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

NCT00905034 | Completed Phase 2 Results

• 2 other identifiers: 2008-0267NCI-2010-01147
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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).

Conditions

Leukemia, Lymphocytic, Acute

Keywords

Acute lymphoblastic leukemia; ALL; Leukemia; Methotrexate; Vincristine; PEG-l-asparaginase; PEG asparaginase; Pegaspargase; Oncaspar; Polyethylene Glycol Conjugated Lasparaginase-H; Dexamethasone; Decadron; Rituximab; Rituxan

Outcome Measures

Primary Outcomes (1)

• Complete Response (CR) Rate

  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.

  6 cycles (cycle = 28 days)

Study Arms (1)

MOAD

EXPERIMENTAL

Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD).

Drug: Methotrexate; Drug: Vincristine; Drug: PEG-l-asparaginase; Drug: Dexamethasone; Drug: Rituximab

Interventions

Methotrexate DRUG

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

Also known as: Rheumatrex

MOAD

Vincristine DRUG

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

Also known as: Oncovin®

MOAD

PEG-l-asparaginase DRUG

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

Also known as: Oncaspar®, PEG asparaginase, Pegaspargase, Polyethylene Glycol Conjugated Lasparaginase-H

MOAD

Dexamethasone DRUG

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

Also known as: Decadron®

MOAD

Rituximab DRUG

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

Also known as: Rituxan®

MOAD

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Chronic myeloid leukemia in blast phase
• Zubrod performance status \</= 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;
• Age \>/= to 1 year
• Understand and voluntarily sign an informed consent form.
• For pediatric patients (age \>/= 1 year to \</= 18 years), Lansky performance status \>/=50
• For pediatric patients (age \>/= 1 year to \</= 18 years), second or greater relapse

You may not qualify if:

• Pregnant patients
• Prior history of allergic reaction, serious pancreatitis, hemorrhagic or thrombotic event with PEG-l-asparaginase or its components.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Leadiant Biosciences, Inc.: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia

Interventions

Methotrexate; Vincristine; pegaspargase; Dexamethasone; Calcium Dobesilate; Rituximab

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Gautam Borthakur, MD/Associate Professor, Leukemia
• Organization: University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-563-1586

Study Officials

• Gautam Borthakur, M.D.

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 20, 2009
• Study Start: March 1, 2009
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 29, 2015
• Results First Posted: June 29, 2015

Record last verified: 2015-06

Locations

US (1)