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NCT01220297 · ClinicalTrials.gov registry record · Phase 2
Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor HCT
A Phase 2 study, sponsored by Stanford University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT01220297: Clinical Trial Phase 2 study, sponsored by Stanford University.
NCT01220297 is a Phase 2 study that was terminated before completion, run by Stanford University. 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
NCT01220297, a Phase 2 study, was terminated before completion, sponsored by Stanford University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
A continuation study of sirolimus and mycophenolate mofetil (MMF) for graft-vs-host disease (GvHD) prophylaxis for patients undergoing matched related allogeneic hematopoietic stem cell transplantation (HSCT) for acute and chronic leukemia, myelodysplastic syndrome (MDS), high risk non-Hodgkin lymphoma (NHL), or Hodgkin lymphoma (HL)
Primary Outcome
Assessed as the incidence of grade 2 to 4 acute graft-vs-host disease (GvHD) at Day 100 post-transplant. Stage of Acute GvHD was assessed as follows. * Stage 1: Skin: rash \< 25% of skin. Liver: bilirubin 2 to 3 mg/dL. Gut: diarrhea \> 500 mL/day or persistent nausea with positive biopsy for GvHD * Stage 2: Skin: rash 25 to 50% of skin. Liver: bilirubin 3 to 6 mg/dL. Gut: diarrhea \>1000 mL/day. * Stage 3: Skin: rash \> 50% of skin. Liver: bilirubin 6 to 15 mg/dL. Gut: diarrhea \> 1500 mL/day.
Interventions
- DRUG Sirolimus
- DRUG Etoposide
- DRUG Carmustine
- DRUG Mycophenolate mofetil (MMF)
- DRUG Cyclophosphamide (Cyclo, CY)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2006-08 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
Why NCT01220297 stopped before completion
NCT01220297 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 Sirolimus is the first listed.
NCT01220297 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01220297 about?
NCT01220297 is a clinical study titled "Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor HCT". A continuation study of sirolimus and mycophenolate mofetil (MMF) for graft-vs-host disease (GvHD) prophylaxis for patients undergoing matched related allogeneic hematopoietic stem cell transplantation (HSCT) for acute and chronic leukemia, myelodysplastic syndrome (MDS), high risk non-Hodgkin lymph...
What is the current status of trial NCT01220297?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2006-08. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01220297?
The interventions under investigation include: Sirolimus (DRUG), Etoposide (DRUG), Carmustine (DRUG), Mycophenolate mofetil (MMF) (DRUG), Cyclophosphamide (Cyclo, CY) (DRUG).
Who is sponsoring clinical trial NCT01220297?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01220297'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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