Below is a list of clinical trials currently underway in hairy cell leukemia. Each link will take you to www.ClinicalTrials.gov, a registry of federally and privately supported clinical trials in the United States and around the world. www.ClinicalTrials.gov is a service of the U.S. National Institutes of Health. We recommend that you contact your physician and/or one of our Centers of Excellence to see if a clinical trial is right for you.

For general information about clinical trials, go to http://www.clinicaltrials.gov/ct2/about-studies/learn.

Clinical Trials in the US

TITLE:

A Multicenter Phase 2 Study of the Bruton’s Tyrosine Kinase Inhibitor PCI-32765 (Ibrutinib) for Treatment of Relapsed Hairy Cell Leukemia

BRIEF DESCRIPTION:

This phase II trial studies how well ibrutinib works in treating patients with relapsed hairy cell leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PHASE: 2

GET DETAILS:

http://www.clinicaltrials.gov/ct2/show/NCT01841723?term=hairy+cell+leukemia&recr=Open&rank=3

TITLE:

A Phase II Study of the BRAF Inhibitor, Vemurafenib, in Patients With Relapsed or Refractory Hairy Cell Leukemia

BRIEF DESCRIPTION:

The purpose of this study is to find out what effects, good and/or bad, treatment with vemurafenib (also known as Zelboraf™) has on the patient and on leukemia. Specifically, the researchers want to know how well vemurafenib eliminates leukemia from the blood.

PHASE: 2

GET DETAILS:

http://www.clinicaltrials.gov/ct2/show/NCT01711632?term=hairy+cell+leukemia&recr=Open&rank=4

TITLE:

Randomized Trial of Cladribine (CdA) With Simultaneous or Delayed Rituximab to Eliminate Hairy Cell Leukemia Minimal Residual Disease

BRIEF DESCRIPTION:

To determine if HCL MRD differs at 6 months after cladribine with or without rituximab administered concurrently with cladribine.

PHASE: 2

GET DETAILS:

http://www.clinicaltrials.gov/ct2/show/NCT00923013?term=hairy+cell+leukemia&recr=Open&rank=2

TITLE:

A Pivotal Multicenter Trial of Moxetumomab Pasudotox in Relapsed/ Refractory Hairy Cell Leukemia

BRIEF DESCRIPTION:

Moxetumomab pasudotox is an experimental non-chemotherapy cancer treatment drug. It targets CD22, a molecule on the surface of essentially all hairy cell leukemia cells. Moxetumomab pasudotox binds to CD22, goes into the cell, and releases a toxin which kills the cell. In a phase I trial it had activity in relapsed/refractory hairy cell leukemia with safety profile supporting further clinical study (http://ncbi.nlm.nih.gov/pubmed/22355053). This is a phase III multicenter trial designed to confirm these results.

PHASE: 3

GET DETAILS:

http://www.clinicaltrials.gov/ct2/show/NCT01829711?term=hairy+cell+leukemia&rank=14

TITLE:

Phase II Study of 2-Chlorodeoxyadenosine (2CDA) Followed By Rituximab in Hairy Cell Leukemia

BRIEF DESCRIPTION:

The goal of this clinical research study is to learn if treatment with 2CDA (cladribine) followed by treatment with rituximab can help to control HCL. The safety of this combination treatment will also be studied.

PHASE: 2

GET DETAILS:

http://www.clinicaltrials.gov/ct2/show?term=hairy+cell+leukemia&recr=Open&rank=7

TITLE:

A Phase II, Open-label, Study in Subjects With BRAF V600E-Mutated Rare Cancers With Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib

BRIEF DESCRIPTION:

This is a Phase II, open-label, non-randomized, multi-center study of oral Dabrafenib in combination with oral Trametinib in subjects with rare cancers including anaplastic thyroid cancer, biliary tract cancer, gastrointestinal stromal tumor, non-seminomatous germ cell tumor/non-geminomatous germ cell tumor, hairy cell leukemia , World Health Organization (WHO) Grade 1 or 2 glioma, WHO Grade 3 or 4 (high-grade) glioma, multiple myeloma, and adenocarcinoma of the small intestine, with BRAF V600E positive-mutations. This study is designed to determine the overall response rate (ORR) of oral Dabrafenib in combination with oral Trametinib in subjects with rare BRAF V600E mutated cancers. Subjects will need to have a fresh or frozen tumor tissue sample provided to confirm the BRAF V600E mutation status. Only subjects with histologically confirmed advanced disease and no available standard treatment options will be eligible for enrollment. Subjects will undergo screening assessments within 14 days (up to 35 days for ophthalmology exam, echocardiogram or disease assessments) prior to the start of treatment to determine their eligibility for enrollment in the study.

