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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sigma Tau Pharmaceuticals, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00905034
First received: May 18, 2009
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Complete Response (CR) Rate [ Time Frame: 6 cycles (cycle = 28 days) ] [ Designated as safety issue: Yes ]
    Complete Remission (CR): 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 109/L or above and platelet count of 100 x 109/L or above. Complete resolution of all sites of extramedullary disease is required for CR.


Estimated Enrollment: 60
Study Start Date: May 2009
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Sigma Tau Pharmaceuticals, Inc.
Investigators
Principal Investigator: Gautam Borthakur, M.D. M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00905034     History of Changes
Other Study ID Numbers: 2008-0267, NCI-2010-01147
Study First Received: May 18, 2009
Last Updated: September 11, 2014
Health Authority: United States: Institutional Review Board

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:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Rituximab
Pegaspargase
Methotrexate
Vincristine
Asparaginase
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 22, 2014