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Immunotoxin Therapy in Treating Patients With Hairy Cell Leukemia

Phase I Study of BL22, a Recombinant Immunotoxin for Treatment of CD22+ Leukemias and Lymphomas

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00021983
Enrollment
Unknown
Registered
2003-12-12
Start date
1998-12-31
Completion date
Unknown
Last updated
2015-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

refractory hairy cell leukemia

Brief summary

RATIONALE: An immunotoxin can locate cancer cells and kill them without harming normal cells. This may be an effective treatment for hairy cell leukemia. PURPOSE: Phase I trial to study the effectiveness of BL22 immunotoxin in treating patients who have refractory or recurrent hairy cell leukemia.

Detailed description

OBJECTIVES: * Assess the toxicity and therapeutic efficacy of recombinant BL22 immunotoxin in patients with refractory or recurrent CD22+ hairy cell leukemia. * Define the pharmacokinetics of this drug, including the terminal elimination serum half-life area under the curve and volume of distribution, in these patients. * Evaluate the immunogenicity of this drug in these patients. * Determine the effect of this drug on various components of the circulating cellular immune system in these patients. OUTLINE: This is a dose-escalation study. Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats at least every 42 days for up to 4 courses in the absence of disease progression and sufficient neutralizing antibodies. Cohorts of 3-6 patients receive escalating doses of recombinant BL22 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity. PROJECTED ACCRUAL: A maximum of 46 patients will be accrued for this study within 3 years.

Interventions

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed refractory or recurrent hairy cell leukemia * Relapsed after less than 2 years of complete remission after purine analog therapy * Must have at least one of the following indications for therapy: * Progressive or massive splenomegaly * Cytopenia defined by the following: * Absolute neutrophil count less than 1,000/mm\^3 OR * Platelet count less than 100,000/mm\^3 OR * Hemoglobin less than 12 g/dL * More than 20,000 hairy cells/mm\^3 * Symptomatic adenopathy * Constitutional symptoms including tumor-related fever or bone pain * Evidence of CD22 positivity by 1 of the following: * More than 15% of malignant cells from a site must react with anti-CD22 by immunohistochemistry * More than 30% of malignant cells from a site CD22+ by fluorescent-activated cell sorter * More than 400 CD22 sites/cell (average) on malignant cells as assessed by radiolabeled anti-CD22 binding * No CNS disease requiring treatment * No patients whose serum neutralizes BL22 immunotoxin in tissue culture, due to either antitoxin or antimouse-IgG antibodies * No patients whose serum neutralizes more than 75% of the activity of 1 microgram/mL of BL22 immunotoxin PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * More than 6 months Hematopoietic: * See Disease Characteristics * Pancytopenia due to disease allowed Hepatic: * ALT and AST less than 2.5 times upper limit of normal (ULN) * Bilirubin less than 1.5 times ULN Renal: * Creatinine no greater than 2.0 mg/dL Pulmonary: * FEV1 at least 60% of predicted * DLCO at least 55% of predicted Other: * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior bone marrow transplantation allowed * At least 3 weeks since prior interferon for the malignancy * More than 3 months since prior monoclonal antibody therapy (e.g., rituximab) Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior cytotoxic chemotherapy for the malignancy Endocrine therapy: * Not specified Radiotherapy: * At least 3 weeks since prior whole body electron beam radiotherapy for the malignancy * Radiotherapy within the past 3 weeks allowed provided less than 10% of total bone marrow was treated and patient has measurable disease outside the radiation port Surgery: * Not specified Other: * At least 3 weeks since prior retinoids for the malignancy * At least 3 weeks since any other prior systemic therapy for the malignancy * No concurrent therapeutic warfarin

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026