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NCT03600909 · ClinicalTrials.gov registry record · Phase 2
A Study of the Effect of Blood Stem Cell Transplant After Chemotherapy Alone in Patients With Fanconi Anemia
A Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT03600909: Clinical Trial Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT03600909 is a Phase 2 study that was terminated before completion, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03600909, a Phase 2 study, was terminated before completion, sponsored by Memorial Sloan Kettering Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
The goal of this study is to see if the study therapy can decrease the chemotherapy-related side effects while maximizing the effectiveness of disease control. The physicians will also be studying the effect of removing T-cells from the donor"s stem cells before transplant. T-cells are a type of white blood cell that may help cause a serious side effect of transplant called Graft versus Host Disease (GVHD). The way it removes the T-cells from the donor stem cells is actually by selecting only the stem cells (called CD34 cells) by using a device called CliniMACS. This process is called CD34 selection. The CliniMACS® device is currently under the supervision of the FDA .
Primary Outcome
Primary non-engraftment is diagnosed when the patient fails to achieve an ANC ≥500/µl at any time in the first 28 days post-transplant. If (1) after achievement of an ANC ≥500/mm\^3, the ANC declines to \<500/mm\^3 for more than 3 consecutive days in the absence of relapse, or, (2) there is absence of donor cells in the marrow and/or blood as demonstrated by chimerism assay in the absence of relapse, a diagnosis of secondary graft failure is made. The patient is not evaluable for graft failure o
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Busulfan
- DRUG Anti-Thymocyte Globulin (Rabbit)
- DEVICE The CliniMACS device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2018-05-15 |
| Est. Completion | 2021-04-09 |
| Phase | Phase 2 |
Why NCT03600909 stopped before completion
NCT03600909 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03600909 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03600909 about?
NCT03600909 is a clinical study titled "A Study of the Effect of Blood Stem Cell Transplant After Chemotherapy Alone in Patients With Fanconi Anemia". The goal of this study is to see if the study therapy can decrease the chemotherapy-related side effects while maximizing the effectiveness of disease control. The physicians will also be studying the effect of removing T-cells from the donor"s stem cells before transplant. T-cells are a type of whi...
What is the current status of trial NCT03600909?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2018-05-15. Estimated completion is 2021-04-09.
What interventions are being tested in trial NCT03600909?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Busulfan (DRUG), Anti-Thymocyte Globulin (Rabbit) (DRUG), The CliniMACS device (DEVICE).
Who is sponsoring clinical trial NCT03600909?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03600909's enrollment target sits among peer trials
3 2001st of 2000 the lowest 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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