Trial · NCT01339910
Reduced Intensity Regimen vs Myeloablative Regimen for Myeloid Leukemia or Myelodysplastic Syndrome (BMT CTN 0901)
NCT01339910, Phase 3, Terminated, Medical College of Wisconsin; results first posted 2018-05-30
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Reduced Intensity Regimen vs Myeloablative Regimen for Myeloid Leukemia or Myelodysplastic Syndrome (BMT CTN 0901). Trials, record NCT01339910. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01339910
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reduced Intensity Regimen vs Myeloablative Regimen for Myeloid Leukemia or Myelodysplastic Syndrome (BMT CTN 0901)
- NCT number
- NCT01339910
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 272 participants, actual
- Lead sponsor
- Medical College of Wisconsin
- Conditions
- Leukemia, Myelocytic, Acute
- Interventions
- Fludarabine and Busulfan, Fludarabine and Melphalan, Busulfan and Fludarabine, Busulfan and Cyclophosphamide, Cyclophosphamide and Total Body Irradiation
- First posted
- 2011-04-21
- Last updated
- 2023-01-04
- Results first posted
- 2018-05-30
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Overall Survival (OS) | 18 months post-randomization | Overall survival is defined as survival of death from any cause. |
| Secondary | Percentage of Participants With Relapse-Free Survival (RFS) | 18 months post-randomization | Relapse-free survival is defined as survival without relapse of the primary disease. |
| Secondary | Percentage of Participants With Disease Relapse | 18 months post-randomization | Disease Relapse is defined as relapse of the primary disease. |
| Secondary | Percentage of Participants With Treatment-related Mortality | 18 months post-randomization | Treatment-related mortality is defined as death without a previous relapse of the primary disease. |
| Secondary | Percentage of Participants With Neutrophil and Platelet Engraftment | Days 28 and 60 post-transplant | Neutrophil engraftment is defined as achieving an absolute neutrophil count greater than 500x10\^6/liter for 3 consecutive measurements on different days. The first of the 3 days will be designated the day of neutrophil engraftment. Platelet engraftment is defined as achieving platelet counts greater than 20,000/microliter for consecutive measurements over 7 days without requiring platelet transfusions. The first of the 7 days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 7 days. |
| Secondary | Number of Participants With Donor Cell Engraftment | Days 28 and 100 and 18 months post-transplant | Donor cell engraftment will be assessed by donor-recipient chimerism assays. Full donor chimerism is defined as the presence of at least 95% donor cells as a proportion of the total population in the peripheral blood or bone marrow. Graft rejection is defined as the presence of no more than 5% donor cells as a proportion of the total population. Mixed chimerism is defined as the presence of between 5% and 95% donor cells. Mixed or full donor chimerism will be considered evidence of donor engraftment. |
| Secondary | Percentage of Participants With Acute Graft Versus Host Disease (GVHD) | Day 100 post-transplant | Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995: Skin stage: 0: No rash 1. Rash \<25% of body surface area 2. Rash on 25-50% of body surface area 3. Rash on \> 50% of body surface area 4. Generalized erythroderma with bullous formation Liver stage (based on bilirubin level)\*: 0: \<2 mg/dL 1. 2-3 mg/dL 2. 3.01-6 mg/dL 3. 6.01-15.0 mg/dL 4. \>15 mg/dL GI stage\*: 0: No diarrhea or diarrhea \<500 mL/day 1. Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD 2. Diarrhea 1000-1499 mL/day 3. Diarrhea \>1500 mL/day 4. Severe abdominal pain with or without ileus \* If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1. GVHD grade: 0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4 |
| Secondary | Percentage of Participants With Chronic GVHD | 18 months post-transplant | Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe. Occurrence of chronic GVHD is defined as the occurrence of mild, moderate, or severe chronic GVHD per this classification. |
| Secondary | Number of Participants With Chronic GVHD Severity | 18 months post-transplant | Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe. |
| Secondary | Number of Participants With Primary Graft Failure | 28 days post-transplant | Primary graft failure is defined by lack of neutrophil engraftment. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Overall Survival (OS) | 18 months post-randomization | percentage | NUMBER | |
| SECONDARY | Percentage of Participants With Relapse-Free Survival (RFS) | 18 months post-randomization | percentage | NUMBER | |
| SECONDARY | Percentage of Participants With Disease Relapse | 18 months post-randomization | percentage | NUMBER | |
| SECONDARY | Percentage of Participants With Treatment-related Mortality | 18 months post-randomization | percentage | NUMBER | |
| SECONDARY | Percentage of Participants With Neutrophil and Platelet Engraftment | Days 28 and 60 post-transplant | Transplanted participants | percentage | NUMBER |
| SECONDARY | Number of Participants With Donor Cell Engraftment | Days 28 and 100 and 18 months post-transplant | Transplanted participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Acute Graft Versus Host Disease (GVHD) | Day 100 post-transplant | Transplanted participants | percentage | NUMBER |
