S9920 Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia

NCT00005866 | Completed Phase 3

• 2 other identifiers: S9920U10CA032102
• Study Type: interventional
• Target: 240
• Locations: 2 countries
• Sites: 66

Brief Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. It is not yet known if total-body irradiation plus peripheral stem cell transplantation is more effective with busulfan or with cyclophosphamide for myelodysplastic syndrome or acute myeloid leukemia. PURPOSE: Randomized phase III trial to compare the effectiveness of busulfan with that of cyclophosphamide in patients undergoing total-body irradiation plus peripheral stem cell transplantation for advanced myelodysplastic syndrome or related acute myeloid leukemia.

Conditions

Leukemia; Myelodysplastic Syndromes

Keywords

untreated adult acute myeloid leukemia; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; chronic myelomonocytic leukemia; secondary acute myeloid leukemia; de novo myelodysplastic syndromes; secondary myelodysplastic syndromes; childhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  every 6 months after stem cell infusion until death or 5 years

Study Arms (1)

treatment

EXPERIMENTAL

Drug: busulfan; Drug: cyclophosphamide; Drug: cyclosporine; Drug: methotrexate; Procedure: allogeneic bone marrow transplantation; Radiation: radiation therapy

Interventions

busulfan DRUG

arm 1: 0.44 mg/kg every 6 hours, IV over 2 hours, day -7 to -4

treatment

cyclophosphamide DRUG

arm 2: 60 mg/kg every 24 hrs for 2 doses, IV over 2 hrs, days -5 and -4

treatment

cyclosporine DRUG

both arms per published schedule

treatment

methotrexate DRUG

GVHD: 15 mg/m2 day 1, 10 mg/m2 day 3, 6 and 11 by IV

treatment

allogeneic bone marrow transplantation PROCEDURE

day 0

treatment

radiation therapy RADIATION

both arms: 1200 cGy total dose (6 x 200 fractions)

treatment

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: Cytologically confirmed myelodysplastic syndrome (MDS) Increased blasts (i.e., greater than 1 to 30% peripheral blood blasts and/or 5 to 30% bone marrow blasts) AND International Prognostic Score intermediate 1, intermediate 2, or high risk Refractory anemia with excess blasts OR Refractory anemia with excess blasts in transformation (no presence of auer rods as sole criteria) OR Chronic myelomonocytic leukemia Greater than 1% blasts in the peripheral blood and/or at least 5% blasts in the bone marrow OR MDS related acute myeloid leukemia Arising after documented MDS of at least 60 days Absolute peripheral blast count no greater than 5,000/mm3 Must have genotypically HLA identical sibling donor Must also be enrolled on SWOG-S9910 and SWOG-9007 PATIENT CHARACTERISTICS: Age: 16 to 55 Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Other: No prior malignancy within past 5 years except: Adequately treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix Adequately treated stage I or II cancer in complete remission HIV negative Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No autologous peripheral stem cell transplantation prior to diagnosis of myelodysplastic syndrome (MDS) or MDS related acute myeloid leukemia Chemotherapy: No prior chemotherapy for MDS or MDS related acute myeloid leukemia except oral chemotherapy to control leukocytosis or thrombocytosis (e.g., hydroxyurea or etoposide) Endocrine therapy: Not specified Radiotherapy: No radiotherapy prior to diagnosis of MDS or MDS related acute myeloid leukemia Surgery: Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (66)

Good Samaritan Medical Center

Phoenix, Arizona, 85062-2989, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, 91010-3000, United States

Location

Scripps Clinic

La Jolla, California, 92037, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

St. Joseph Hospital - Orange

Orange, California, 92613-5600, United States

Location

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Sutter Cancer Center

Sacramento, California, 95816, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

Northern California Cancer Specialists Medical Clinic

Walnut Creek, California, 94598, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80010, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

St. Francis Medical Center

Honolulu, Hawaii, 96817, United States

Location

Mountain States Tumor Institute

Boise, Idaho, 83712, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Cancer Center of Kansas - Wichita

Wichita, Kansas, 67214, United States

Location

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, 40536-0084, United States

Location

Lucille Parker Markey Cancer Center, University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

Louisiana State University School of Medicine

New Orleans, Louisiana, 70112-2822, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Memorial Medical Center

New Orleans, Louisiana, 70115, United States

Location

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71130-3932, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Cancer Research Center

Boston, Massachusetts, 02118, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0752, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

St. John's Health System

Springfield, Missouri, 65804, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

St. Louis University Health Sciences Center

St Louis, Missouri, 63110-0250, United States

Location

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Jewish Hospital of Cincinnati, Inc.

Cincinnati, Ohio, 45236, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

CCOP - Dayton

Kettering, Ohio, 45429, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73190, United States

Location

Oregon Cancer Center

Portland, Oregon, 97201-3098, United States

Location

Legacy Cancer Services

Portland, Oregon, 97210, United States

Location

CCOP - Columbia River Program

Portland, Oregon, 97213, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Wilford Hall - 59th Medical Wing

Lackland Air Force Base, Texas, 78236-5300, United States

Location

Texas Tech University Health Science Center

Lubbock, Texas, 79423, United States

Location

Health Science Center

Lubbock, Texas, 79430, United States

Location

Methodist Health Care System

San Antonio, Texas, 78229, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Scott and White Clinic

Temple, Texas, 76508, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

CCOP - Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

Franciscan Health System

Tacoma, Washington, 98401-2197, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Anemia, Refractory, with Excess of Blasts; Leukemia, Myelomonocytic, Chronic

Interventions

Busulfan; Cyclophosphamide; Cyclosporine; Methotrexate; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Anemia, Refractory; Anemia; Leukemia, Myeloid; Myelodysplastic-Myeloproliferative Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Jeanne E. Anderson, MD

  Katmai Oncology Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: March 16, 2004
• Study Start: February 1, 2000
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2006
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

CA (1); US (65)