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

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ClinicalTrials.gov Identifier: NCT00905034
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : June 29, 2015
Last Update Posted : June 29, 2015
Sponsor:
Collaborator:
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

  Show Detailed Description

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
Primary Completion Date : February 2015
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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT00905034


Locations
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.
Investigators
Principal Investigator: Gautam Borthakur, M.D. M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov 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
ALL
Leukemia
Methotrexate
Vincristine
PEG-l-asparaginase
PEG asparaginase
Pegaspargase
Oncaspar
Polyethylene Glycol Conjugated Lasparaginase-H
Dexamethasone
Decadron
Rituximab
Rituxan

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Pegaspargase
Rituximab
Methotrexate
Vincristine
Asparaginase
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors