NCT00077493

BL22 Immunotoxin In Treating Young Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma

Pediatric Phase I Trial of BL22 for Refractory CD22-Positive Leukemias and Lymphomas

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (estimated)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 6 Months – 24 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: BL22 immunotoxin can locate tumor cells and kill them without harming normal cells. BL22 immunotoxin may be effective in treating relapsed or refractory acute lymphoblastic leukemia and non-Hodgkin's lymphoma. PURPOSE: This phase I trial is studying the side effects and best dose of BL22 immunotoxin in treating young patients with relapsed or refractory acute lymphoblastic leukemia or non-Hodgkin's lymphoma.

Detailed description

OBJECTIVES: Primary * Determine the toxic effects of BL22 immunotoxin in pediatric patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia or non-Hodgkin's lymphoma. * Determine the maximum tolerated dose of this drug in these patients. * Determine the immunogenicity of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. Secondary * Determine the in vitro cytotoxicity of this drug against lymphoblasts from patients with acute lymphoblastic leukemia. * Determine the therapeutic efficacy of this drug in inducing remissions in these patients. * Determine changes in lymphocyte subsets, immunoglobulin levels, serum cytokines, and soluble cytokine receptor levels in patients treated with this drug. OUTLINE: This is a non-randomized, dose-escalation study. Patients receive BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 OR on days 1, 3, 5, 7, 9, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) or unconfirmed CR (CRu) receive 2 additional courses beyond CR or CRu for a maximum of 6 courses. Cohorts of 3-6 patients receive escalating doses of BL22 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, the cohort is expanded and a total of 12 patients are treated at that dose. Patients are followed weekly for at least 1 month and then every 1-3 months thereafter. PROJECTED ACCRUAL: A total of 95 patients will be accrued for this study.

Conditions

• Leukemia
• Lymphoma

Interventions

Type	Name	Description
DRUG	BL22 immunotoxin	BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 OR on days 1, 3, 5, 7, 9, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) or unconfirmed CR (CRu) receive 2 additional courses beyond CR or CRu for a maximum of 6 courses.
PROCEDURE	antibody-drug conjugate therapy	CD22 antibody, RFB4 on day 7
PROCEDURE	immunotoxin therapy	tested for immunogenicity to CAT-8015 before each cycle and at end of study.
PROCEDURE	monoclonal antibody therapy	administered intravenously over 30 minutes.

Timeline

• Start date: 2004-01-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2004-02-12
• Last updated: 2007-12-28

Locations

1 site across 1 country: United States