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NCT06001385 · ClinicalTrials.gov registry record · Phase 2
HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation With Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis
A Phase 2 study of Lymphoma and Acute Myeloid Leukemia, sponsored by Center for International Blood and Marrow Transplant Research.
- Active
- Registry status
- Phase 2
- Development phase
- 313
- Enrollment target
- 20
- Study locations
NCT06001385: Active Phase 2 study of Lymphoma and Acute Myeloid Leukemia, sponsored by Center for International Blood and Marrow Transplant Research.
NCT06001385 is a Phase 2 study of Lymphoma and Acute Myeloid Leukemia that is active but no longer recruiting, run by Center for International Blood and Marrow Transplant Research. The registered enrollment target is 313 participants, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (35% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06001385, a Phase 2 study of Lymphoma and Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by Center for International Blood and Marrow Transplant Research.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 313 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this clinical trial is to determine the effectiveness of Reduced Dose Post-Transplant Cyclophosphamide (PTCy) in patients with hematologic malignancies after receiving an HLA-Mismatched Unrelated Donor (MMUD) . The main question\[s\] it aims to answer are: * Does a reduced dose of PTCy reduce the occurrence of infections in the first 100 days after transplant? * Does a reduced dose of PTCy maintain the same level of protection against Graft Versus Host Disease (GvHD) as the standard dose of PTCy?
Primary Outcome
Survival at 100 days without grades 2-3 infections (per BMT CTN grading criteria)
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Busulfan
- DRUG Mesna
- PROCEDURE PBSC Hematopoietic Stem Cell Transplantation (HSCT)
- DRUG Post-Transplant Cyclophosphamide
Study Locations (20)
California
- City of Hope - Duarte
- University of California San Francisco - San Francisco
- Stanford University - Stanford
Florida
- Mayo Clinic Jacksonville - Jacksonville
- University of Miami Sylvester Cancer Center - Miami
- Moffitt Cancer Center - Tampa
Arizona
- Mayo Clinic Arizona - Phoenix
- Honor Health - Scottsdale
Massachusetts
- Tufts University - Boston
- Dana Farber Cancer Institute - Boston
Minnesota
- University of Minnesota - Minneapolis
- Mayo Clinic - Rochester
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Colorado
- Colorado Blood Cancer Institute at Presbyterian St. Luke's - Denver
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 313 participants |
| Start Date | 2023-12-08 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
What the registry record for NCT06001385 still lists
NCT06001385 is an interventional study that assigns participants to a tested intervention. The registered 313 participants enrollment target is mid-sized for trials with a published cap, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (35% lower).
The record links to 10 conditions, with Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.
NCT06001385 names 20 study sites across 13 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06001385 about?
NCT06001385 is a clinical study titled "HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation With Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis". The goal of this clinical trial is to determine the effectiveness of Reduced Dose Post-Transplant Cyclophosphamide (PTCy) in patients with hematologic malignancies after receiving an HLA-Mismatched Unrelated Donor (MMUD) . The main question\[s\] it aims to answer are: * Does a reduced dose of PTCy ...
What is the current status of trial NCT06001385?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 313 participants. The study started on 2023-12-08. Estimated completion is 2026-06-30.
What conditions does trial NCT06001385 study?
This clinical trial studies the following conditions: Lymphoma, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Lymphocytic Leukemia, Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT06001385?
The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), Mesna (DRUG), PBSC Hematopoietic Stem Cell Transplantation (HSCT) (PROCEDURE), Post-Transplant Cyclophosphamide (DRUG).
Who is sponsoring clinical trial NCT06001385?
This trial is sponsored by Center for International Blood and Marrow Transplant Research, which has 29 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06001385 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. 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 NCT06001385's enrollment target sits among peer trials
313 31st of 299 higher than 269 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma 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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