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Early Use of Tacrolimus in Haploidentical Transplant for Hematologic Diseases

This study is looking at whether giving the medicine tacrolimus earlier can help prevent a serious side effect called Cytokine Release Syndrome (CRS) after a stem cell transplant. You would receive tacrolimus starting the day before your transplant, along with cyclophosphamide and mycofenolate mofetil after the transplant. This study aims to see how safe and effective this approach is in reducing CRS within 30 days after your transplant. You might be able to join if you are 18 to 80 years old, need an allogeneic transplant for a blood cancer, and have a suitable related donor whose tissues are a partial match (haploidentical). The study plans to enroll 20 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 20 participants.
What's involved
You would receive tacrolimus from the day before transplant until day +90 or +180. Cyclophosphamide is given on days +3 and +4, and mycofenolate mofetil from day 0 to day +35.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome for preventing Cytokine Release Syndrome (CRS) is measured at 30 days after transplant.

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NCT06828796

Early Use of Tacrolimus in HLA-Mismatched Haploidentical Allogeneic Hematopoietic Transplantation With Post-Transplant Cyclophosphamide

Recruiting
PHASE2Ages 18–80InterventionalTreatment
Northside Hospital, Inc.
~20 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:TacrolimusCyclophosphamideMycofenolate mofetil

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy in preventing CRS post transplant
Measured over 30 days

Conditions

Hematologic Disease and Disorders
Hematopoietic Cell Transplant

Explore related trials

Hematologic Neoplasm

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Melhem Solh, MD · PRINCIPAL_INVESTIGATOR · The Blood and Marrow Transplant Group of Georgia

Who to contact

Melh Solh, MD
[email protected]
404-255-1930
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Efficacy in preventing CRS post transplant30 days

    Evaluate the incidence of CRS during the first 5 days following stem cell transplant by recording signs and symptoms based on CTCAE v5.0.