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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Bristol-Myers Squibb |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00390793 |
Purpose
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 |
|---|---|---|
|
Acute Lymphoblastic Leukemia Leukemia |
Drug: Cyclophosphamide Drug: Vincristine Drug: Doxorubicin Drug: Dexamethasone Drug: Dasatinib Drug: Methotrexate Drug: Ara-C |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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: | 115 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Hyper-CVAD + Dasatinib
Odd-numbered courses (1, 3, 5, and 7), Cyclophosphamide IV Days 1-3, every 12 hours for 6 doses with MESNA CVC over 24 hours until 12 hours after last dose cyclophosphamide; Vincristine IV Days 4 and 11, over 30 minutes during hyper-CVAD therapy; Doxorubicin CVC Day 4 over 24-48 hours after last dose of Cyclophosphamide; Dexamethasone Days 1-4 & Days 11-14 PO or IV over 30 minutes during hyper-CVAD therapy.
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Drug: Cyclophosphamide
300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2 & 3
Other Name: Cytoxan
Drug: Vincristine
2 mg IV on day 4 +/- 2 days and day 11 +/- 2 days
Other Name: Vincasar
Drug: Doxorubicin
50 mg/m^2 IV over 24 hours on day 4
Other Name: Adriamycin
Drug: Dexamethasone
40 mg IV or by mouth days 1-4 +/- 2 days and days 11-14 +/- 2 days
Other Name: Decadron
Drug: Dasatinib
100 mg by mouth (PO) daily on days 1-14; 70 mg PO daily continuously for Course 2 - 8.
Other Name: Sprycel
Drug: Ara-C
3 g/m^2 IV over 2 hours every 12 hours for 4 doses on days 2, 3.
Other Names:
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Experimental: Methotrexate + Ara-C
Even-numbered courses (2, 4, 6, and 8), Methotrexate IV Day 1; Ara-C IV Days 2 and 3 (over 2 hours every 12 hours for total of 4 doses each time)
|
Drug: Dasatinib
100 mg by mouth (PO) daily on days 1-14; 70 mg PO daily continuously for Course 2 - 8.
Other Name: Sprycel
Drug: Methotrexate
200 mg/m^2 over 2 hours followed by 800 mg/m^2 over 22 hours on day 1.
Drug: Ara-C
3 g/m^2 IV over 2 hours every 12 hours for 4 doses on days 2, 3.
Other Names:
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Farhad Ravandi-Kashani, M.D. | 713-745-0394 | fravandi@mdanderson.org |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Farhad Ravandi-Kashani, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00390793 History of Changes |
| Other Study ID Numbers: | 2006-0478 |
| Study First Received: | October 18, 2006 |
| Last Updated: | November 30, 2011 |
| Health Authority: | United States: Institutional Review Board |
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Acute Lymphocytic Leukemia Leukemia ALL Philadelphia-Positive ALL BCR-ABL Positive ALL Dasatinib Hyper-CVAD Cyclophosphamide |
Cytoxan Vincristine Vincasar Doxorubicin Adriamycin Dexamethasone Decadron Sprycel |
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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 Dexamethasone Doxorubicin Vincristine |
Dexamethasone acetate Dexamethasone 21-phosphate BB 1101 Dasatinib 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 |