Study of Hyper-CVAD Plus Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038610
First received: June 3, 2002
Last updated: August 21, 2012
Last verified: August 2012
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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 2 |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Cyclophosphamide
Methotrexate
Cytarabine
Dexamethasone acetate
Vincristine sulfate
Dexamethasone sodium phosphate
Methotrexate sodium
Doxorubicin
Doxorubicin hydrochloride
Imatinib
Imatinib mesylate
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Number of Patients with Event-free survival after hyper-CVAD plus imatinib mesylate [ Time Frame: Baseline to 2 Years ] [ Designated as safety issue: Yes ]
| 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
Imatinib 600 mg by mouth. Cyclophosphamide 300 mg/m2. Doxorubicin 50 mg/m2. Vincristine 2 mg. Dexamethasone 40 mg. Methotrexate 200 mg/m2. Cytarabine 3 gm/m2.
|
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 |
Criteria
Inclusion Criteria:
- Diagnosis of previously untreated Ph-positive ALL or previously treated in CR after 1-2 courses of therapy or failure after one course of induction chemotherapy without imatinib mesylate.
- Age > or = 15 years. Those < 15 years of age will be treated under compassionate IND.
- Zubrod performance status < or = 2 (ECOG Scale, Appendix A).
- Adequate liver function (bilirubin < or = to 3.0 mg/dl, unless considered due to tumor), and renal function (creatinine < or = to 3.0 mg/dl, unless considered due to tumor).
- Adequate cardiac function as assessed clinically by physical examination.
- Signed informed consent.
Exclusion Criteria:
- Active serious infection not controlled by oral or intravenous antibiotics.
- Treatment with investigational antileukemic agent or chemotherapy agents in the last 7 days before study entry, unless full recovery from side-effects has occurred or patient has rapidly progressive disease judged life-threatening.
- Active secondary malignancy other than skin cancer (e.g. basal cell carcinoma or squamous cell carcinoma) than in investigator's opinion will shorten survival to less than 1 year.
- History of Grade III/IV cardiac problems as defined by the New York Heart Association Criteria.
- Prior history of treatment with imatinib mesylate.
- Pregnancy or lactating in women of childbearing potential.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038610
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Naval Daver, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| 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: | August 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Leukemia, Lymphoblastic, Acute, Philadelphia-Positive |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on June 18, 2013