BL-22 Trial
Home Up BL22 BL-22 Trial 2- CdA Treatment Modes

 

PHASE II

There is a Phase II trial of BL22.  For more information, please contact Eugene Farrell, Secretary Treasurer - Hairy Cell Leukemia Research Foundation at (800) 693-6173   Access Code: 54.

 

The Inclusion criteria is as follows:

1.  Histopathological evidence of CD22+ HCL confirmed by the NIH pathology department.  This will require a monoclonal population of periphereral malignant lymphocytes that are CD22 positive by fluorescence activated cell sorting (FACS) with anti-CD22 antibody.  Positive expression in a FACS assay is defined as more than 2 times the mean fluorescence intensity (MFI) of the control antibody by FACS.

2.  At least one of the following indications for treatment:  neutopenia (ANC<1000 cells/ul), anemia (Hgb<10g/dL), thrombocytopenia (Plt<100,000/ul), an absolute lymphocyte count of >20,000 cells/ul, or symptomatic splenomegaly.

3.  No response or less than a 2 year duration of complete remission or partial remission after the last course of cladribine, or less than a 4 year duration of CR or PR to a 2nd or later course of cladribine.

4.  ECOG performance status of 0-2.

5.  At least 18 years old.

6.  Understand and give informed consent.

7.  A negative pregnancy test in female patients of childbearing potential.  women must not be breast-feeding.

8.  ALT and AST <2.5-times the upper limits of normal.  Albumin <3.0 gm/dL.  Total bilirubin <2.2 mg/dL.

9.  Creatinine <1.4 mg/dL or cratinine clearance >50 ml/min.

10.  Serum that neutralizes <75% of the activity of 1 ug/mL of BL22 using a bioassay.

11.  No systemic cytotoxic chemotherapy within 4 weeks of enrollment or systemic steroids (except stable doses of Prednisone <20 mg/day) within 4 weeks of enrollment.

12.  No monoclonal antibody therapy within 12 weeks of enrollment.

13.  No prior treatment with BL22.

14.  Patients may not be receiving any other investigational agents.

15.  Patients should not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.