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Phase II Trial Of BL22 Immunotoxin In Hairy Cell Leukemia


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

Phase II Trial Of BL22 Immunotoxin In Hairy Cell Leukemia


OBJECTIVES:

Primary

- Determine the response rate in patients with cladribine-resistant hairy cell leukemia
treated with BL22 immunotoxin.

Secondary

- Determine the response duration in patients treated with this drug.

- Determine the safety of this drug in these patients.

- Determine the pharmacokinetics of this drug in these patients.

- Correlate BL22 blood levels and toxicity of this drug with the development of
neutralizing antibodies in these patients.

OUTLINE: Patients receive BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 followed
by rest.

Patients are then evaluated at 8 weeks. Patients achieving complete hematologic remission
are followed. All other patients continue to receive BL22 immunotoxin as above on days 1, 3,
and 5. Treatment repeats every 4 weeks for up to a total of 16 courses in the absence of
disease progression or unacceptable toxicity. Patients achieving CR without minimal residual
disease (MRD) receive 2 courses beyond CR. Patients achieving CR with MRD receive 4 courses
beyond CR.

Patients are followed every 4 months for 1 year, every 6 months for 1 year, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed hairy cell leukemia

- CD22-positive disease by fluorescence-activated cell sorting with anti-CD22 antibody

- Meets at least 1 of the following indications for treatment:

- Absolute neutrophil count less than 1,000/mm^3

- Hemoglobin less than 10 g/dL

- Platelet count less than 100,000/mm^3

- Absolute lymphocyte count greater than 20,000/mm^3

- Symptomatic splenomegaly

- Meets 1 of the following response criteria:

- No response

- Complete response (CR) or partial response (PR) less than 2 years in duration
after the last course of prior cladribine

- CR or PR less than 4 years in duration after a second or later course of prior
cladribine

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- See Disease Characteristics

Hepatic

- AST and ALT no greater than 2.5 times upper limit of normal (ULN)

- Bilirubin no greater than 2.2 mg/dL

- Albumin at least 3.0 g/dL

Renal

- Creatinine no greater than 1.4 mg/dL OR

- Creatinine clearance at least 50 mL/min

Cardiovascular

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No serum that neutralizes more than 75% of the activity of 1 µg/mL of BL22
immunotoxin using a bioassay

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance

- No other concurrent uncontrolled illness that would preclude study participation

- Understand and give informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior BL22 immunotoxin

- More than 12 weeks since prior monoclonal antibody therapy

Chemotherapy

- See Disease Characteristics

- More than 4 weeks since prior systemic cytotoxic chemotherapy

Endocrine therapy

- More than 4 weeks since prior systemic steroids (except stable doses of prednisone no
greater than 20 mg/day)

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

After even cycle numbers (2,4,6,8,10)

Safety Issue:

No

Principal Investigator

Robert Kreitman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000341680

NCT ID:

NCT00074048

Start Date:

October 2003

Completion Date:

July 2008

Related Keywords:

  • Leukemia
  • refractory hairy cell leukemia
  • Leukemia
  • Leukemia, Hairy Cell

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, Maryland  20892-1182