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| Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00061945 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of alemtuzumab and to see how well it works when given together with combination chemotherapy in patients with previously untreated acute lymphoblastic leukemia.
| Condition | Intervention | Phase |
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Leukemia |
Drug: alemtuzumab Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: filgrastim Drug: imatinib mesylate Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: vincristine sulfate |
Phase I Phase II |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I/II Dose Escalation Study of Subcutaneous Campath-1H (NSC #715969, IND #10864) During Intensification Therapy in Adults With Untreated Acute Lymphoblastic Leukemia (ALL) |
| Estimated Enrollment: | 282 |
| Study Start Date: | June 2003 |
| Estimated Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No prior treatment for leukemia except for any of the following:
Must have a pretreatment bone marrow or peripheral blood sample submitted for central immunophenotyping
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
No concurrent palliative radiotherapy
Surgery
Other
Contacts and Locations |
Show 35 Study Locations |
| Cancer and Leukemia Group B |
| National Cancer Institute (NCI) |
| Study Chair: | Wendy Stock, MD | University of Chicago |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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Lozanski G, Sanford B, Mrozek K, et al.: Quantitative measurement of CD52 expression and alemtuzumab binding in adult acute lymphoblastic leukemia (ALL): correlation with immunophenotype and cytogenetics in patients (pts) enrolled on a phase I/II trial from the Cancer and Leukemia Group B (CALGB 10102). [Abstract] Blood 110 (11): A-2386, 2007.
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Stock W, Yu D, Sanford B, et al.: Incorporation of alemtuzumab into front-line therapy of adult acute lymphoblastic leukemia (ALL) is feasible: a phase I/II study from the Cancer and Leukemia Group B (CALGB 10102). [Abstract] Blood 106 (11): A-145, 2005.
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| Study ID Numbers: | CDR0000302482, CALGB-10102 |
| First Received: | June 5, 2003 |
| Last Updated: | August 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00061945 |
| Health Authority: | United States: Food and Drug Administration |
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