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NCT02793544 · ClinicalTrials.gov registry record · Phase 2
HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide
A Phase 2 study of Chronic Lymphocytic Leukemia (CLL) and Myelodysplastic Syndrome (MDS), sponsored by Center for International Blood and Marrow Transplant Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 11
- Study locations
NCT02793544: Completed Phase 2 study of Chronic Lymphocytic Leukemia (CLL) and Myelodysplastic Syndrome (MDS), sponsored by Center for International Blood and Marrow Transplant Research.
NCT02793544 is a Phase 2 study of Chronic Lymphocytic Leukemia (CLL) and Myelodysplastic Syndrome (MDS) that has completed, run by Center for International Blood and Marrow Transplant Research. The registered enrollment target is 80 participants, below the 189-participant average among 29 other Chronic Lymphocytic Leukemia (CLL) trials with a reported enrollment target (58% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02793544, a Phase 2 study of Chronic Lymphocytic Leukemia (CLL) and Myelodysplastic Syndrome (MDS), has completed, sponsored by Center for International Blood and Marrow Transplant Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 11
- Study locations
Study Summary
This is a multi-center, single arm Phase II study of hematopoietic cell transplantation (HCT) using human leukocyte antigen (HLA)-mismatched unrelated bone marrow transplantation donors and post-transplantation cyclophosphamide (PTCy), sirolimus and mycophenolate mofetil (MMF) for graft versus host disease (GVHD) prophylaxis in patients with hematologic malignancies.
Primary Outcome
Death from any cause. The time to this event is the time from HCT to death, loss to follow-up, or end of study (whichever comes first). The overall survival probability and 90% CI will be calculated by the Kaplan Meier product limit estimator.
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Busulfan
- DRUG Cyclophosphamide 14.5 mg/kg/day IV on Days -6, -5
- RADIATION Total Body Irradiation (TBI) 200cGy on Day -1
- PROCEDURE Infusion of non-T-cell depleted bone marrow on Day 0
Study Locations (11)
Florida
- Shands HealthCare & University of Florida - Gainesville
- University of Miami - Miami
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Maryland
- University of Maryland Greenebaum Cancer Center - Baltimore
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
Michigan
- Karmanos Cancer Institute - Detroit
New York
- Memorial Sloan Kettering Cancer Center - Adults - New York
North Carolina
- University of North Carolina Hospitals - Chapel Hill
Ohio
- Ohio State Medical Center, James Cancer Center - Columbus
Virginia
- Virginia Commonwealth University Massey Cancer Center Bone Marrow Transplant Program - Richmond
Wisconsin
- Froedtert Memorial Lutheran Hospital - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2016-12 |
| Est. Completion | 2020-03 |
| Phase | Phase 2 |
What the finished NCT02793544 record still lists
NCT02793544 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 189-participant average among 29 other Chronic Lymphocytic Leukemia (CLL) trials with a reported enrollment target (58% lower).
The record links to 7 conditions, with Chronic Lymphocytic Leukemia (CLL) appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.
NCT02793544 lists 11 locations in 8 states (Florida, Maryland, Michigan).
Frequently Asked Questions
What is clinical trial NCT02793544 about?
NCT02793544 is a clinical study titled "HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide". This is a multi-center, single arm Phase II study of hematopoietic cell transplantation (HCT) using human leukocyte antigen (HLA)-mismatched unrelated bone marrow transplantation donors and post-transplantation cyclophosphamide (PTCy), sirolimus and mycophenolate mofetil (MMF) for graft versus host ...
What is the current status of trial NCT02793544?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2016-12. Estimated completion is 2020-03.
What conditions does trial NCT02793544 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia (CLL), Myelodysplastic Syndrome (MDS), Acute Myelogenous Leukemia (AML), Chemotherapy-sensitive Lymphoma, Acute Lymphoblastic Leukemia (ALL)/T Lymphoblastic Lymphoma.
What interventions are being tested in trial NCT02793544?
The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), Cyclophosphamide 14.5 mg/kg/day IV on Days -6, -5 (DRUG), Total Body Irradiation (TBI) 200cGy on Day -1 (RADIATION), Infusion of non-T-cell depleted bone marrow on Day 0 (PROCEDURE).
Who is sponsoring clinical trial NCT02793544?
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 NCT02793544 being conducted?
This trial has 11 study locations across Florida, Maryland, Michigan, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia (CLL)
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 NCT02793544's enrollment target sits among peer trials
80 15th of 29 higher than 15 of 29 other Chronic Lymphocytic Leukemia (CLL) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia (CLL) 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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