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NCT01885689 · ClinicalTrials.gov registry record · Phase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
A Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT01885689: Active Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, sponsored by City of Hope Medical Center.
NCT01885689 is a Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 72 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01885689, a Phase 2 study of Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well clofarabine and melphalan before a donor stem cell transplant works in treating patients with a decrease in or disappearance of signs and symptoms of myelodysplasia or acute leukemia (disease is in remission), or chronic myelomonocytic leukemia. Giving chemotherapy, such as clofarabine and melphalan, before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into a patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving clofarabine and melphalan before transplant may help prevent the cancer from coming back after transplant, and they may cause fewer side effects than standard treatment.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG tacrolimus
- DRUG clofarabine
- DRUG melphalan
- PROCEDURE allogeneic hematopoietic stem cell transplantation
- DRUG sirolimus
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2014-02-10 |
| Est. Completion | 2026-09-21 |
| Phase | Phase 2 |
What the registry record for NCT01885689 still lists
NCT01885689 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (65% lower).
The record links to 7 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 5 interventions - of which tacrolimus is the first listed.
NCT01885689 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01885689 about?
NCT01885689 is a clinical study titled "Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia". This phase II trial studies how well clofarabine and melphalan before a donor stem cell transplant works in treating patients with a decrease in or disappearance of signs and symptoms of myelodysplasia or acute leukemia (disease is in remission), or chronic myelomonocytic leukemia. Giving chemothera...
What is the current status of trial NCT01885689?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2014-02-10. Estimated completion is 2026-09-21.
What conditions does trial NCT01885689 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Adult Acute Myeloid Leukemia in Remission, Adult Acute Lymphoblastic Leukemia in Remission.
What interventions are being tested in trial NCT01885689?
The interventions under investigation include: tacrolimus (DRUG), clofarabine (DRUG), melphalan (DRUG), allogeneic hematopoietic stem cell transplantation (PROCEDURE), sirolimus (DRUG).
Who is sponsoring clinical trial NCT01885689?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01885689 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01885689's enrollment target sits among peer trials
72 48th of 134 higher than 85 of 134 other Myelodysplastic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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