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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Northside Hospital, Inc.
Study ID
NCT06828796
Phase
PHASE2
Status
Recruiting
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Conditions

  • Hematologic Disease and Disorders
  • Hematopoietic Cell Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Tacrolimus — DRUG
    Begins Day -1 and continues to Day +90 or Day +180 after transplant
  • Cyclophosphamide — DRUG
    Given Days +3 and +4 after transplant
  • Mycofenolate mofetil — DRUG
    Given Day 0 to Day +35 after transplant

Study Details

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

Key Dates

Start date
Jul 3, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northside HospitalAtlantaGeorgia30342
Caitlin Guzowski, MBA, MHA, CCRC
[email protected]
404-851-8523
Melhem Solh, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Northside Hospital· Atlanta, GA

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