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NCT03159702 · ClinicalTrials.gov registry record · Phase 2
Propylene Glycol-Free Melphalan HCl (EVOMELA®) in Combination With Fludarabine and Total Body Irradiation Based Reduced Intensity Conditioning for Haploidentical Transplantation
A Phase 2 study, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT03159702: Completed Phase 2 study, sponsored by Medical College of Wisconsin.
NCT03159702 is a Phase 2 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03159702, a Phase 2 study, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
This is an open-label, single-arm, phase II study to determine the safety of propylene glycol-free melphalan HCl (EVOMELA®), in combination with fludarabine and total-body irradiation-based reduced-intensity conditioning for haploidentical transplantation. In addition, the study evaluates the one-year progression-free survival of patients undergoing this treatment.
Primary Outcome
Progression-free survival (PFS) is defined as the interval from the date of transplantation to the earlier of the following events: (1) the first documented objective disease progression; (2) death from any cause. Subjects without documented PD/death will be censored at the earliest of the of the following times: (1) the starting time of a new treatment other than the study treatment; (2) the last efficacy assessment date.
Interventions
- DRUG Fludarabine
- RADIATION Total Body Irradiation
- DRUG Evomela
- OTHER Haploidentical Hematopoietic Cell Transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2017-12-08 |
| Est. Completion | 2025-12-08 |
| Phase | Phase 2 |
What the finished NCT03159702 record still lists
NCT03159702 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 4 interventions - of which Fludarabine is the first listed.
NCT03159702 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03159702 about?
NCT03159702 is a clinical study titled "Propylene Glycol-Free Melphalan HCl (EVOMELA®) in Combination With Fludarabine and Total Body Irradiation Based Reduced Intensity Conditioning for Haploidentical Transplantation". This is an open-label, single-arm, phase II study to determine the safety of propylene glycol-free melphalan HCl (EVOMELA®), in combination with fludarabine and total-body irradiation-based reduced-intensity conditioning for haploidentical transplantation. In addition, the study evaluates the one-ye...
What is the current status of trial NCT03159702?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2017-12-08. Estimated completion is 2025-12-08.
What interventions are being tested in trial NCT03159702?
The interventions under investigation include: Fludarabine (DRUG), Total Body Irradiation (RADIATION), Evomela (DRUG), Haploidentical Hematopoietic Cell Transplantation (OTHER).
Who is sponsoring clinical trial NCT03159702?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03159702's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 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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