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NCT Number: NCT06828796

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

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

Recruiting

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Key information

Conditions

Hematologic Disease and Disorders Disease Hematologic Diseases Hematopoietic Cell Transplant Hemic and Lymphatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location status: Recruiting

Location contact

Caitlin Guzowski, MBA, MHA, CCRC

CONTACT

[email protected]

404-851-8523

Melhem Solh, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Caitlin Guzowski, MBA, MHA, CCRC

CONTACT

[email protected]

404-851-8523

Melh Solh, MD

CONTACT

[email protected]

404-255-1930

Sponsors and collaborators

Lead sponsor

Northside Hospital, Inc.

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 14, 2025
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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