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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00038610 |
Purpose
The goal of this clinical research study is to learn if intensive chemotherapy, combined with imatinib mesylate (Gleevec, STI571) given for 8 courses over 6 months, followed by maintenance imatinib mesylate plus chemotherapy for 2 years, followed by imatinib mesylate indefinitely can improve Philadelphia-positive acute lymphoblastic leukemia. The safety of this treatment will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia, Lymphocytic, Acute, L2 |
Drug: Imatinib Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Dexamethasone Drug: Methotrexate Drug: Cytarabine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Hyper-CVAD Plus Imatinib Mesylate (Gleevec, STI571) for Philadelphia-Positive Acute Lymphocytic Leukemia |
| Estimated Enrollment: | 55 |
| Study Start Date: | March 2001 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Hyper-CVAD + Imatinib |
Drug: Imatinib
Imatinib 600mg PO
Other Name: Gleevec
Drug: Cyclophosphamide
Cyclophosphamide 300mg/m2
Other Names:
Drug: Doxorubicin
Doxorubicin 50mg/m2
Other Names:
Drug: Vincristine
Vincristine 2mg
Other Name: Oncovin ®, Vincasar Pfs ®
Drug: Dexamethasone
Dexamethasone 40mg
Other Name: Decadron
Drug: Methotrexate
Methotrexate 200mg/m2
Other Name: Rheumatrex®, TrexallTM
Drug: Cytarabine
Cytarabine 3gm/m2
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Susan O'Brien, M.D. | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00038610 History of Changes |
| Other Study ID Numbers: | ID01-006 |
| Study First Received: | June 3, 2002 |
| Last Updated: | February 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Leukemia, Lymphoblastic, Acute, Philadelphia-Positive |
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Cytarabine Methotrexate Imatinib Dexamethasone Doxorubicin |
Vincristine Dexamethasone acetate Dexamethasone 21-phosphate BB 1101 Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |