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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Bristol-Myers Squibb |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00390793 |
The goal of this clinical research study is to find out if intensive chemotherapy combined with dasatinib, followed by maintenance therapy, can help to control ALL with the Ph chromosome and/or BCR-ABL. The safety of this treatment will also be studied.
Condition | Intervention | Phase |
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Acute Lymphoblastic Leukemia Leukemia |
Drug: Cyclophosphamide Drug: Vincristine Drug: Doxorubicin Drug: Dexamethasone Drug: Dasatinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Combination of Hyper-CVAD and Dasatinib in Patients With Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) |
Estimated Enrollment: | 70 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Hyper-CVAD + Dasatinib
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Drug: Cyclophosphamide
300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2 & 3
Drug: Vincristine
2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days
Drug: Doxorubicin
50 mg/m2 IV over 24 hours on day 4
Drug: Dexamethasone
40 mg IV or by mouth days 1-4 +/- 2 days and days 11-14 +/- 2 days
Drug: Dasatinib
50 mg by mouth twice daily days 1-14
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
History of significant bleeding disorder unrelated to cancer, including: · Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
Contact: Farhad Ravandi-Kashani, M.D. | 713-745-0394 | fravandi@mdanderson.org |
United States, Texas | |
The University of Texas M. D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 |
Principal Investigator: | Farhad Ravandi-Kashani, MD | M.D. Anderson Cancer Center |
Responsible Party: | The University of Texas M. D. Anderson Cancer Center ( Farhad Ravandi-Kashani, M.D./ Associate Professor ) |
Study ID Numbers: | 2006-0478 |
Study First Received: | October 18, 2006 |
Last Updated: | February 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00390793 History of Changes |
Health Authority: | United States: Institutional Review Board |
Acute Lymphocytic Leukemia Leukemia ALL Philadelphia-Positive ALL BCR-ABL Positive ALL Dasatinib Hyper-CVAD Cyclophosphamide Cytoxan |
Vincristine Vincasar Doxorubicin Adriamycin Dexamethasone Decadron Dasatinib Sprycel |
Anti-Inflammatory Agents Dexamethasone Leukemia, Lymphoid Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Cyclophosphamide Protein Kinase Inhibitors Hormones Anti-Bacterial Agents Leukemia Dasatinib Hyperkinesis Lymphoma |
Alkylating Agents Dexamethasone acetate Acute Lymphoblastic Leukemia Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Antineoplastic Agents, Hormonal Vincristine Antimitotic Agents Immunosuppressive Agents Glucocorticoids Doxorubicin Lymphatic Diseases Tubulin Modulators Antineoplastic Agents, Alkylating Peripheral Nervous System Agents |
Anti-Inflammatory Agents Dexamethasone Leukemia, Lymphoid Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Cyclophosphamide Antibiotics, Antineoplastic Protein Kinase Inhibitors Hormones Leukemia Dasatinib |
Therapeutic Uses Alkylating Agents Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Gastrointestinal Agents Vincristine Enzyme Inhibitors Antimitotic Agents Glucocorticoids Immunosuppressive Agents |