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

April 15, 2026 updated by: Northside Hospital, Inc.
To evalute the safety and efficacy in reducing Cytokine Release Syndrome after hematopoietic stem cell transplantation by introducing immunosuppression earlier in the transplant process

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Northside Hospital
        • Contact:
        • Principal Investigator:
          • Melhem Solh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tacrolimus + MMF + Post-Transplant Cyclophosphamide
Cyclophosphamide 50mg/kg/d Days +3 and +4 after transplant Tacrolimus Day -1 to Day +90 or Day +180 after transplant MMF 15mg/kg PO TID Day 0 to Day +35
Drug: Tacrolimus
Begins Day -1 and continues to Day +90 or Day +180 after transplant
Drug: Cyclophosphamide
Given Days +3 and +4 after transplant
Drug: Mycofenolate mofetil
Given Day 0 to Day +35 after transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy in preventing CRS post transplant
Time Frame: 30 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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of CRS after stem cell transplant
Time Frame: 30 days
Record incidence of CRS by grading signs and symptoms using the CTCAE v5.0, the day of onset of CRS, the duration of CRS, and admissions to the hospital for these events
30 days
Safety of administering early immunosuppression
Time Frame: 6 months
Record incidence of acute graft-versus-host disease at 6 months by using the NIH Grading Consensus system
6 months
Safety of administering early immunosuppression
Time Frame: 1 year
Record incidence of chronic graft-versus-host disease at 1 year by using the NIH Grading Consensus system
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northside Hospital, Inc.

Investigators

  • Principal Investigator: Melhem Solh, MD, The Blood and Marrow Transplant Group of Georgia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

February 14, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSH 1420

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Results of the trial will be shared on clinicaltrials.gov

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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