Status:
COMPLETED
Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Leukemia
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if intensive chemotherapy (with monoclonal antibody therapy in some patients) given for 8 courses over 5 to 6 months followed by monthly maintenanc...
Detailed Description
The modified hyper-CVAD regimen is a combination of chemotherapy drugs including cyclophosphamide, vincristine, Adriamycin, dexamethasone and pegylated asparaginase given together for one "course" of ...
Eligibility Criteria
Inclusion
- Newly diagnosed, previously untreated Acute Lymphoblastic Leukemia (ALL) or lymphoblastic lymphoma, or having achieved Complete Remission (CR) with one course of induction chemotherapy.
- Failure to one induction course of chemotherapy are eligible, but these patients will be analyzed separately.
- All ages are eligible.
- Zubrod performance less than or equal to 3
- Adequate liver function (bilirubin \</= 3.0 mg/dl unless considered due to tumor) and renal function (creatinine \</= 3.0 mg/dl, unless considered due to tumor).
- Adequate cardiac function as assessed by history and physical examination.
- No active co-existing malignancy with life expectancy less than 12 months due to that malignancy.
Exclusion
- 1\) N/A
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00671658
Start Date
November 1 2002
End Date
July 1 2013
Last Update
December 3 2020
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030