Methotrexate, Vincristine, Pegylated L-Asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage

NCT00905034 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2015-06-29

Study results available
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Summary

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 chronic myeloid leukemia (CML).

Conditions

  • Leukemia, Lymphocytic, Acute

Interventions

DRUG

Methotrexate

200 mg/m\^2 by vein on days 1 and 15.

DRUG

Vincristine

1.4 mg/m\^2 by vein (maximum dose 2 mg) on days 1, 8 and 15.

DRUG

PEG-l-asparaginase

2500 International units/m\^2 by vein on days 2 and 16

DRUG

Dexamethasone

40 mg by vein or by mouth daily days 1-4 and 15-18.

DRUG

Rituximab

Rituximab 375 mg/m\^2 by vein on days 1 and 15 (first 4 cycles) for patients CD20 positive or positive by immunostain.

Sponsors & Collaborators

  • Leadiant Biosciences, Inc.

    collaborator INDUSTRY
  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Gautam Borthakur, M.D. · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00905034 on ClinicalTrials.gov