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Trial record 16 of 325 for:    "Acute Lymphocytic Leukemia" | "Methotrexate"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00905034
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : June 29, 2015
Last Update Posted : June 29, 2015
Leadiant Biosciences, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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).

Condition or disease Intervention/treatment Phase
Leukemia, Lymphocytic, Acute Drug: Methotrexate Drug: Vincristine Drug: PEG-l-asparaginase Drug: Dexamethasone Drug: Rituximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Methotrexate, Vincristine, Pegylated L-asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage
Study Start Date : March 2009
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Arm Intervention/treatment
Experimental: MOAD
Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD).
Drug: Methotrexate
200 mg/m^2 by vein on days 1 and 15.
Other Name: Rheumatrex

Drug: Vincristine
1.4 mg/m^2 by vein (maximum dose 2 mg) on days 1, 8 and 15.
Other Name: Oncovin®

Drug: PEG-l-asparaginase
2500 International units/m^2 by vein on days 2 and 16
Other Names:
  • Oncaspar®
  • PEG asparaginase
  • Pegaspargase
  • Polyethylene Glycol Conjugated Lasparaginase-H

Drug: Dexamethasone
40 mg by vein or by mouth daily days 1-4 and 15-18.
Other Name: Decadron®

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.
Other Name: Rituxan®

Primary Outcome Measures :
  1. Complete Response (CR) Rate [ Time Frame: 6 cycles (cycle = 28 days) ]
    Rate calculated as number of participants with CR. Complete Remission (CR) defined as Normalization of peripheral blood and bone marrow with 5% or less blasts in a normocellular or hypercellular marrow with a granulocyte count of 1 x 10^9/L or above and platelet count of 100 x 10^9/L or above. Complete resolution of all sites of extramedullary disease is required for CR.

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00905034

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Leadiant Biosciences, Inc.
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Principal Investigator: Gautam Borthakur, M.D. M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00905034     History of Changes
Other Study ID Numbers: 2008-0267
NCI-2010-01147 ( Registry Identifier: NCI CTRP )
First Posted: May 20, 2009    Key Record Dates
Results First Posted: June 29, 2015
Last Update Posted: June 29, 2015
Last Verified: June 2015
Keywords provided by M.D. Anderson Cancer Center:
Acute lymphoblastic leukemia
PEG asparaginase
Polyethylene Glycol Conjugated Lasparaginase-H
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors