Trial · NCT01471444
Fludarabine-IV Busulfan ± Clofarabine and Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
NCT01471444, Phase 3, Completed, M.D. Anderson Cancer Center; results first posted 2021-12-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fludarabine-IV Busulfan ± Clofarabine and Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS). Trials, record NCT01471444. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01471444
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fludarabine-IV Busulfan ± Clofarabine and Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
- NCT number
- NCT01471444
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 256 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Disorder Related to Bone Marrow Transplantation, Leukemia, Transplantation Infection
- Interventions
- Fludarabine, Clofarabine, Busulfan, Thymoglobulin, Stem Cell Infusion, Tacrolimus, Methotrexate
- First posted
- 2011-11-15
- Last updated
- 2021-12-16
- Results first posted
- 2021-12-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | From day of transplant to disease of progression or death of any cause, whichever came first, assessed up to 5 years | Number of events with progression free survival. (Progression is defined as more than 5% blast in the peripheral blood or bone marrow biopsy.) or expired from treatment related mortality post transplant. |
| Secondary | Overall Survival (OS) Post Transplant at 1, 3 and 5 Years | Post transplant after 1, 3 and 5 years | Number of participants in the study who are alive and disease free at 1, 3 and 5 years post transplant. |
| Secondary | Number of Participants in the Study Who Are With no Grade 3 or 4 Acute Graft-versus-host Disease at Any Time During the First 100 Days Post Transplant. | 100 days post transplant | Number of participants in the study who are with no Grade 3 or 4 acute graft-versus-host disease at any time during the first 100 days post transplant. |
| Secondary | Number of Participants With Non Relapse Mortality at 100 Day Post Transplant | 100 day Post Transplant | Number of participants expired from complications other than relapsed disease at 100 day Post Transplant. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) | From day of transplant to disease of progression or death of any cause, whichever came first, assessed up to 5 years | Number of events | NUMBER | |
| SECONDARY | Overall Survival (OS) Post Transplant at 1, 3 and 5 Years | Post transplant after 1, 3 and 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants in the Study Who Are With no Grade 3 or 4 Acute Graft-versus-host Disease at Any Time During the First 100 Days Post Transplant. | 100 days post transplant | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Non Relapse Mortality at 100 Day Post Transplant | 100 day Post Transplant | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | Arm A (Flu+Bu) | 69 | Number of events | ||
| Progression-Free Survival (PFS) | Arm B (Flu+Clo+Bu) | 61 | Number of events | ||
| Overall Survival (OS) Post Transplant at 1, 3 and 5 Years | Arm A (Flu+Bu) | 1 Year Post Transplant | 83 | Participants | |
| Overall Survival (OS) Post Transplant at 1, 3 and 5 Years | Arm B (Flu+Clo+Bu) | 1 Year Post Transplant | 82 | Participants | |
| Overall Survival (OS) Post Transplant at 1, 3 and 5 Years | Arm A (Flu+Bu) | 3 Year Post Transplant | 69 | Participants | |
| Overall Survival (OS) Post Transplant at 1, 3 and 5 Years | Arm B (Flu+Clo+Bu) | 3 Year Post Transplant | 69 | Participants | |
| Overall Survival (OS) Post Transplant at 1, 3 and 5 Years | Arm A (Flu+Bu) | 5 Year Post Transplant | 64 | Participants | |
| Overall Survival (OS) Post Transplant at 1, 3 and 5 Years | Arm B (Flu+Clo+Bu) | 5 Year Post Transplant | 63 | Participants | |
| Number of Participants in the Study Who Are With no Grade 3 or 4 Acute Graft-versus-host Disease at Any Time During the First 100 Days Post Transplant. | Arm A (Flu+Bu) | 125 | Participants | ||
| Number of Participants in the Study Who Are With no Grade 3 or 4 Acute Graft-versus-host Disease at Any Time During the First 100 Days Post Transplant. | Arm B (Flu+Clo+Bu) | 115 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Flu+Bu) | 133 | |
| Overall Study | STARTED | Arm B (Flu+Clo+Bu) | 123 | |
| Overall Study | COMPLETED | Arm A (Flu+Bu) | 130 | |
| Overall Study | COMPLETED | Arm B (Flu+Clo+Bu) | 120 | |
| Overall Study | NOT COMPLETED | Arm A (Flu+Bu) | 3 | |
| Overall Study | NOT COMPLETED | Arm B (Flu+Clo+Bu) | 3 |
Source ClinicalTrials.gov
Adverse events114
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 | Infections | Infections and infestations | Arm A (Flu+Bu) | 103 | 130 | |
| other | Infections | Infections and infestations | Arm B (Flu+Clo+Bu) | 89 | 120 | |
| other | ATG induced fevers | Investigations | Arm A (Flu+Bu) | 65 | 130 | |
| other | ATG induced fevers | Investigations | Arm B (Flu+Clo+Bu) | 41 | 120 | |
| other | Allergic reaction to ATG | Immune system disorders | Arm A (Flu+Bu) | 2 | 130 | |
| other | Allergic reaction to ATG | Immune system disorders | Arm B (Flu+Clo+Bu) | 4 | 120 | |
| other | Fluid overload | General disorders | Arm A (Flu+Bu) | 58 | 130 | |
| other | Fluid overload | General disorders | Arm B (Flu+Clo+Bu) | 54 | 120 | |
| other | ABO incompatibility | Blood and lymphatic system disorders | Arm A (Flu+Bu) | 4 | 130 | |
| other | ABO incompatibility | Blood and lymphatic system disorders | Arm B (Flu+Clo+Bu) | 0 | 120 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Flu+Bu) | 67 | 130 |
| Total, all-cause mortality | Arm B (Flu+Clo+Bu) | 59 | 120 |
| Total, other adverse events | Arm A (Flu+Bu) | 123 | 130 |
| Total, other adverse events | Arm B (Flu+Clo+Bu) | 120 | 120 |
| Total, serious adverse events | Arm A (Flu+Bu) | 25 | 130 |
| Total, serious adverse events | Arm B (Flu+Clo+Bu) | 39 | 120 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (Flu+Bu) vs Arm B (Flu+Clo+Bu): Number of Participants in the Study Who Are With no Grade 3 or 4 Acute Graft-versus-host Disease at Any Time During the First 100 Days Post Transplant. | Trial comparisons |
| Arm A (Flu+Bu) vs Arm B (Flu+Clo+Bu): Number of Participants With Non Relapse Mortality at 100 Day Post Transplant | Trial comparisons |
| Arm A (Flu+Bu) vs Arm B (Flu+Clo+Bu): deaths from any cause | Trial comparisons |
| Arm A (Flu+Bu) vs Arm B (Flu+Clo+Bu): 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/NCT01471444
GET https://conductscience.org/api/trials/v1/NCT01471444/events?page=2