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NCT02065154 · ClinicalTrials.gov registry record · Phase 2
Post Transplant Cyclophosphamide (Cytoxan) for GvHD Prophylaxis
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT02065154 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 39 participants.
The verdict
NCT02065154, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
The main purpose of this study is to assess the effects of cyclophosphamide (cytoxan) in the post transplant setting to prevent onset of acute graft-versus-host disease (GVHD). The primary objective is to determine the incidence of grade II-IV acute GVHD following Allogeneic (allo) Hematopoeitic Cell Transplant (HCT) using post-transplant cyclophosphamide (cytoxan) for patients with human leukocyte antigen (HLA) matched unrelated (MUD) and mismatched unrelated (MMUD) donors. Other objectives for this study will be the determination of disease-free survival (DFS) and overall survival (OS) following allo HCT and assess the safety of post-transplant cyclophosphamide (cytoxan) for MUD and MMUD transplantation. Disease recurrence and time to recurrence in patients receiving post-transplant cyclophosphamide compared to historical control without post-transplant cyclophosphamide (cytoxan) will also be evaluated. Other objectives will be to determine the time of onset, severity, responsiveness to treatment, organs involved of acute and chronic GVHD as well as observation of Immune Reconstitution over time.
Interventions
- DRUG Cyclophosphamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2013-08-27 |
| Est. Completion | 2022-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02065154
The ClinicalTrials.gov registry entry for NCT02065154 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cyclophosphamide is the first listed.
NCT02065154 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02065154 about?
NCT02065154 is a clinical study titled "Post Transplant Cyclophosphamide (Cytoxan) for GvHD Prophylaxis". The main purpose of this study is to assess the effects of cyclophosphamide (cytoxan) in the post transplant setting to prevent onset of acute graft-versus-host disease (GVHD). The primary objective is to determine the incidence of grade II-IV acute GVHD following Allogeneic (allo) Hematopoeitic Cel...
What is the current status of trial NCT02065154?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2013-08-27. Estimated completion is 2022-04.
What interventions are being tested in trial NCT02065154?
The interventions under investigation include: Cyclophosphamide (DRUG).
Who is sponsoring clinical trial NCT02065154?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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