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NCT03342196 · ClinicalTrials.gov registry record · Phase 2
Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation
A Phase 2 study of Leukemia, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT03342196: Completed Phase 2 study of Leukemia, sponsored by Case Comprehensive Cancer Center.
NCT03342196 is a Phase 2 study of Leukemia that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 40 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03342196, a Phase 2 study of Leukemia, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
In the United States, thiotepa has been utilized in reduced intensity conditioning regimens for alternative donor courses (double umbilical cord blood transplant (dUCBT) and haplo-identical transplants). The hypothesis is that thiotepa at a dose of 10mg/kg, in combination with melphalan (100mg/m2) and fludarabine (160mg/m2) as a reduced intensity conditioning regimen for alternative donor transplant is safe and effective in patients with hematologic malignancies. Given that this regimen has been investigated extensively, and the current study proposes to confirm those previous observations with a small modification (melphalan dose reduction due to previous mucositis rates with higher doses), this will be a phase II study designed to measure disease-free-survival.
Primary Outcome
Leukemia Free Survival (LFS) at 1 year is the percentage of patients alive and without evidence of hematologic malignancy at 1 year after transplant.
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Melphalan
- DRUG Thiotepa
Study Locations (1)
Ohio
- University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-03-21 |
| Est. Completion | 2024-06-12 |
| Phase | Phase 2 |
What the finished NCT03342196 record still lists
NCT03342196 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 487-participant average among 233 other Leukemia trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Fludarabine is the first listed.
NCT03342196 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT03342196 about?
NCT03342196 is a clinical study titled "Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation". In the United States, thiotepa has been utilized in reduced intensity conditioning regimens for alternative donor courses (double umbilical cord blood transplant (dUCBT) and haplo-identical transplants). The hypothesis is that thiotepa at a dose of 10mg/kg, in combination with melphalan (100mg/m2) ...
What is the current status of trial NCT03342196?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2018-03-21. Estimated completion is 2024-06-12.
What conditions does trial NCT03342196 study?
This clinical trial studies the following conditions: Leukemia.
What interventions are being tested in trial NCT03342196?
The interventions under investigation include: Fludarabine (DRUG), Melphalan (DRUG), Thiotepa (DRUG).
Who is sponsoring clinical trial NCT03342196?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03342196 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03342196's enrollment target sits among peer trials
40 130th of 233 higher than 95 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leukemia 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.
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