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Study Summary
No. 2008-0267:.......Leukemia......Gautam Borthakur......Leukemia
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Study Summary Title
Study Summary
Number:		2008-0267
Study Title:Phase II study of methotrexate, vincristine, pegylated L-asparaginase and dexamethasone (MOAD) in acute lymphoblastic leukemia (ALL) salvage and Chronic Myeloid Leukemia (CML) in blast phase
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Physician New Patient Referral
Name:Gautam BorthakurPatients 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:713-563-1586
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:Sigma-Tau Pharmaceuticals, Inc.
Phase of Study:Phase IIReturn
Visit:		minimum of one time a week for the first two weeks; 1-3 months thereafter.
Treatment
Agents:		Dexamethasone
Methotrexate
PEG-L-Asparaginase
Rituximab
Vincristine		Home Care:Treatment beyond first two weeks can be received by local oncologist.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		not applicable
Description/
Intervention:		This goal of this clinical research study is to learn if the combination of
methotrexate, pegylated-L-asparaginase, vincristine, and dexamethasone (also
rituximab in some patients) can help to control ALL that has not responded to
previous treatment or has come back after a response or CML.
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Study Objectives / Outcomes
To determine the efficacy and safety of a chemotherapy regimen comprising of methotrexate, vincristine, pegylated L-asparaginase and dexamethasone in acute lymphoblastic leukemia (ALL) salvage or chronic myeloid leukemia (CML) in blast phase.
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Study Status Information
Study Activation / Registration Date:03/06/2009
IRB Review and Approval Date:03/06/2009
Study Type:Phase Ii Or Phase I/Ii
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; without viable stem cell transplant option. Patients with previously treated Philadelphia chromosome positive ALL will be also eligible;

2) Chronic myeloid leukemia in blast phase

3) Zubrod performance status </= 3;

4) Adequate liver function (bilirubin </= 3.0mg/dl, unless considered due to tumor),and renal function (creatinine </= 3.0 mg/dl unless considered due to tumor;

5) Age >/= to 1 year

6) Understand and voluntarily sign an informed consent form.

7) For pediatric patients (age >/= 1 year to </= 18 years), Lansky performance status >/=50

8) For pediatric patients (age >/= 1 year to </= 18 years), second or greater relapse
Exclusion Criteria:1) Pregnant patients

2) Prior history of allergic reaction, serious pancreatitis, hemorrhagic or thrombotic event with PEG-l-asparaginase or its components.
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Links
Registration Number: NCT00905034
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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