| SECONDARY | Percentage of Participants With Chronic GVHD | 18 months post-transplant | Transplanted participants | percentage | NUMBER |
| SECONDARY | Number of Participants With Chronic GVHD Severity | 18 months post-transplant | Transplanted participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Primary Graft Failure | 28 days post-transplant | Transplanted participants | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group98
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Overall Survival (OS) | Myeloablative Conditioning Regimen (MAC) | 77.5 | 95% Confidence Interval 69.4 to 83.7 | percentage | |
| Percentage of Participants With Overall Survival (OS) | Reduced Intensity Conditioning (RIC) | 67.7 | 95% Confidence Interval 59.1 to 74.9 | percentage | |
| Percentage of Participants With Relapse-Free Survival (RFS) | Myeloablative Conditioning Regimen (MAC) | 67.8 | 95% Confidence Interval 59.1 to 75.0 | percentage | |
| Percentage of Participants With Relapse-Free Survival (RFS) | Reduced Intensity Conditioning (RIC) | 47.3 | 95% Confidence Interval 38.7 to 55.4 | percentage | |
| Percentage of Participants With Disease Relapse | Myeloablative Conditioning Regimen (MAC) | 13.5 | 95% Confidence Interval 8.3 to 19.8 | percentage | |
| Percentage of Participants With Disease Relapse | Reduced Intensity Conditioning (RIC) | 48.3 | 95% Confidence Interval 39.6 to 56.4 | percentage | |
| Percentage of Participants With Treatment-related Mortality | Myeloablative Conditioning Regimen (MAC) | 15.8 | 95% Confidence Interval 10.2 to 22.5 | percentage | |
| Percentage of Participants With Treatment-related Mortality | Reduced Intensity Conditioning (RIC) | 4.4 | 95% Confidence Interval 1.8 to 8.9 | percentage | |
| Percentage of Participants With Neutrophil and Platelet Engraftment | Myeloablative Conditioning Regimen (MAC) | Neutrophil Engraftment at Day 28 | 98.5 | percentage | |
| Percentage of Participants With Neutrophil and Platelet Engraftment | Reduced Intensity Conditioning (RIC) | Neutrophil Engraftment at Day 28 | 97.8 | percentage |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Myeloablative Conditioning Regimen (MAC) | 135 | |
| Overall Study | STARTED | Reduced Intensity Conditioning (RIC) | 137 | |
| Overall Study | COMPLETED | Myeloablative Conditioning Regimen (MAC) | 132 | |
| Overall Study | COMPLETED | Reduced Intensity Conditioning (RIC) | 133 | |
| Overall Study | NOT COMPLETED | Myeloablative Conditioning Regimen (MAC) | 3 | |
| Overall Study | NOT COMPLETED | Reduced Intensity Conditioning (RIC) | 4 |
Source ClinicalTrials.gov
Adverse events106
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Chest pain | General disorders | Myeloablative Conditioning Regimen (MAC) | 1 | 132 | 1 |
| other | Chest pain | General disorders | Reduced Intensity Conditioning (RIC) | 0 | 133 | 0 |
| other | Weight decreased | Investigations | Myeloablative Conditioning Regimen (MAC) | 2 | 132 | 2 |
| other | Weight decreased | Investigations | Reduced Intensity Conditioning (RIC) | 1 | 133 | 1 |
| other | Arthritis | Musculoskeletal and connective tissue disorders | Myeloablative Conditioning Regimen (MAC) | 1 | 132 | 1 |
| other | Arthritis | Musculoskeletal and connective tissue disorders | Reduced Intensity Conditioning (RIC) | 0 | 133 | 0 |
| other | Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Myeloablative Conditioning Regimen (MAC) | 1 | 132 | 1 |
| other | Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Reduced Intensity Conditioning (RIC) | 0 | 133 | 0 |
| other | Large granular lymphocytosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Myeloablative Conditioning Regimen (MAC) | 1 | 132 | 1 |
| other | Large granular lymphocytosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Reduced Intensity Conditioning (RIC) | 1 | 133 | 1 |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Myeloablative Conditioning Regimen (MAC) | ||
| Total, all-cause mortality | Reduced Intensity Conditioning (RIC) | ||
| Total, other adverse events | Myeloablative Conditioning Regimen (MAC) | 7 | 132 |
| Total, other adverse events | Reduced Intensity Conditioning (RIC) | 4 | 133 |
| Total, serious adverse events | Myeloablative Conditioning Regimen (MAC) | 21 | 132 |
| Total, serious adverse events | Reduced Intensity Conditioning (RIC) | 16 | 133 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U24CA076518 | A Data Resource for Blood and Marrow Transplants and Adoptive Cellular Therapy Research | SHAW, BRONWEN; MOSKOP, AMY M | MEDICAL COLLEGE OF WISCONSIN | NATIONAL CANCER INSTITUTE | 1998 to 2025 | NIH RePORTER |
| U01HL069294 | BMT Clinical Research Network Data Coordinating Center | HOROWITZ, MARY MARESCA | MEDICAL COLLEGE OF WISCONSIN | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2001 to 2010 | NIH RePORTER |
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Myeloablative Conditioning Regimen (MAC) vs Reduced Intensity Conditioning (RIC): Number of Participants With Primary Graft Failure | Trial comparisons |
| Myeloablative Conditioning Regimen (MAC) vs Reduced Intensity Conditioning (RIC): Number of Participants With Secondary Graft Failure | Trial comparisons |
| Myeloablative Conditioning Regimen (MAC) vs Reduced Intensity Conditioning (RIC): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01339910
GET https://conductscience.org/api/trials/v1/NCT01339910/results?page=2