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NCT03970096 · ClinicalTrials.gov registry record · Phase 2
Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)
A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Fred Hutchinson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 3
- Study locations
NCT03970096: Recruiting Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Fred Hutchinson Cancer Center.
NCT03970096 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is actively recruiting participants, run by Fred Hutchinson Cancer Center. The registered enrollment target is 120 participants, roughly in line with the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target. The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03970096, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is actively recruiting participants, sponsored by Fred Hutchinson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II trial investigates two strategies and how well they work for the reduction of graft versus host disease in patients with acute leukemia or MDS in remission. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.
Primary Outcome
Will be defined as survival-free of a history of: a) relapse after hematopoietic cell transplantation (HCT), b) grade III-IV acute GVHD after HCT, moderate or severe chronic GVHD meeting National Institutes of Health (NIH) criteria and requiring systemic pharmacologic immunosuppression for treatment of GVHD. RFS distribution will be estimated for each arm by the Kaplan-Meier curve, starting from the time of HCT. A 90% confidence interval (CI) will be constructed at 1 and 2-year post-HCT timepoin
Conditions Studied
Interventions
- DRUG Fludarabine
- RADIATION Total-Body Irradiation
- DRUG Thiotepa
- DRUG Tacrolimus
- BIOLOGICAL Allogeneic CD34+-enriched and CD45RA-depleted PBSCs
Study Locations (3)
Florida
- Moffitt Cancer Center - Tampa
Pennsylvania
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2019-11-19 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 2 |
What NCT03970096 shows while recruiting
NCT03970096 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target.
The record links to 5 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.
NCT03970096 reports a single indexed study location in Florida, Pennsylvania, Washington.
Frequently Asked Questions
What is clinical trial NCT03970096 about?
NCT03970096 is a clinical study titled "Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)". This phase II trial investigates two strategies and how well they work for the reduction of graft versus host disease in patients with acute leukemia or MDS in remission. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cell...
What is the current status of trial NCT03970096?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2019-11-19. Estimated completion is 2029-12-31.
What conditions does trial NCT03970096 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, Myeloproliferative Neoplasm, Acute Leukemia.
What interventions are being tested in trial NCT03970096?
The interventions under investigation include: Fludarabine (DRUG), Total-Body Irradiation (RADIATION), Thiotepa (DRUG), Tacrolimus (DRUG), Allogeneic CD34+-enriched and CD45RA-depleted PBSCs (BIOLOGICAL).
Who is sponsoring clinical trial NCT03970096?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03970096 being conducted?
This trial has 3 study locations across Florida, Pennsylvania, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03970096's enrollment target sits among peer trials
120 67th of 306 higher than 238 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid 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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