH
Dr. Robert Kreitman, NCI-NIH
In this webinar, Dr. Kreitman discusses the latest clinical trials and treatment advances for Hairy Cell Leukemia and HCL variant at the National Cancer Institute. The seminar highlights targeted therapies, BRAF and MEK inhibitors, CAR-T therapy, and emerging treatments designed to improve outcomes for patients with relapsed or difficult-to-treat disease. Dr. Kreitman also explains the importance of molecular testing, minimal residual disease (MRD), and participation in clinical trials to help advance future HCL treatments.
Clinical Trials No Longer Recruiting Patients
These studies are no longer enrolling new participants but may provide valuable information about past and ongoing research.
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Low Dose Vemurafenib and Rituximab
Learn more about this study. >>
View the webinar about this study.>>
Brief summary
The treatment involved 8 weeks of treatment with an oral drug called vemurafenib and 8 doses of an intravenous medication called rituximab.
This study used a lower dose of vemurafenib than previous studies have used, with the goal of minimizing side effects from this medication.
Contacts at Scripps Clinic:
David J Hermel, MD Phone Number: 858-554-8788 Email: hermel.david@scrippshealth.org
This study is not currently recruiting patients.
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A Phase II study of the BRAF inhibitor, vemurafenib, plus obinutuzumab in patients with previously untreated HCL
Learn more about this study. >>
Purpose:
The researchers conducted a phase II clinical trial combining the BRAF inhibitor, vemurafeinb, and anti-CD20 antibody, obinutuzumab, in patients with previously untreated HCL to achieve a deeper molecular response with more favorable side effect profile and durable remissions.
This study is not currently recruiting patients.
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Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory HCL
Learn more about this study. >>
Purpose: To achieve complete remission without minimal residual disease, to prevent relapse.
This study is not currently recruiting patients.
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Cladribine and rituximab for people with once-relapsed HCL
Learn more about this study. >>
Purpose: To achieve complete remission without minimal residual disease, to prevent relapse.
This study is not currently recruiting patients.
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Moxetumomab Pasudotox and rituximab for relapsed Hairy Cell Leukemia
Learn more about this study. >>
Purpose: To test the safety of Moxetumomab pasudotox (Lumoxiti) taken with Rituximab for people with HCL or HCL variant, both agents already approved for HCL or commonly used for HCL.
This study is not currently recruiting patients.
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Multicenter phase 2 study of the bruton’s tyrosine kinase inhibitor pci-32765 (ibrutinib) for treatment of relapsed HCL
See the Webinar about this study.>>
Purpose:
Determine the response rate of HCL after 32 weeks of single-agent ibrutinib treatment.
Learn more about this study. >>
This study is not currently recruiting patients.
What is a clinical trial?
Clinical trials are carefully controlled research studies that are necessary to develop and evaluate ways to improve treatment and quality of life for patients with hairy cell leukemia. Clinical trials may be available for patients at any stage of HCL and HCLv.
Can I join a clinical trial?
Your eligibility for a clinical trial depends on a variety of factors, such as whether you have HCL or an HCL variant, your stage of disease, your age and gender, and the type of treatment, if any, that you’ve already received.
We encourage you to discuss clinical trials with your doctor and healthcare team to consider the availability of a trial for your unique diagnosis, treatment history, and needs.
Before joining a trial, consider asking:
As you review your options with your doctor, you will want to understand the purpose and length of a given clinical study; potential benefits and risks; costs of the study, including any charges you will be responsible for; your responsibilities and limitations during the trial, including travel requirements; and whether you will continue to see your own doctor during the trial.
ClinicalTrials.gov : Explore more Clinical Trials
You may want to explore www.ClinicalTrials.gov, a registry of federally and privately supported clinical trials in the United States and around the world. This website is a service of the U.S. National Institutes of Health (NIH). Once on the www.ClinicalTrials.gov website, you can enter “hairy cell leukemia” in the “Condition or Disease” box and click “Search” for a list of relevant trials. You can also specify a “Country” to narrow your search.