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NCT02928991 · ClinicalTrials.gov registry record · Early Phase 1
Fludarabine Based RIC for Bone Marrow Failure Syndromes
A Early Phase 1 study of Bone Marrow Failure Syndromes, sponsored by Children's Hospital of Philadelphia.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT02928991: Recruiting Early Phase 1 study of Bone Marrow Failure Syndromes, sponsored by Children's Hospital of Philadelphia.
NCT02928991 is a Early Phase 1 study of Bone Marrow Failure Syndromes that is actively recruiting participants, run by Children's Hospital of Philadelphia. The registered enrollment target is 25 participants, below the 615-participant average among 3 other Bone Marrow Failure Syndromes trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02928991, a Early Phase 1 study of Bone Marrow Failure Syndromes, is actively recruiting participants, sponsored by Children's Hospital of Philadelphia.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot study to determine whether fludarabine-based reduced intensity conditioning (RIC) regimens facilitate successful donor engraftment of patients with acquired aplastic anemia (AA) and Inherited bone marrow failure (iBMF) syndromes undergoing Matched related donor bone marrow transplant (MRD-BMT).
Primary Outcome
Combined rate of primary and secondary graft failure. Primary graft failure is defined as no evidence of neutrophil engraftment by day +28 after stem cell infusion. Secondary graft failure is defined as an ANC\<100 for \>7-10 days after initial engraftment occurs and is confirmed by hypocellular bone marrow biopsy and donor engraftment \<20%.
Conditions Studied
Interventions
- OTHER MRD-BMT with Fludarabine-based RIC for Acquired AA
- OTHER MRD-BMT with Fludarabine-based RIC for iBMF with trilineage aplasia
- OTHER MRD-BMT with Fludarabine-based RIC for iBMF without trilineage aplasia
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2015-04 |
| Est. Completion | 2027-12 |
| Phase | Early Phase 1 |
What NCT02928991 shows while recruiting
NCT02928991 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 615-participant average among 3 other Bone Marrow Failure Syndromes trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Bone Marrow Failure Syndromes appearing as the primary indexed condition, and to 3 interventions - of which MRD-BMT with Fludarabine-based RIC for Acquired AA is the first listed.
NCT02928991 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02928991 about?
NCT02928991 is a clinical study titled "Fludarabine Based RIC for Bone Marrow Failure Syndromes". This is a pilot study to determine whether fludarabine-based reduced intensity conditioning (RIC) regimens facilitate successful donor engraftment of patients with acquired aplastic anemia (AA) and Inherited bone marrow failure (iBMF) syndromes undergoing Matched related donor bone marrow transplant...
What is the current status of trial NCT02928991?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 25 participants. The study started on 2015-04. Estimated completion is 2027-12.
What conditions does trial NCT02928991 study?
This clinical trial studies the following conditions: Bone Marrow Failure Syndromes.
What interventions are being tested in trial NCT02928991?
The interventions under investigation include: MRD-BMT with Fludarabine-based RIC for Acquired AA (OTHER), MRD-BMT with Fludarabine-based RIC for iBMF with trilineage aplasia (OTHER), MRD-BMT with Fludarabine-based RIC for iBMF without trilineage aplasia (OTHER).
Who is sponsoring clinical trial NCT02928991?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02928991 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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