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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03970096
The ClinicalTrials.gov registry entry for NCT03970096 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target. The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.
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