RECRUITING

Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation

Description

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.

Study Overview

Study Details

Study overview

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.

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

Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation

Condition
Hematological Malignancies
Intervention / Treatment

-

Contacts and Locations

Omaha

University of Nebraska Medical Center, Omaha, Nebraska, United States, 68198

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Nebraska,

Vijaya R Bhatt, MBBS, PRINCIPAL_INVESTIGATOR, University of Nebraska

Study Record Dates

2031-11