LeukemiaPhase 3NCT00005866
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
A Phase 3 study testing busulfan, cyclophosphamide and cyclosporine in people with Leukemia and Myelodysplastic Syndromes, run by SWOG Cancer Research Network at 66 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Leukemia, Myelodysplastic Syndromes
- What is being tested?
- busulfan, cyclophosphamide and cyclosporine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 66 sitesin 2 countries
- Study dates
- Feb 2000to Mar 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Trial locations and contacts
66 sites in 2 countries.
66 sites in 2 countries
United States65 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
Mountain States Tumor Institute
Boise, Idaho, 83712
Boston Medical Center
Boston, Massachusetts, 02118
Cancer Research Center
Boston, Massachusetts, 02118
Jewish Hospital of Cincinnati, Inc.
Cincinnati, Ohio, 45236
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Miami Valley Hospital
Dayton, Ohio, 45409
University of Colorado Cancer Center
Denver, Colorado, 80010
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Henry Ford Hospital
Detroit, Michigan, 48202
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
Queen's Medical Center
Honolulu, Hawaii, 96813
St. Francis Medical Center
Honolulu, Hawaii, 96817
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
CCOP - Dayton
Kettering, Ohio, 45429
Scripps Clinic
La Jolla, California, 92037
Wilford Hall - 59th Medical Wing
Lackland Air Force Base, Texas, 78236-5300
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, 40536-0093
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Texas Tech University Health Science Center
Lubbock, Texas, 79423
Health Science Center
Lubbock, Texas, 79430
Loyola University Medical Center
Maywood, Illinois, 60153
Louisiana State University School of Medicine
New Orleans, Louisiana, 70112-2822
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
Tulane University School of Medicine
New Orleans, Louisiana, 70112
Memorial Medical Center
New Orleans, Louisiana, 70115
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73190
St. Joseph Hospital - Orange
Orange, California, 92613-5600
Chao Family Comprehensive Cancer Center
Orange, California, 92868
Good Samaritan Medical Center
Phoenix, Arizona, 85062-2989
Oregon Cancer Center
Portland, Oregon, 97201-3098
Legacy Cancer Services
Portland, Oregon, 97210
CCOP - Columbia River Program
Portland, Oregon, 97213
Providence St. Vincent Medical Center
Portland, Oregon, 97225
Sutter Cancer Center
Sacramento, California, 95816
University of California Davis Cancer Center
Sacramento, California, 95817
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
LDS Hospital
Salt Lake City, Utah, 84143
Methodist Health Care System
San Antonio, Texas, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
Swedish Cancer Institute
Seattle, Washington, 98104
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
University of Washington Medical Center
Seattle, Washington, 98195-6043
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
St. John's Health System
Springfield, Missouri, 65804
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
St. Louis University Health Sciences Center
St Louis, Missouri, 63110-0250
Stanford University Medical Center
Stanford, California, 94305-5408
Franciscan Health System
Tacoma, Washington, 98401-2197
CCOP - Northwest
Tacoma, Washington, 98405-0986
CCOP - Scott and White Hospital
Temple, Texas, 76508
Scott and White Clinic
Temple, Texas, 76508
Arizona Cancer Center
Tucson, Arizona, 85724
Northern California Cancer Specialists Medical Clinic
Walnut Creek, California, 94598
CCOP - Wichita
Wichita, Kansas, 67214-3882
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214
About this study
Official title: A Phase III Randomized Study Comparing Busulfan-Total Body Irradiation Versus Cyclophosphamide-Total Body Irradiation Preparative Regimen in Patients With Advanced Myelodysplastic Syndrome (MDS) or MDS-Related Acute Myeloid Leukemia (AML) Undergoing HLA-Identical Sibling Peripheral Blood Stem Cell Transplantation, (A BMT Study)
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.
Read the detailed description
OBJECTIVES: I. Compare event free survival after total body irradiation (TBI) plus busulfan versus TBI plus cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation in patients with advanced myelodysplastic syndrome (MDS) or MDS related acute myeloid leukemia. II. Determine the distribution of pharmacokinetic parameters for busulfan in those patients randomized to the busulfan treatment arm. III. Investigate the prognostic significance for event free survival of prior history of red cell transfusions, cytogenetic pattern, and of functional drug resistance at diagnosis in these patients. IV. Estimate the frequencies of cytogenetic and genetic changes during disease progression in these patients.
OUTLINE: This a randomized, multicenter study. Patients are stratified according to age (40 and under vs 41-55) and diagnosis and International Prognostic Scoring System (IPSS) risk group (myelodysplastic syndrome (MDS)/IPSS - intermediate 1 vs MDS/IPSS - intermediate 2 vs MDS/IPSS high risk vs MDS related acute myeloid leukemia). Patients are randomized to one of two treatment arms. Arm I: Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 for a total of 16 doses. Arm II: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients receive total body irradiation (TBI) twice a day on days -3 to -1; peripheral blood stem cell transplantation from genotypically HLA identical sibling on day 0; cyclosporine IV every 12 hours on days -1 to 60, and then tapering in the absence of graft versus host disease; and methotrexate IV on days 1, 3, 6, and 11. Patients are followed every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 240 patients (120 per treatment arm) will be accrued for this study over 5 years.