PHASE: 2

GET DETAILS:

http://www.clinicaltrials.gov/ct2/show/NCT02034110?term=hairy+cell+leukemia+BRAF+V600&rank=2

TITLE:

A Phase II Clinical Trial of Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin for CD25 Positive Hairy Cell Leukemia

BRIEF DESCRIPTION:

The purpose of this study is to determine the activity of anti-Tac(Fv)-PE38 (LMB-2) in patients with CD25-expressing hairy cell leukemia (HCL). The primary endpoint of this trial is response rate. We will also evaluate response duration, LMB-2 immunogenicity, pharmacokinetics, toxicity, and monitor soluble Tac levels in the serum.

PHASE: 2

GET DETAILS:

https://www.clinicaltrials.gov/ct2/show/NCT00321555?term=hairy+cell+leukemia&rank=2

TITLE:

Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia

BRIEF DESCRIPTION:

• To determine whether rituximab with either pentostatin or bendamustine is a more effective treatment for HCL than rituximab alone.
• To determine whether pentostatin or bendamustine is a more effective treatment for HCL when combined with rituximab.

PHASE: 2

GET DETAILS:

https://www.clinicaltrials.gov/ct2/show/NCT01059786?term=hairy+cell+leukemia&rank=5

TITLE:

Collection of Human Samples to Study Hairy Cell and Other Leukemias and to Develop Recombinant Immunotoxins for Cancer Treatment

BRIEF DESCRIPTION:

To allow the collection of a variety of clinical samples, including blood, urine, lymphopheresis samples, and other tissues, to better understand the disease processes which are being studied, or to determine eligibility and/or optimal timing for clinical testing. Specific projects planned may include:
• studying antibodies made against immunotoxins
• quantifying tumor antigens by flow cytometry and other methods
• testing how well recombinant immunotoxins and other agents kill tumor cells ex vivo
• molecularly characterizing malignant B-cells by sequencing their immunoglobulin rearrangements and other genes. Imaging data may be obtained is needed to assess tumor burden to relate to lab values.

PHASE: N/A

GET DETAILS:

https://www.clinicaltrials.gov/ct2/show/NCT01087333?term=hairy+cell+leukemia&rank=18

 

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Studies Outside of the United States

TITLE:

A phase II, multi-center, open label study of the clinical activity and safety of the BRAF-V600 inhibitor vemurafenib (PLX-4032) in previously treated patients with hairy cell leukemia (HCL) carrying the BRAF-V600E mutation

BRIEF DESCRIPTION:

To determine the anti-tumor activity of the orally administered single agent vemurafenib (PLX-4032) in HCL patients carrying the BRAF-V600E mutation and showing an unsatisfactory response to or severe toxicity from purine analogues.

PHASE: 2

GET DETAILS:

https://www.clinicaltrialsregister.eu/ctr-search/search?query=hairy+cell+leukemia

TITLE:

Therapy Optimisation for the Treatment of Hairy Cell Leukemia

BRIEF DESCRIPTION:

The trial will test the effectiveness and toxicity of subcutaneous treatment with one cycle of cladribine in patients with hairy cell leukemia requiring treatment.
They have to be untreated so far or may be pretreated with alpha-interferon.

PHASE: 2 and 3

GET DETAILS:

http://www.clinicaltrials.gov/ct2/show/NCT02131753?term=hairy+cell+leukemia&recr=Open&rank=1

TITLE:

A Phase II, Open-label, Study in Subjects With BRAF V600E-Mutated Rare Cancers With Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib

BRIEF DESCRIPTION:

This is a Phase II, open-label, non-randomized, multi-center study of oral Dabrafenib in combination with oral Trametinib in subjects with rare cancers including anaplastic thyroid cancer, biliary tract cancer, gastrointestinal stromal tumor, non-seminomatous germ cell tumor/non-geminomatous germ cell tumor, hairy cell leukemia , World Health Organization (WHO) Grade 1 or 2 glioma, WHO Grade 3 or 4 (high-grade) glioma, multiple myeloma, and adenocarcinoma of the small intestine, with BRAF V600E positive-mutations. This study is designed to determine the overall response rate (ORR) of oral Dabrafenib in combination with oral Trametinib in subjects with rare BRAF V600E mutated cancers. Subjects will need to have a fresh or frozen tumor tissue sample provided to confirm the BRAF V600E mutation status. Only subjects with histologically confirmed advanced disease and no available standard treatment options will be eligible for enrollment. Subjects will undergo screening assessments within 14 days (up to 35 days for ophthalmology exam, echocardiogram or disease assessments) prior to the start of treatment to determine their eligibility for enrollment in the study.

PHASE: 2

GET DETAILS:

http://www.clinicaltrials.gov/ct2/show?term=hairy+cell+leukemia&recr=Open&rank=59