Recruiting
Phase 2

Immunosuppression

Sponsor:

Northside Hospital, Inc.

Code:

NCT06828796

Conditions

Hematologic Disease and Disorders

Hematopoietic Cell Transplant

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tacrolimus

Cyclophosphamide

Mycofenolate mofetil

Study Details

Brief summary:

To evalute the safety and efficacy in reducing Cytokine Release Syndrome after hematopoietic stem cell transplantation by introducing immunosuppression earlier in the transplant process

Conditions

Hematologic Disease and Disorders

Hematopoietic Cell Transplant

Study ID

NCT06828796

Start date

Jul 3, 2025

Status verified date

Apr, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Tacrolimus

Begins Day -1 and continues to Day +90 or Day +180 after transplant

Cyclophosphamide

Given Days +3 and +4 after transplant

Mycofenolate mofetil

Given Day 0 to Day +35 after transplant

Primary outcome measure

  • Efficacy in preventing CRS post transplant [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Melh Solh, MD

404-255-1930msolh@bmtga.com

Caitlin Guzowski, MBA, MHA, CCRC

404-851-8523caitlin.guzowski@northside.com

Locations

Northside Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Caitlin Guzowski, MBA, MHA, CCRC

404-851-8523caitlin.guzowski@northside.com

Principal Investigator:

Melhem Solh, MD

More Information

Sponsor

Northside Hospital, Inc.

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northside Hospital, Inc. on 2026-04-16.