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Study Summary
No. 2006-0328:.......Leukemia......Stefan Faderl......Leukemia
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Study Summary Title
Study Summary
Number:		2006-0328
Study Title:Phase II Study of Hyper-CVAD plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma
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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:713-745-4613
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		Every one to 3 months as long as receiving active therapy. Thereafter every 3
to 6 months as long as on study.
Treatment
Agents:		Adriamycin
Asparaginase
Compound 506
Cyclophosphamide
Cytarabine
Decadron
Mercaptopurine
Methotrexate
Prednisone
Vincristine		Home Care:All chemotherapy (except course 1 and drug administration phase of course 2)
and follow up may be provided for at home
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		Minimum of 21 days during the first course, and at least 5 days during the
second course.
Description/
Intervention:		The goal of this clinical research study is to learn the effectiveness of
intensive chemotherapy given in combination with nelarabine (followed by
maintenance therapy) in the treatment of patients with T cel ALL and T cell
lymphoblastic lymphoma. The safety of this treatment will also be studied.
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Study Objectives / Outcomes
1. To determine the complete remission (CR) rate and progression-free survival following treatment with hyper-CVAD in combination with nelarabine in previously untreated patients with T-cell ALL and T-cell lymphoblastic lymphoma.

2. To determine the safety and overall survival of previously untreated patients with T-cell ALL and T-cell lymphoblastic lymphoma.
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Study Status Information
Study Activation / Registration Date:07/11/2007
IRB Review and Approval Date:08/22/2006
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
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 untreated T cell ALL including T cell lymphoblastic lymphoma. Failure to one induction course of chemotherapy are eligible. Patients in CR after </= 2 courses are also eligible.

2) ECOG performance status less than or equal to 3.

3) Serum bilirubin less than or equal to 2.0 mg/dL unless considered due to involvement by tumor when an upper limit of 5.0 mg/dL is acceptable. SGOT or SGPT less than or equal to 4 x ULN.

4) Serum creatinine less than or equal to 2.0 mg/dL unless considered due to involvement by tumor when an upper limit of 2.5 mg/dL is acceptable.
Exclusion Criteria:1) Pregnant or nursing women
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Links
Registration Number: NCT00501826
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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