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NCT06799195 | RECRUITING | Hematological Malignancies

Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation
Sponsor:

University of Nebraska

Brief Summary:

This study will compare post-transplant health-related quality of life following the use of standard versus attenuated dose of post-transplant cyclophosphamide in addition to two-drug graft-versus-host disease (GVHD) prophylaxis among recipients of allogeneic hematopoietic stem cell transplant.

Condition or disease

Hematological Malignancies

Graft-versus-Host Disease (GVHD)

Intervention/treatment

Attenuated-dose Cyclophosphamide

High-dose Cyclophosphamide

Sirolimus

Mycophenolate Mofetil (MMF)

Phase

PHASE2

Detailed Description:

This is a single-center phase II study of 126 participants (63 per arm) with hematological malignancies. Participants will be randomized to receive high doses (standard arm) or attenuated doses of cyclophosphamide in addition to two-drug GVHD prophylaxis. Participants will be monitored for health-related quality of life \[Functional Assessment of Cancer Therapy-Bone Marrow Transplant, FACT-BMT(1)\], functional outcomes (Karnofsky Performance Scale (KPS), activities of daily living, instrumental activities of daily living, Clock-in-the-Box Test, Fried Frailty Index, fall history, BMI, and Geriatric Depression Scale-15, GVHD, relapse, survival, and toxicities (using Common Terminology Criteria for Adverse Events, CTCAE version 5.0).

Study Type : INTERVENTIONAL
Estimated Enrollment : 126 participants
Masking : NONE
Masking Description : Not applicable; the study is open-label.
Primary Purpose : TREATMENT
Official Title : A Phase II Randomized Trial to Optimize GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation in Older Adults With Hematological Malignancies: the PROMISE Trial
Actual Study Start Date : 2025-06-23
Estimated Primary Completion Date : 2031-04
Estimated Study Completion Date : 2031-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion criteria
  • * Adults aged 60 years or older
  • * Diagnosis of a hematological malignancy or other serious hematological disorder that requires an allogeneic hematopoietic cell transplantation
  • * Planned to receive any reduced-intensity conditioning regimen (any graft source is acceptable) and availability of human leukocyte antigen (HLA)-matched donor at HLA loci A, B, C, and HLA-DR beta chain antigen (DRB1)
  • * Karnofsky Performance Status (KPS) of 70% or higher.
  • Exclusion criteria
    • * Previous history of one or more prior allogeneic stem cell transplants (i.e., second or third allogeneic transplant)
    • * Planned use of high doses of cyclophosphamide (e.g., a total cyclophosphamide dose of approximately 50 mg/kg or more) as part of the conditioning regimen prior to allogeneic stem cell transplant. A lower dose of cyclophosphamide (e.g., fludarabine, cyclophosphamide, and low-dose total body irradiation regimen that uses 2 doses of cyclophosphamide at 14.5 mg/kg) is acceptable.
    • * Known diagnosis of liver cirrhosis or other advanced liver disease that may impact cyclophosphamide metabolism.
    • * Diagnosis of myelofibrosis
    • * Creatinine clearance less than 40 mL/min/1.73 m², which may increase the risk of hemorrhagic cystitis with post-transplant cyclophosphamide (PTCy)
    • * Systolic cardiac dysfunction with an ejection fraction of less than 45%.
    • * Use of a haploidentical or mismatched donor.
    • * Any other condition judged by the physician to increase the risk of toxicities associated with PTCy.
Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation

Location Details

NCT06799195

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Locations

RECRUITING

United States, Nebraska

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198