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

Sponsor:	M.D. Anderson Cancer Center
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00905034

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.

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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:

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Dexamethasone Vincristine Methotrexate Ethanol, 2,2'-(oxybis(2,1-ethanediyloxy)bis- Dexamethasone acetate Doxiproct plus Pegaspargase Rituximab Dexamethasone Sodium Phosphate Vincristine sulfate L-Asparaginase

U.S. FDA Resources

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

Primary Outcome Measures:

Complete Response (CR) Rate Defined as Number of Participants Who Achieve a Complete Response [ Time Frame: 6 cycles (cycle = 28 days) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	May 2009
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MOAD Chemotherapy regimen of methotrexate, 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®

Arms

Assigned Interventions

Experimental: MOAD

Chemotherapy regimen of methotrexate, 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:

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;
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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905034

Contacts

Contact: Gautam Borthakur, M.D.

713/563-1586

gborthak@mdanderson.org

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Gautam Borthakur, M.D. 713-563-1586 gborthak@mdanderson.org
Principal Investigator: Gautam Borthakur, M.D.

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Gautam Borthakur, M.D.

M.D. Anderson Cancer Center

More Information

Additional Information:

M.D. Anderson's Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00905034 History of Changes
Other Study ID Numbers:	2008-0267
Study First Received:	May 18, 2009
Last Updated:	January 3, 2012
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:

Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pegaspargase
Rituximab
Asparaginase
Dexamethasone
Methotrexate
Vincristine

Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on February 09, 2012