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Study Summary
No. ID03-0166:.......Leukemia......Stefan Faderl......Leukemia
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Study Summary Title
Study Summary
Number:		ID03-0166
Study Title:Phase II Study of Augmented Hyper-CVAD in Acute Lymphoblastic Leukemia Salvage
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Physician New Patient Referral
Name:Stefan FaderlPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-7026
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		Induction chemotherapy must be given at MDACC. Visits every 2-3 courses.
Treatment
Agents:		ARA-C
Cyclophosphamide
Decadron
Doxorubicin
G-CSF
Mesna
Methotrexate
Vincristine		Home Care:Intensive chemotherapy courses will be prescribed by M.D. Anderson physician or
Principal Investigator. All chemotherapy treatment may be given by local
oncologist except for the induction chemotherapy course.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		4 to 5 days for chemotherapy every 3 to 4 weeks.
Description/
Intervention:		The goal of this clinical research study is to learn if a special combination
of chemotherapy drugs called "augmented hyper-CVAD chemotherapy" given over 6
to 8 months followed by monthly maintenance chemotherapy for one year can help
to control acute lymphoblastic leukemia or lymphoblastic lymphoma. The safety
of this therapy will also be studied.
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Study Objectives / Outcomes
Primary endpoints:
  • Complete remission rate
  • Mortality and toxicity rate

Secondary endpoint:
  • Disease-free survival (DFS)
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Study Status Information
Study Activation / Registration Date:06/09/2003
IRB Review and Approval Date:05/21/2003
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Previously treated ALL (including Burkitt's lymphoma) or lymphoblastic lymphoma in relapse or primary refractory;

2) No age restrictions;

3) Zubrod performance status </= 3;

4) Adequate liver (bilirubin </= 3mg/dl unless considered due to tumor) and renal function (creatinine </= 3mg/dl unless considered due to tumor);

5) Adequate cardiac function (NYHA < III as assessed by history and physical examination)
Exclusion Criteria:N/A
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Links
Registration Number: NCT00890656
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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