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Tracking Information | |||||
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First Received Date † | February 10, 2004 | ||||
Last Updated Date | December 21, 2007 | ||||
Start Date † | January 2004 | ||||
Current Primary Outcome Measures † |
assessment of efficacy, safety, pharmacokinetics, immunogenicity. [ Time Frame: end of study ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00077493 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Expansion of MTD [ Time Frame: end of study ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | BL22 Immunotoxin In Treating Young Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma | ||||
Official Title † | Pediatric Phase I Trial of BL22 for Refractory CD22-Positive Leukemias and Lymphomas | ||||
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. |
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Detailed Description | 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. |
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Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study | ||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Suspended | ||||
Estimated Enrollment † | 95 | ||||
Estimated Completion Date | October 2008 | ||||
Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||
Ages | 6 Months to 24 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00077493 | ||||
Responsible Party | Karen Kaucic, M.D., MedImmune Inc. | ||||
Secondary IDs †† | NCI-04-C-0079H, NCI-5643 | ||||
Study Sponsor † | MedImmune LLC | ||||
Collaborators †† | Cambridge Antibody Technology | ||||
Investigators † |
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Information Provided By | MedImmune LLC | ||||
Verification Date | December 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |