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NCT01835587 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS).
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT01835587 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 31 participants.
The verdict
NCT01835587, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
The purpose of the study is to determine the maximal tolerated dose and schedule of CC-486, known as oral azacitidine, in patients with AML or MDS after allogeneic hematopoetic stem cell transplant (HSCT). HSCT is more frequently used in AML or MDS as a potential curative therapy. However, disease recurrence/relapse and graft-versus-host disease (GVHD) remain the principal causes of fatal complications after transplantation. Oral azacitidine has significant activity in MDS and AML. Oral azacitidine has also demonstrated immunomodulatory activity in AML patients after allogeneic HSCT. An oral formulation of oral azacitidine provides a convenient route of administration and an opportunity to deliver the drug over a prolonged schedule.
Interventions
- DRUG CC-486
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2013-10-25 |
| Est. Completion | 2017-05-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01835587
The ClinicalTrials.gov registry entry for NCT01835587 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CC-486 is the first listed.
NCT01835587 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01835587 about?
NCT01835587 is a clinical study titled "Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS).". The purpose of the study is to determine the maximal tolerated dose and schedule of CC-486, known as oral azacitidine, in patients with AML or MDS after allogeneic hematopoetic stem cell transplant (HSCT). HSCT is more frequently used in AML or MDS as a potential curative therapy. However, disease r...
What is the current status of trial NCT01835587?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2013-10-25. Estimated completion is 2017-05-26.
What interventions are being tested in trial NCT01835587?
The interventions under investigation include: CC-486 (DRUG).
Who is sponsoring clinical trial NCT01835587?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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