- Conditions
- Leukemia, Myelodysplastic Syndromes
- Being tested
- busulfan, cyclophosphamide, cyclosporine, methotrexate, allogeneic bone marrow transplantation
- 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
- Medical subject headings
- Leukemia, Myelodysplastic Syndromes, Anemia, Refractory, with Excess of Blasts, Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
busulfanDrug
arm 1: 0.44 mg/kg every 6 hours, IV over 2 hours, day -7 to -4
cyclophosphamideDrug
arm 2: 60 mg/kg every 24 hrs for 2 doses, IV over 2 hrs, days -5 and -4
cyclosporineDrug
both arms per published schedule
methotrexateDrug
GVHD: 15 mg/m2 day 1, 10 mg/m2 day 3, 6 and 11 by IV
allogeneic bone marrow transplantationProcedure or surgery
day 0
radiation therapyRadiation
both arms: 1200 cGy total dose (6 x 200 fractions)
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Not described Receives: Drug: busulfan; Drug: cyclophosphamide; Drug: cyclosporine; Drug: methotrexate; Procedure: allogeneic bone marrow transplantation; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Measured: every 6 months after stem cell infusion until death or 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2004 (estimated)
- Study startFeb 2000
- Primary completionMar 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeanne E. Anderson, MD, Study chair, Katmai Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005866
- Sponsor's protocol ID
- S9920
- Other IDs
- S9920, U10CA032102
- Status last verified
- Mar 2015
- First submitted
- 2 Jun 2000
- Last updated
- 6 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Study Comparing Busulfan-Total Body Irradiation Versus Cyclophosphamide-Total Body Irradiation Preparative Regimen in Patients With Advanced Myelodysplastic Syndrome (MDS) or MDS-Related Acute Myeloid Leukemia (AML) Undergoing HLA-Identical Sibling Peripheral Blood Stem Cell Transplantation, (A BMT Study)
- ClinicalTrials.gov ID
- NCT00005866
- Acronym / sponsor ID
- S9920
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2000
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 16 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES: I. Compare event free survival after total body irradiation (TBI) plus busulfan versus TBI plus cyclophosphamide followed by allogeneic peripheral blood stem cell transplantation in patients with advanced myelodysplastic syndrome (MDS) or MDS related acute myeloid leukemia. II. Determine the distribution of pharmacokinetic parameters for busulfan in those patients randomized to the busulfan treatment arm. III. Investigate the prognostic significance for event free survival of prior history of red cell transfusions, cytogenetic pattern, and of functional drug resistance at diagnosis in these patients. IV. Estimate the frequencies of cytogenetic and genetic changes during disease progression in these patients.
OUTLINE: This a randomized, multicenter study. Patients are stratified according to age (40 and under vs 41-55) and diagnosis and International Prognostic Scoring System (IPSS) risk group (myelodysplastic syndrome (MDS)/IPSS - intermediate 1 vs MDS/IPSS - intermediate 2 vs MDS/IPSS high risk vs MDS related acute myeloid leukemia). Patients are randomized to one of two treatment arms. Arm I: Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 for a total of 16 doses. Arm II: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients receive total body irradiation (TBI) twice a day on days -3 to -1; peripheral blood stem cell transplantation from genotypically HLA identical sibling on day 0; cyclosporine IV every 12 hours on days -1 to 60, and then tapering in the absence of graft versus host disease; and methotrexate IV on days 1, 3, 6, and 11. Patients are followed every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 240 patients (120 per treatment arm) will be accrued for this study over 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: busulfan, Drug: cyclophosphamide, Drug: cyclosporine, Drug: methotrexate, Procedure: allogeneic bone marrow transplantation, Radiation: radiation therapy |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| busulfanarm 1: 0.44 mg/kg every 6 hours, IV over 2 hours, day -7 to -4 | Drug | treatment |
| cyclophosphamidearm 2: 60 mg/kg every 24 hrs for 2 doses, IV over 2 hrs, days -5 and -4 | Drug | treatment |
| cyclosporineboth arms per published schedule | Drug | treatment |
| methotrexateGVHD: 15 mg/m2 day 1, 10 mg/m2 day 3, 6 and 11 by IV | Drug | treatment |
| allogeneic bone marrow transplantationday 0 | Procedure or surgery | treatment |
| radiation therapyboth arms: 1200 cGy total dose (6 x 200 fractions) | Radiation | treatment |
Primary outcome
Event-free survival
Time frame: every 6 months after stem cell infusion until death or 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne E. Anderson, MD study chair
Katmai Oncology Group
66 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing busulfan, cyclophosphamide and cyclosporine in people with Leukemia and Myelodysplastic Syndromes, run by SWOG Cancer Research Network at 66 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival (time frame: every 6 months after stem cell infusion until death or 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.