Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
ID06828796

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

Led by Northside Hospital, Inc. · Updated on 2026-04-16

20

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how introducing immunosuppression earlier during hematopoietic stem cell transplantation affects the safety and effectiveness in reducing Cytokine Release Syndrome (CRS) in patients with hematologic diseases who receive mismatched haploidentical transplants. This Phase 2 study evaluates the use of specific drugs in transplant patients to better understand how to prevent this serious immune reaction after transplant. The study treatment includes giving cyclophosphamide on days +3 and +4 after transplantation, tacrolimus starting one day before transplant and continuing until day +90 or day +180, and mycophenolate mofetil from day 0 to day +35 after transplant. These medications aim to suppress the immune system to reduce complications. All participants receive this same combination of drugs during the study. Participants will be closely monitored for 30 days to assess the prevention and severity of CRS. Safety of the early immunosuppression approach will be evaluated at 6 months and 1 year. Assessments include clinical monitoring and laboratory tests to track patient health and treatment effects. The study runs through 2028, and participant involvement includes regular visits and follow-up over this period to measure outcomes and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 �3D 70%
  • Hematologic malignancy requiring allogeneic transplantation
  • First allogeneic transplant only. Prior autologous transplant is allowed.
Not Eligible

You will not qualify if you...

  • Poor cardiac function: LVEF <40%
  • Poor pulmonary function: FEV1 and FVC <50% predicted
  • Poor liver function: bilirubin �3D 3mg/dL (not due to hemolysis, Gilbert's or primary malignancy)
  • Poor renal function: Creatinine �3D 2mg/dL or creatinine clearance <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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - From Day -1 to Day +90 or Day +180 after transplant

Participants receive Tacrolimus starting the day before transplant and continuing up to Day +90 or Day +180. Cyclophosphamide is given on Days +3 and +4 after transplant, and Mycophenolate mofetil is administered from Day 0 to Day +35 after transplant.

Trial Site Locations

Total: 1 location

1

Northside Hospital

Atlanta, Georgia, United States, 30342

Actively Recruiting

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Research Team

M

Melh Solh, MD

C

Caitlin Guzowski, MBA, MHA, CCRC

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Fevers post infusion of T-cell replete hla mismatched haploidentical hematopoietic stem cells with post-transplant cyclophosphamide: risk factors and impact on transplant outcomes.

Melhem M Solh, Elizabeth Dickhaus, Scott R Solomon...

https://pubmed.ncbi.nlm.nih.gov/30953027

Reduced Cytokine Release Syndrome and Improved Outcomes with Earlier Immunosuppressive Therapy in Haploidentical Stem Cell Transplantation.

Jerrica Tang, Ryan R Jensen, Baylee Bryan...

https://pubmed.ncbi.nlm.nih.gov/38281591

Cytokine release syndrome after haploidentical hematopoietic cell transplantation: an international multicenter analysis.

Ramzi Abboud, Fei Wan, Jacopo Mariotti...

https://pubmed.ncbi.nlm.nih.gov/34262142

Severe Cytokine-Release Syndrome after T Cell-Replete Peripheral Blood Haploidentical Donor Transplantation Is Associated with Poor Survival and Anti-IL-6 Therapy Is Safe and Well Tolerated.

Ramzi Abboud, Jesse Keller, Michael Slade...

https://pubmed.ncbi.nlm.nih.gov/27318038

Timing of Post-Transplantation Cyclophosphamide Administration in Haploidentical Transplantation: A Comparative Study on Behalf of the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation.

Annalisa Ruggeri, Myriam Labopin, Giorgia Battipaglia...

https://pubmed.ncbi.nlm.nih.gov/32645444

A Modified Post-Transplant Cyclophosphamide Regimen, for Unmanipulated Haploidentical Marrow Transplantation, in Acute Myeloid Leukemia: A Multicenter Study.

Patrizia Chiusolo, Gesine Bug, Attilio Olivieri...

https://pubmed.ncbi.nlm.nih.gov/29421292

T-cell-replete HLA-haploidentical hematopoietic transplantation for hematologic malignancies using post-transplantation cyclophosphamide results in outcomes equivalent to those of contemporaneous HLA-matched related and unrelated donor transplantation.

Asad Bashey, Xu Zhang, Connie A Sizemore...

https://pubmed.ncbi.nlm.nih.gov/23423745