MDACC Study Summary 2008-0267

Study Summary
No. 2008-0267:.......Leukemia......Gautam Borthakur......Leukemia

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

Physician

New Patient Referral



Name:	Gautam Borthakur	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Leukemia	Referring 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

General Information



Disease Group:	Leukemia	Supported By:	Enzon Pharmaceuticals, Inc.

Phase of Study:	Phase II	Return 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.

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.

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:	Open

Projected Accrual:	N/A

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;

2) Zubrod performance status </= 3;

3) 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;

4) Age >/= to 1 year

5) Understand and voluntarily sign an informed consent form.

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

7) 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.

Links

Registration Number: NCT00905034
Study Information on Clinical Trials Registry (clinicaltrials.gov)