Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00061945
First received: June 5, 2003
Last updated: January 25, 2013
Last verified: January 2013
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Purpose
This phase I/II trial studies the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with untreated acute lymphoblastic leukemia. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy also work in different ways to kill cancer cells or stop them from growing. Giving alemtuzumab together with combination chemotherapy may be a better way to block cancer growth
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Undifferentiated Leukemia B-cell Adult Acute Lymphoblastic Leukemia B-cell Childhood Acute Lymphoblastic Leukemia L1 Adult Acute Lymphoblastic Leukemia L1 Childhood Acute Lymphoblastic Leukemia L2 Adult Acute Lymphoblastic Leukemia L2 Childhood Acute Lymphoblastic Leukemia Philadelphia Chromosome Negative Adult Precursor Acute Lymphoblastic Leukemia Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia Philadelphia Chromosome Positive Childhood Precursor Acute Lymphoblastic Leukemia T-cell Adult Acute Lymphoblastic Leukemia T-cell Childhood Acute Lymphoblastic Leukemia Untreated Adult Acute Lymphoblastic Leukemia Untreated Childhood Acute Lymphoblastic Leukemia |
Drug: allopurinol Drug: cyclophosphamide Drug: daunorubicin hydrochloride Drug: vincristine sulfate Drug: dexamethasone Drug: asparaginase Biological: filgrastim Drug: imatinib mesylate Drug: methotrexate Drug: cytarabine Drug: trimethoprim-sulfamethoxazole Drug: mercaptopurine Drug: leucovorin calcium Biological: alemtuzumab Drug: acyclovir Other: laboratory biomarker analysis Other: pharmacological study |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial acute myeloid leukemia with mutated CEBPA
tetrasomy 18p
Drug Information available for:
Dexamethasone
Cyclophosphamide
Mercaptopurine
Methotrexate
Cytarabine
Allopurinol
Sulfamethoxazole
Trimethoprim
Dexamethasone acetate
Leucovorin calcium
Vincristine sulfate
Dexamethasone sodium phosphate
Asparaginase
Sulfate ion
Methotrexate sodium
Allopurinol sodium
Daunorubicin
Daunorubicin hydrochloride
Acyclovir
Trimethoprim hydrochloride
Levoleucovorin
Acyclovir sodium
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
Imatinib
Alemtuzumab
Imatinib mesylate
Daunorubicin citrate
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Maximum tolerated dose (MTD) of alemtuzumab defined as the highest dose at which less than 40% of patients develop the dose-limiting toxicity (DLT) assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Phase I) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- At least 80% of patients entering course 4 (module D) are able to start course 5 (module A) of treatment (Phase II) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity profile of alemtuzumab assessed using CTCAE version 3.0 (Phase II) [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]Toxicities will be tabulated by type and grade.
- Modulation of minimal residual disease during treatment with alemtuzumab (Phase II) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
- Disease-free survival (Phase II) [ Time Frame: 3 years ] [ Designated as safety issue: No ]Will be estimated using the Kaplan-Meier method with confidence intervals presented.
- Overall survival (Phase II) [ Time Frame: 3 years ] [ Designated as safety issue: No ]Will be estimated using the Kaplan-Meier method with confidence intervals presented.
| Enrollment: | 71 |
| Study Start Date: | June 2003 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (alemtuzumab and combination chemotherapy)
See detailed description.
|
Drug: allopurinol
Given PO
Other Names:
Drug: cyclophosphamide
Given IV
Other Names:
Drug: daunorubicin hydrochloride
Given IV
Other Names:
Drug: vincristine sulfate
Given IV
Other Names:
Drug: dexamethasone
Given PO and as eye drops
Other Names:
Drug: asparaginase
Given SC
Other Names:
Biological: filgrastim
Given SC
Other Names:
Drug: imatinib mesylate
Given PO
Other Names:
Drug: methotrexate
Given IT, IV, and PO
Other Names:
Drug: cytarabine
Given IV
Other Names:
Drug: trimethoprim-sulfamethoxazole
Given PO
Other Names:
Drug: mercaptopurine
Given PO
Other Names:
Drug: leucovorin calcium
Given IV and PO
Other Names:
Biological: alemtuzumab
Given SC
Other Names:
Drug: acyclovir
Given PO
Other Names:
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Unequivocal histologic diagnosis of precursor B or precursor T lymphoblastic leukemia (World Health Organization [WHO] classification), L1 or L2 ALL or acute undifferentiated leukemia (AUL) (French-American-British Cooperative group [FAB] Classification); Burkitt-type ALL (FAB L3, surface immunoglobulin [SIg]+) are excluded
No prior treatment for leukemia with three permissible exceptions:
- Emergency leukapheresis II. Emergency treatment for hyperleukocytosis with hydroxyurea III. Cranial radiation therapy (RT) for central nervous system (CNS) leukostasis (one dose only)
- All patients must have a pre-treatment bone marrow or peripheral blood sample submitted for central immunophenotyping; only those patients who express CD52 >= 10% in the leukemia blast cell channel will be eligible to receive Campath-1H during module D, course IV
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00061945
Locations
| United States, Illinois | |
| University of Chicago Comprehensive Cancer Center | |
| Chicago, Illinois, United States, 60637-1470 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Wendy Stock | Cancer and Leukemia Group B (CALGB) Research Base |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00061945 History of Changes |
| Other Study ID Numbers: | NCI-2012-02807, CALGB 10102, U10CA031946, CDR0000302482 |
| Study First Received: | June 5, 2003 |
| Last Updated: | January 25, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Philadelphia Chromosome Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Translocation, Genetic Chromosome Aberrations Pathologic Processes Leukemia, Myeloid |
6-Mercaptopurine Allopurinol Cytarabine Methotrexate Cyclophosphamide Campath 1G Alemtuzumab Imatinib Asparaginase Daunorubicin Dexamethasone Vincristine BB 1101 Trimethoprim Antibodies |
ClinicalTrials.gov processed this record on May 23, 2013