Home › Blood Disorders › NCT06828796
Early Use of Tacrolimus in HLA-Mismatched Haploidentical Allogeneic Hematopoietic Transplantation With Post-Transplant Cyclophosphamide
RecruitingPhase 2
Who can join
Ages 18 to 80 · All sexes
Full eligibility criteria
Inclusion Criteria: * Availability of a 5/10-8/10 mismatched (HLA-A, B, DR) haploidentical related donor with a negative HLA cross-match in the host vs. graft direction and willing to provide peripheral blood stem cells * Karnofsky status \>/= 70% * Hematologic malignancy requiring allogeneic transplantation * First allogeneic transplant only. Prior autologous transplant is allowed. Exclusion Criteria: * Poor cardiac function: LVEF \<40% * Poor pulmonary function: FEV1 and FVC \<50% predicted * Poor liver function: bilirubin \>/= 3mg/dL (not due to hemolysis, Gilbert's or primary malignancy) * Poor renal function: Creatinine \>/= 2mg/dL or creatinine clearance (calculated or measured creatinine clearance is permitted) \<40mL/min based on Traditional Cockcroft-Gault formula * Women of childbearing potential who currently are pregnant or who are not practicing adequate contraception * Patients who have any debilitating medical or psychiatric illness that would preclude their giving informed consent or their receiving optimal treatment and follow up
About the study
To evalute the safety and efficacy in reducing Cytokine Release Syndrome after hematopoietic stem cell transplantation by introducing immunosuppression earlier in the transplant process
What is being tested
- Tacrolimus (drug)
- Cyclophosphamide (drug)
- Mycofenolate mofetil (drug)
Sponsor: Northside Hospital, Inc. · Participants: 20 · Started: Jul 3, 2025
Contact the study team
- Melh Solh, MD · Phone: 404-255-1930
- Caitlin Guzowski, MBA, MHA, CCRC · Phone: 404-851-8523
Official record on ClinicalTrials.gov — NCT06828796
Locations in the U.S.
| Georgia | Northside Hospital, Atlanta |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.