SWOG-9400 Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Previously Untreated Acute Lymphocytic Leukemia

March 5, 2015 updated by: Southwest Oncology Group

TREATMENT OF ADULT ACUTE LYMPHOBLASTIC LEUKEMIA: PHASE II TRIALS OF AN INDUCTION REGIMEN INCLUDING PEG-L-ASPARAGINASE, WITH OR WITHOUT PIXY, IN PREVIOUSLY UNTREATED PATIENTS, FOLLOWED BY ALLOGENEIC BONE MARROW TRANSPLANTATION OR FURTHER CHEMOTHERAPY IN FIRST COMPLETE REMISSION

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with or without bone marrow transplantation in treating patients who have acute lymphocytic leukemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Evaluate if front line induction therapy with daunorubicin, vincristine, prednisone, and asparaginase is sufficiently effective to warrant a phase III trial in patients with acute lymphocytic leukemia (ALL). II. Assess the toxicity of this regimen in this patient population. III. Assess disease free and overall survival and toxicity associated with allogeneic bone marrow transplantation for ALL patients in first remission following induction and consolidation therapy. IV. Assess disease free and overall survival and toxicity associated with sequential regimens of mercaptopurine, methotrexate and vincristine, doxorubicin, dexamethasone, and cyclophosphamide, thioguanine, and cytarabine in ALL patients in first remission who are ineligible for allogeneic bone marrow transplantation. V. Evaluate the prognostic significance of cell surface immunophenotype, Philadelphia chromosome, and polymerase chain reaction detected BCR/abl fusion in this patient population.

OUTLINE: Patients are stratified according to age (15 to 29 vs 30 to 49 vs 50 to 65), performance status (0-1 vs 2-3), participating center, and candidate for allogeneic bone marrow transplantation (yes vs no). Patients receive induction chemotherapy consisting of daunorubicin IV on days 1-3, vincristine IV on days 1, 8, 15, and 22, oral prednisone on days 1-28, and asparaginase IV or intramuscularly (IM) on days 15-24. Patients with persistent leukemia on day 21, receive additional induction therapy consisting of daunorubicin IV on days 22 and 23, vincristine IV on days 29 and 36, and oral prednisone continuing to day 42. Patients with CNS leukemia receive additional therapy beginning on day 1 of induction chemotherapy consisting of methotrexate intrathecally (IT) or intraventricularly twice weekly until blasts are absent in spinal fluid. Patients receive oral leucovorin calcium every 6 hours for a total of 4 doses following each IT dose in the absence of blood count recovery. Following absence of spinal fluid blasts, patients receive methotrexate IT or intraventricularly weekly for 4 weeks then monthly for 1 year. Patients also receive cranial radiotherapy during consolidation therapy 5 days a week for 2.5 weeks. Patients with A1 bone marrow receive consolidation therapy following completion of induction therapy and blood count recovery. Patients receive consolidation therapy consisting of cyclophosphamide IV on days 1, 15, and 29, cytarabine IV on days 2-5, 9-12, 16-19, and 23-26, oral mercaptopurine on days 1-28, and methotrexate IT on days 2, 9, 16, and 23. Following completion of consolidation therapy, patients eligible for allogeneic bone marrow transplantation receive total body radiotherapy 3 times a day on days -7, -6, -5, and twice on day -4, and eptoposide IV over 4 hours on day -3. Patients undergo allogeneic bone marrow transplantation on day 0. Following completion of consolidation therapy, patients ineligible for allogeneic bone marrow transplantation receive maintenance therapy consisting of oral mercaptopurine on days 1-63, and oral methotrexate on days 1, 8, 15, 22, 29, 36, 43, 50, and 57. Patients receive subsequent courses of maintenance therapy when blood counts recover. Patients receive a second course of maintenance therapy consisting of vincristine IV on days 1, 8, 15, and 22, doxorubicin IV on days 1, 8, 15, and 22, and oral dexamethasone on days 1-28. Patients receive a third course consisting of cyclophosphamide IV on day 1, oral thioguanine on days 1-14, and cytarabine IV on days 3-6 and 10-13. Patients receive a fourth course consisting of oral mercaptopurine and oral methotrexate daily for 2 years. Patients are followed monthly for 6 months and then every 2 months thereafter.

PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36688
        • MBCCOP - University of South Alabama
    • Arizona
      • Phoenix, Arizona, United States, 85006-2726
        • CCOP - Greater Phoenix
      • Phoenix, Arizona, United States, 85012
        • Veterans Affairs Medical Center - Phoenix (Hayden)
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center
      • Tucson, Arizona, United States, 85723
        • Veterans Affairs Medical Center - Tucson
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, United States, 72205
        • Veterans Affairs Medical Center - Little Rock (McClellan)
    • California
      • Duarte, California, United States, 91010
        • Beckman Research Institute, City of Hope
      • Long Beach, California, United States, 90822
        • Veterans Affairs Medical Center - Long Beach
      • Los Angeles, California, United States, 90033-0800
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Martinez, California, United States, 94553
        • Veterans Affairs Outpatient Clinic - Martinez
      • Oakland, California, United States, 94609-3305
        • CCOP - Bay Area Tumor Institute
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center
      • Santa Rosa, California, United States, 95403
        • CCOP - Santa Rosa Memorial Hospital
      • Travis Air Force Base, California, United States, 94535
        • David Grant Medical Center
    • Colorado
      • Denver, Colorado, United States, 80220
        • Veterans Affairs Medical Center - Denver
      • Denver, Colorado, United States, 80262
        • University of Colorado Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30342-1701
        • CCOP - Atlanta Regional
      • Fort Gordon, Georgia, United States, 30905-5650
        • Dwight David Eisenhower Army Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Cancer Research Center of Hawaii
    • Illinois
      • Hines, Illinois, United States, 60141
        • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Springfield, Illinois, United States, 62526
        • CCOP - Central Illinois
    • Kansas
      • Kansas City, Kansas, United States, 66160-7357
        • University of Kansas Medical Center
      • Wichita, Kansas, United States, 67214-3882
        • CCOP - Wichita
      • Wichita, Kansas, United States, 67218
        • Veterans Affairs Medical Center - Wichita
    • Kentucky
      • Lexington, Kentucky, United States, 40511-1093
        • Veterans Affairs Medical Center - Lexington
      • Lexington, Kentucky, United States, 40536-0084
        • Albert B. Chandler Medical Center, University of Kentucky
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine
      • New Orleans, Louisiana, United States, 70112
        • MBCCOP - LSU Medical Center
      • New Orleans, Louisiana, United States, 70112
        • Veterans Affairs Medical Center - New Orleans
      • Shreveport, Louisiana, United States, 71130
        • Veterans Affairs Medical Center - Shreveport
      • Shreveport, Louisiana, United States, 71130-3932
        • Louisiana State University Hospital - Shreveport
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Jamaica Plain, Massachusetts, United States, 02130
        • Veterans Affairs Medical Center - Boston (Jamaica Plain)
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0752
        • University of Michigan Comprehensive Cancer Center
      • Ann Arbor, Michigan, United States, 48105
        • Veterans Affairs Medical Center - Ann Arbor
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48201-1932
        • Veterans Affairs Medical Center - Detroit
      • Grand Rapids, Michigan, United States, 49503
        • CCOP - Grand Rapids Clinical Oncology Program
      • Southfield, Michigan, United States, 48075-9975
        • Providence Hospital - Southfield
    • Mississippi
      • Biloxi, Mississippi, United States, 39531-2410
        • Veterans Affairs Medical Center - Biloxi
      • Jackson, Mississippi, United States, 39216-4505
        • University of Mississippi Medical Center
      • Jackson, Mississippi, United States, 39216
        • Veterans Affairs Medical Center - Jackson
      • Keesler AFB, Mississippi, United States, 39534-2576
        • Keesler Medical Center - Keesler AFB
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Veterans Affairs Medical Center - Kansas City
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, United States, 63110-0250
        • St. Louis University Health Sciences Center
      • Saint Louis, Missouri, United States, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Springfield, Missouri, United States, 65807
        • CCOP - Cancer Research for the Ozarks
    • Montana
      • Billings, Montana, United States, 59101
        • CCOP - Montana Cancer Consortium
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108-5138
        • Veterans Affairs Medical Center - Albuquerque
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Cancer Research & Treatment Center
    • New York
      • Brooklyn, New York, United States, 11209
        • Veterans Affairs Medical Center - Brooklyn
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Barrett Cancer Center, The University Hospital
      • Cincinnati, Ohio, United States, 45220-2288
        • Veterans Affairs Medical Center - Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Cancer Center
      • Columbus, Ohio, United States, 43206
        • CCOP - Columbus
      • Dayton, Ohio, United States, 45428
        • Veterans Affairs Medical Center - Dayton
      • Kettering, Ohio, United States, 45429
        • CCOP - Dayton
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Medical Research Foundation
      • Oklahoma City, Oklahoma, United States, 73104
        • Veterans Affairs Medical Center - Oklahoma City
    • Oregon
      • Portland, Oregon, United States, 97201-3098
        • Oregon Cancer Center at Oregon Health Sciences University
      • Portland, Oregon, United States, 97207
        • Veterans Affairs Medical Center - Portland
      • Portland, Oregon, United States, 97213
        • CCOP - Columbia River Program
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • CCOP - Greenville
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
      • Galveston, Texas, United States, 77555-1329
        • University of Texas Medical Branch
      • Lubbock, Texas, United States, 79423
        • Texas Tech University Health Science Center
      • San Antonio, Texas, United States, 78284
        • Veterans Affairs Medical Center - San Antonio (Murphy)
      • San Antonio, Texas, United States, 78284
        • University of Texas Health Science Center at San Antonio
      • Temple, Texas, United States, 76504
        • Veterans Affairs Medical Center - Temple
      • Temple, Texas, United States, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Huntsman Cancer Institute
      • Salt Lake City, Utah, United States, 84148
        • Veterans Affairs Medical Center - Salt Lake City
    • Washington
      • Seattle, Washington, United States, 98101
        • CCOP - Virginia Mason Research Center
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
      • Seattle, Washington, United States, 98108
        • Veterans Affairs Medical Center - Seattle
      • Tacoma, Washington, United States, 98405-0986
        • CCOP - Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically confirmed acute lymphocytic leukemia FAB class L1-L2 Mixed immunophenotypic markers with no cytochemical myeloid markers allowed No non-Hodgkin's lymphoma No chronic myelogenous leukemia in blast crisis Concurrent registration on the cytogenetics protocol SWOG-9007 required

PATIENT CHARACTERISTICS: Age: 15 to 65 Performance status: SWOG 0-3 Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times normal (unless elevation due to leukemia) AST no greater than 3 times normal (unless elevation due to leukemia) No chronic liver disease Renal: Creatinine no greater than 2 times normal Cardiovascular: Left ventricular ejection fraction at least 50% by MUGA or echocardiogram No symptomatic congestive heart failure No symptomatic coronary artery disease No cardiomyopathy No uncontrolled arrhythmia Other: Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: No prior remission induction chemotherapy for acute lymphocytic leukemia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Stephen J. Forman, MD, City of Hope Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1995

Primary Completion (Actual)

December 1, 2001

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

July 28, 2004

First Posted (Estimate)

July 29, 2004

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWOG-9400 (Other Identifier: SWOG)
  • U10CA032102 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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