Trial · NCT01885689
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
NCT01885689, Phase 2, Active not recruiting, City of Hope Medical Center; results first posted 2023-04-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia. Trials, record NCT01885689. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01885689
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
- NCT number
- NCT01885689
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 72 participants, actual
- Lead sponsor
- City of Hope Medical Center
- Conditions
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Adult Acute Myeloid Leukemia in Remission, Myelodysplastic Syndrome, Secondary Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, Therapy-Related Myelodysplastic Syndrome
- Interventions
- clofarabine, melphalan, allogeneic hematopoietic stem cell transplantation, tacrolimus, sirolimus, Pharmacological Study
- First posted
- 2013-06-25
- Last updated
- 2026-11-06
- Results first posted
- 2023-04-04
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival at 2 Years | From start of protocol treatment to death due to any cause, disease relapse/progression, or last follow-up, whichever comes first, assessed up to 2 years. | Progression-free survival (PFS) is defined as time from start of protocol treatment to disease relapse/progression, death or last contact, whichever occurs first. Progression-free survival was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. |
| Secondary | Overall Survival at 2 Years | From start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 2 years. | Overall survival (OS) is defined as time from start of protocol treatment to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival at 2 Years | From start of protocol treatment to death due to any cause, disease relapse/progression, or last follow-up, whichever comes first, assessed up to 2 years. | percent probability | NUMBER | |
| SECONDARY | Overall Survival at 2 Years | From start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 2 years. | percent probability | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival at 2 Years | Treatment (Clofarabine, Melphalan, Transplant) | 54 | 95% Confidence Interval 39 to 66 | percent probability | |
| Overall Survival at 2 Years | Treatment (Clofarabine, Melphalan, Transplant) | 67 | 95% Confidence Interval 53 to 78 | percent probability |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Clofarabine, Melphalan, Transplant) | 52 | |
| Overall Study | COMPLETED | Treatment (Clofarabine, Melphalan, Transplant) | 52 | |
| Overall Study | NOT COMPLETED | Treatment (Clofarabine, Melphalan, Transplant) | 0 |
Source ClinicalTrials.gov
Adverse events252
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 | Anemia | Blood and lymphatic system disorders | Treatment (Clofarabine, Melphalan, Transplant) | 51 | 52 | 118 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Treatment (Clofarabine, Melphalan, Transplant) | 5 | 52 | 8 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Treatment (Clofarabine, Melphalan, Transplant) | 31 | 52 | 34 |
| other | Spleen disorder | Blood and lymphatic system disorders | Treatment (Clofarabine, Melphalan, Transplant) | 1 | 52 | 1 |
| other | Acute coronary syndrome | Cardiac disorders | Treatment (Clofarabine, Melphalan, Transplant) | 1 | 52 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Treatment (Clofarabine, Melphalan, Transplant) | 4 | 52 | 5 |
| other | Atrial flutter | Cardiac disorders | Treatment (Clofarabine, Melphalan, Transplant) | 2 | 52 | 2 |
| other | Cardiac disorders - Other, specify | Cardiac disorders | Treatment (Clofarabine, Melphalan, Transplant) | 12 | 52 | 17 |
| other | Chest pain - cardiac | Cardiac disorders | Treatment (Clofarabine, Melphalan, Transplant) | 6 | 52 | 6 |
| other | Heart failure | Cardiac disorders | Treatment (Clofarabine, Melphalan, Transplant) | 3 | 52 | 3 |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Clofarabine, Melphalan, Transplant) | 23 | 52 |
| Total, other adverse events | Treatment (Clofarabine, Melphalan, Transplant) | 52 | 52 |
| Total, serious adverse events | Treatment (Clofarabine, Melphalan, Transplant) | 16 | 52 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01885689
GET https://conductscience.org/api/trials/v1/NCT01885689/events?page=2