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| Sponsor: | MedImmune LLC |
|---|---|
| Information provided by: | MedImmune LLC |
| ClinicalTrials.gov Identifier: | NCT00126646 |
Purpose
RATIONALE: BL22 immunotoxin can find tumor cells and kill them without harming normal cells.
PURPOSE: This phase I trial is studying the side effects and best dose of BL22 immunotoxin in treating patients with refractory B-cell chronic lymphocytic leukemia, prolymphocytic leukemia, or non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Drug: BL22 immunotoxin Procedure: antibody-drug conjugate therapy Procedure: immunotoxin therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of BL22, A Recombinant Immunotoxin for Chronic Lymphocytic Leukemia and CD22+ Lymphomas |
| Estimated Enrollment: | 24 |
| Study Start Date: | June 2005 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a nonrandomized, dose-escalation study. Patients are stratified according to disease type (chronic lymphocytic leukemia vs non-Hodgkin's lymphoma).
Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats ≥ every 27 days for up to 6 courses in the absence of neutralizing antibodies to BL22 or PE38, disease progression, or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR. Patients who relapse from a CR lasting ≥ 6 months may receive additional courses.
Cohorts of 3-6 patients per stratum receive escalating doses of recombinant 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.
PROJECTED ACCRUAL: A total of 24 patients (12 per stratum) will be accrued for this study within 1-2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of B-cell leukemia or lymphoma of 1 of the following types:
Chronic lymphocytic leukemia
Prolymphocytic leukemia
Indolent non-Hodgkin's lymphoma, including mantle cell lymphoma
CD22-positive disease, as evidenced by 1 of the following:
Treatment is medically indicated, as evidenced by any of the following:
No neutralizing anti-toxin or anti-mouse immunoglobulin G (IgG) antibodies to BL22 or PE38
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
More than 1 week since prior steriods
Radiotherapy
More than 3 weeks since prior whole-body electron beam radiotherapy
Surgery
Other
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Principal Investigator: | Robert Kreitman, MD | National Cancer Institute (NCI) |
More Information
| Responsible Party: | Robert Kreitman , MD, NCI |
| ClinicalTrials.gov Identifier: | NCT00126646 History of Changes |
| Obsolete Identifiers: | NCT00114751 |
| Other Study ID Numbers: | CDR0000438672, NCI-05-C-0171, NCI-P6620, NCI-5336 |
| Study First Received: | August 2, 2005 |
| Last Updated: | June 17, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
B-cell chronic lymphocytic leukemia refractory chronic lymphocytic leukemia recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma recurrent marginal zone lymphoma splenic marginal zone lymphoma stage III marginal zone lymphoma |
stage IV marginal zone lymphoma recurrent mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma recurrent small lymphocytic lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma recurrent adult diffuse small cleaved cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage IV adult diffuse small cleaved cell lymphoma Waldenstrom macroglobulinemia prolymphocytic leukemia |
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Prolymphocytic Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Antibodies Immunotoxins Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |