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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center Novartis |
| Information provided by: | 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 |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase II Study of Hyper-CVAD Plus Imatinib Mesylate (Gleevec, STI571) for Philadelphia-Positive Acute Lymphocytic Leukemia |
| Enrollment: | 54 |
| Study Start Date: | March 2001 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
Hyper-CVAD + Imatinib
|
Drug: Imatinib
Imatinib 600mg PO
Drug: Cyclophosphamide
Cyclophosphamide 300mg/m2
Drug: Doxorubicin
Doxorubicin 50mg/m2
Drug: Vincristine
Vincristine 2mg
Drug: Dexamethasone
Dexamethasone 40mg
Drug: Methotrexate
Methotrexate 200mg/m2
Drug: Cytarabine
Cytarabine 3gm/m2
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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 |
Inclusion:
Exclusion:
Contacts and Locations| United States, Texas | |||||
| MD Anderson Cancer Center | |||||
| Houston, Texas, United States, 77030 | |||||
| M.D. Anderson Cancer Center |
| Novartis |
| Principal Investigator: | Susan O'Brien, M.D. | M.D. Anderson Cancer Center |
More Information
M.D. Anderson's website 
  |
| Responsible Party: | University of Texas - MD Anderson Cancer Center ( Susan O'Brien, MD, BA, Professor ) |
| Study ID Numbers: | ID01-006 |
| First Received: | June 3, 2002 |
| Last Updated: | July 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00038610 |
| Health Authority: | United States: Food and Drug Administration |
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