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NCT01790295 · ClinicalTrials.gov registry record · Phase 2
Ruxolitinib Prior to Transplant in Patients With Myelofibrosis
A Phase 2 study, sponsored by John Mascarenhas.
- Terminated
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT01790295: Clinical Trial Phase 2 study, sponsored by John Mascarenhas.
NCT01790295 is a Phase 2 study that was terminated before completion, run by John Mascarenhas. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01790295, a Phase 2 study, was terminated before completion, sponsored by John Mascarenhas.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
The purpose of this study is to find out if giving the study drug Ruxolitinib (INC424) prior to a combination of other chemotherapeutic drugs (Fludarabine and Busulfan) before infusing another person's hematopoietic stem cells (bone marrow transplantation) will be successful in people who have advanced primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF), collectively known as myelofibrosis (MF). MF is a disorder in which bone marrow tissue develops in abnormal sites because the bone marrow itself undergoes fibrosis or scarring. This study plans to evaluate whether adding the drug Ruxolitinib will further aid in reducing pre-transplant spleen size, improve physical performance levels and reduce adverse events (side effects) related to the transplant. Ruxolitinib is a drug that is approved by the FDA for the treatment of patients with advanced forms of myelofibrosis. Using Ruxolitinib prior to stem cell transplantation is experimental.
Primary Outcome
The feasibility of combining Ruxolitinib (INC424) with a Reduced intensity conditioning (RIC) regimen likely to produce success post transplantation, success being defined as patient being alive, and without graft failure at day 100-post allogeneic stem cell transplantation (in patients who receive (a) related donor transplant and in those who receive (b) an unrelated donor transplant.
Interventions
- DRUG Ruxolitinib Pre- Hematopoietic cell transplantation (HCT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2013-11 |
| Est. Completion | 2017-10-26 |
| Phase | Phase 2 |
Why NCT01790295 stopped before completion
NCT01790295 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which Ruxolitinib Pre- Hematopoietic cell transplantation (HCT) is the first listed.
NCT01790295 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01790295 about?
NCT01790295 is a clinical study titled "Ruxolitinib Prior to Transplant in Patients With Myelofibrosis". The purpose of this study is to find out if giving the study drug Ruxolitinib (INC424) prior to a combination of other chemotherapeutic drugs (Fludarabine and Busulfan) before infusing another person's hematopoietic stem cells (bone marrow transplantation) will be successful in people who have advan...
What is the current status of trial NCT01790295?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2013-11. Estimated completion is 2017-10-26.
What interventions are being tested in trial NCT01790295?
The interventions under investigation include: Ruxolitinib Pre- Hematopoietic cell transplantation (HCT) (DRUG).
Who is sponsoring clinical trial NCT01790295?
This trial is sponsored by John Mascarenhas, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01790295's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 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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