Early tacrolimus in HLA-mismatched haploidentical blood stem-cell transplant with post-transplant cyclophosphamide
Official title: Early Use of Tacrolimus in HLA-Mismatched Haploidentical Allogeneic Hematopoietic Transplantation With Post-Transplant Cyclophosphamide
Run by Northside Hospital, Inc. · NCT06828796 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Northside Hospital, Inc. Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Status | Recruiting |
| Started | July 3, 2025 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2028 |
| Registry record updated | October 14, 2026 |
| Trial ID | NCT06828796 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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%.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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).
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.