Actively Recruiting

Phase 2
Age: 60Years +
All Genders
ID06799195

A Phase II Randomized Trial to Optimize GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation in Older Adults With Hematological Malignancies: the PROMISE Trial

Led by University of Nebraska · Updated on 2025-12-15

126

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the effects of different doses of post-transplant cyclophosphamide on health-related quality of life in older adults undergoing allogeneic hematopoietic stem cell transplantation for hematological malignancies. This phase II study compares a standard high dose with a lower, attenuated dose, both combined with two-drug graft-versus-host disease (GVHD) prevention. The goal is to understand how these regimens impact patients' recovery and wellbeing after transplant. Participants are randomly assigned to receive either high-dose cyclophosphamide (50 mg/kg) or attenuated-dose cyclophosphamide (25 mg/kg) on days +3 and +4 after transplant. Both groups also receive sirolimus and mycophenolate mofetil (MMF) starting on day +5 for GVHD prevention, with sirolimus dosing adjusted over time and MMF typically stopped by day +35 if no GVHD occurs. The study involves 126 participants, split evenly between the two treatment plans. During the study, participants will be closely monitored for changes in quality of life using the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) tool, as well as functional status, physical abilities, frailty, depression, and GVHD symptoms. Researchers will track survival, relapse, toxicities, and complications for up to one year post-transplant. Assessments include clinical scales, physical tests, and medical evaluations to understand the effects of each treatment approach on recovery and health outcomes.

CONDITIONS

Brief Title

Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 60 years or older
  • Diagnosis of a hematological malignancy or other serious hematological disorder requiring allogeneic hematopoietic cell transplantation
  • Planned to receive any reduced-intensity conditioning regimen with an HLA-matched donor at HLA loci A, B, C, and DRB1
  • Karnofsky Performance Status (KPS) of 70% or higher
Not Eligible

You will not qualify if you...

  • Previous history of one or more prior allogeneic stem cell transplants
  • Planned use of high doses of cyclophosphamide (around 50 mg/kg or more) as part of the conditioning regimen before transplant
  • Known liver cirrhosis or advanced liver disease affecting cyclophosphamide metabolism
  • Diagnosis of myelofibrosis
  • Creatinine clearance less than 40 mL/min/1.73 m²
  • Systolic cardiac dysfunction with ejection fraction below 45%
  • Use of a haploidentical or mismatched donor
  • Any condition increasing risk of toxicities related to post-transplant cyclophosphamide as judged by physician

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From day 0 (transplant) to day +35 post-transplant

Participants receive either attenuated-dose or high-dose post-transplant cyclophosphamide on days +3 and +4 after allogeneic hematopoietic stem cell transplantation, along with sirolimus and mycophenolate mofetil for graft-versus-host disease prophylaxis.

Visits on days +3, +4, +5, and regular visits up to day +35

Follow-up

Duration - Up to 1 year post-transplant

Participants are monitored for health-related quality of life, functional outcomes, graft-versus-host disease, relapse, survival, and toxicities up to 1 year post-transplant.

Regular visits with assessments at 3 months, 6 months, and 1 year post-transplant

Trial Site Locations

Total: 1 location

1

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Actively Recruiting

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Research Team

T

Taylor Johnson

I

IIT OFFICE

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Randomized Phase III BMT CTN Trial of Calcineurin Inhibitor-Free Chronic Graft-Versus-Host Disease Interventions in Myeloablative Hematopoietic Cell Transplantation for Hematologic Malignancies.

Leo Luznik, Marcelo C Pasquini, Brent Logan...

https://pubmed.ncbi.nlm.nih.gov/34855460

Lethal graft-versus-host disease after bone marrow transplantation across minor histocompatibility barriers in mice. Prevention by removing mature T cells from marrow.

R Korngold, J Sprent

https://pubmed.ncbi.nlm.nih.gov/363972

Quality of life measurement in bone marrow transplantation: development of the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale.

R P McQuellon, G B Russell, D F Cella...

https://pubmed.ncbi.nlm.nih.gov/9051246