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Sponsors and Collaborators: |
MedImmune LLC Cambridge Antibody Technology |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00077493 |
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.
Condition | Intervention | Phase |
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Leukemia Lymphoma |
Drug: BL22 immunotoxin Procedure: antibody-drug conjugate therapy Procedure: immunotoxin therapy Procedure: monoclonal antibody therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study |
Official Title: | Pediatric Phase I Trial of BL22 for Refractory CD22-Positive Leukemias and Lymphomas |
Estimated Enrollment: | 95 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
BL22 immunotoxin
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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.
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2: Active Comparator
antibody therapy
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Procedure: antibody-drug conjugate therapy
CD22 antibody, RFB4 on day 7
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3: Active Comparator
immunotoxin therapy
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Procedure: immunotoxin therapy
tested for immunogenicity to CAT-8015 before each cycle and at end of study.
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4: Active Comparator
monoclonal antibody therapy
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Procedure: monoclonal antibody therapy
administered intravenously over 30 minutes.
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OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 6 Months to 24 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed acute lymphoblastic leukemia (ALL) or non-Hodgkin's lymphoma (including lymphoblastic lymphoma, Burkitt's lymphoma, and large cell lymphoma)
CD22 positive according to at least 1 of the following criteria:
No CNS leukemia or lymphoma as manifested by any of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Concurrent corticosteroids allowed provided there has been no increase in the dose 1 week prior to and after study entry
Radiotherapy
At least 3 weeks since prior radiotherapy
Surgery
Other
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
Bethesda, Maryland, United States, 20892-1182 |
Principal Investigator: | Alan S. Wayne, MD | NCI - Pediatric Oncology Branch |
Responsible Party: | MedImmune Inc. ( Karen Kaucic, M.D. ) |
Study ID Numbers: | CDR0000352020, NCI-04-C-0079H, NCI-5643 |
Study First Received: | February 10, 2004 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00077493 History of Changes |
Health Authority: | United States: Food and Drug Administration |
recurrent childhood acute lymphoblastic leukemia Burkitt lymphoma recurrent childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma childhood non-Hodgkin lymphoma |
Acute Lymphoblastic Leukemia, Childhood Leukemia, Lymphoid Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Immunologic Factors Lymphoblastic Lymphoma Immunotoxins Recurrence Antibodies, Monoclonal Lymphoma, Small Cleaved-cell, Diffuse Burkitt's Lymphoma |
Leukemia Lymphatic Diseases Antibodies Burkitt Lymphoma Lymphoma, Large-cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Acute Lymphoblastic Leukemia Immunoglobulins Non-Hodgkin Lymphoma, Childhood |
Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions Immunotoxins |
Antibodies, Monoclonal Leukemia Lymphatic Diseases Neoplasms Antibodies Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Immunoglobulins |