Early tacrolimus in HLA-mismatched haploidentical blood stem-cell transplant with post-transplant cyclophosphamide
Early Use of Tacrolimus in HLA-Mismatched Haploidentical Allogeneic Hematopoietic Transplantation With Post-Transplant Cyclophosphamide
This trial tests whether starting tacrolimus earlier, together with post-transplant cyclophosphamide and mycophenolate, can reduce cytokine release syndrome in people receiving HLA-mismatched haploidentical peripheral blood stem-cell transplants.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Northside Hospital, Inc. Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT06828796 on ClinicalTrials.gov |
What this trial studies
This is a Phase 2 interventional study enrolling adults with hematologic malignancies who need a haploidentical (5/10–8/10) related donor transplant and meet organ-function and performance-status criteria. Participants receive peripheral blood stem-cell grafts with post-transplant cyclophosphamide and mycophenolate, and tacrolimus started earlier in the transplant course than usual. The trial monitors safety, incidence and severity of cytokine release syndrome, and standard transplant outcomes including engraftment and graft-versus-host disease. All treatment is delivered at a single center (Northside Hospital, Atlanta).
Who should consider this trial
Good fit: Ideal candidates are adults with a hematologic malignancy needing a first allogeneic transplant who have a willing 5/10–8/10 HLA-mismatched related donor with a negative host-vs-graft crossmatch and a Karnofsky score ≥70%.
Not a fit: Patients with significantly reduced organ function (LVEF <40%, FEV1 or FVC <50% predicted, bilirubin ≥3 mg/dL, creatinine ≥2 mg/dL or creatinine clearance <40 mL/min), current pregnancy, or other debilitating medical/psychiatric illness are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could lower the frequency and severity of cytokine release syndrome and make haploidentical transplants safer and more tolerable.
How similar studies have performed: Post-transplant cyclophosphamide–based haploidentical transplantation is an established approach that has reduced GVHD, but the specific strategy of starting tacrolimus earlier to prevent cytokine release syndrome is relatively novel with limited direct prior data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia
- Northside Hospital — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Melhem Solh, MD — The Blood and Marrow Transplant Group of Georgia
- Study coordinator: Melh Solh, MD
- Email: msolh@bmtga.com
- Phone: 404-255-1930
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.