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NCT04965597 · ClinicalTrials.gov registry record · Phase 2
Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904)
A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT04965597: Completed Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
NCT04965597 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04965597, a Phase 2 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
This phase II trial tests whether treosulfan, fludarabine, and rabbit antithymocyte globulin (rATG) work when given before a blood or bone marrow transplant (conditioning regimen) to cause fewer complications for patients with bone marrow failure diseases. Chemotherapy drugs, such as treosulfan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Fludarabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. rATG is used to decrease the body's immune response and may improve bone marrow function and increase blood cell counts. Adding treosulfan to a conditioning regimen with fludarabine and rATG may result in patients having less severe complications after a blood or bone marrow transplant.
Primary Outcome
The primary endpoint is the incidence of 1-year GVHD free, EFS (GEFS). An event is defined as death due to any cause, primary or secondary graft failure/rejection, or 2nd HCT whichever occurs first. Grade III-IV acute GVHD and chronic GVHD (using National Institutes of Health \[NIH\] consensus criteria) requiring systemic immune suppression will be considered in this estimate.
Interventions
- BIOLOGICAL Lapine T-Lymphocyte Immune Globulin
- DRUG Fludarabine Phosphate
- DRUG Tacrolimus
- DRUG Methotrexate
- DRUG Treosulfan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-04-19 |
| Est. Completion | 2026-02-18 |
| Phase | Phase 2 |
What the finished NCT04965597 record still lists
NCT04965597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 5 interventions - of which Lapine T-Lymphocyte Immune Globulin is the first listed.
NCT04965597 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04965597 about?
NCT04965597 is a clinical study titled "Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904)". This phase II trial tests whether treosulfan, fludarabine, and rabbit antithymocyte globulin (rATG) work when given before a blood or bone marrow transplant (conditioning regimen) to cause fewer complications for patients with bone marrow failure diseases. Chemotherapy drugs, such as treosulfan, wor...
What is the current status of trial NCT04965597?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2022-04-19. Estimated completion is 2026-02-18.
What interventions are being tested in trial NCT04965597?
The interventions under investigation include: Lapine T-Lymphocyte Immune Globulin (BIOLOGICAL), Fludarabine Phosphate (DRUG), Tacrolimus (DRUG), Methotrexate (DRUG), Treosulfan (DRUG).
Who is sponsoring clinical trial NCT04965597?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04965597's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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