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

Phase 1

Suspended

• Conditions: Leukemia; Lymphoma
• Interventions: Drug: BL22 immunotoxin; Procedure: antibody-drug conjugate therapy; Procedure: immunotoxin therapy; Procedure: monoclonal antibody therapy

• Registration Number: NCT00077493
• Lead Sponsor: MedImmune LLC

Brief 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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2004-02-10
• Study First Submitted QC: 2004-02-11
• Study First Posted: 2004-02-12
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-21
• Last Update Posted: 2007-12-28
• Primary Completion: 2008-10
• Study Completion: 2008-10

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	BL22 immunotoxin	BL22 immunotoxin
2	antibody-drug conjugate therapy	antibody therapy
3	immunotoxin therapy	immunotoxin therapy
4	monoclonal antibody therapy	monoclonal antibody therapy

Primary Outcome Measures

Name	Time	Method
assessment of efficacy, safety, pharmacokinetics, immunogenicity.	end of study

Secondary Outcome Measures

Name	Time	Method
Expansion of MTD	end of study

Trial Locations

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office; 🇺🇸 Bethesda, Maryland, United States