OncoMatch/Clinical Trials/NCT03970096
Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)
Is NCT03970096 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for acute leukemia.
Treatment: Thiotepa · Fludarabine · Tacrolimus · Allogeneic CD34+-enriched and CD45RA-depleted PBSCs · Methotrexate · Cyclophosphamide · Peripheral Blood Stem Cell · Cyclosporine · Sirolimus · Busulfan — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Prior therapy
Must have received: cytoreductive therapy (BCL-2 inhibitor, cytotoxic chemotherapy) — within past 3 months
MDS with a history of receiving cytoreductive therapy (including but not limited to BCL-2 inhibitors or cytotoxic chemotherapy) within the past 3 months
Cannot have received: myeloablative allogeneic or autologous transplantation
Patients who have received previous myeloablative allogeneic or autologous transplantation
Cannot have received: checkpoint inhibitor
Exception: unless an exception is made by the PI
Patients who have received checkpoint inhibitors within three months of transplantation unless an exception is made by the PI
Lab requirements
Kidney function
Renal insufficiency (creatinine > 1.5 mg/dl) at evaluation; if history of creatinine > 1.5 mg/dl or current serum creatinine above normal for age, must have current creatinine clearance > 60 ml/min/1.73 m^2
Liver function
LFTs (total bilirubin, AST, ALT) >= twice the upper limit of normal should be evaluated by GI physician unless clear precipitating factor; exclusion if GI physician considers HCT contraindicated; Gilbert's syndrome requires GI consultation but may be included; reversible drug-related transaminitis may be included
Cardiac function
Left ventricular ejection fraction < 45%
Patients with organ dysfunction, including: Renal insufficiency (creatinine > 1.5 mg/dl)...Left ventricular ejection fraction < 45%...LFTs (total bilirubin, AST, ALT) >= twice the upper limit of normal...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
- University of Pittsburgh Cancer Institute (UPCI) · Pittsburgh, Pennsylvania
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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