Study on Improving GVHD Prevention After Stem Cell Transplant

Sponsor: University of Nebraska

Sponsor score: 40

ClinicalTrials ID:NCT06799195

This clinical trial is exploring whether using a lower dose of a drug called cyclophosphamide, along with standard medications, can improve the quality of life for patients after a stem cell transplant.

Patient Parameters

Parameter	Options

Program Overview

The study aims to find out if using a lower dose of cyclophosphamide, a drug given after a stem cell transplant, can help improve the quality of life for patients. It will compare the effects of standard high doses versus lower doses of this drug, along with other medications, in preventing a condition called graft-versus-host disease (GVHD).

Description

This study involves 126 participants who have blood cancers or serious blood disorders and are receiving a stem cell transplant from a donor. Participants will be randomly assigned to receive either a high dose or a lower dose of cyclophosphamide, in addition to two other medications to prevent GVHD. The study will monitor participants' quality of life, daily functioning, and any side effects or complications. Researchers will use various tests and scales to assess these outcomes, including how well participants can perform daily activities, their mental health, and any signs of GVHD or cancer relapse.

Eligibility Criteria

Inclusion Criteria

Adults aged 60 years or older.
Have a blood cancer or serious blood disorder that requires a stem cell transplant from a donor.
Plan to receive a specific type of pre-transplant treatment and have a donor who is a good match.
Be in relatively good health, with a performance status of 70% or higher, meaning able to care for oneself with some help.

Exclusion Criteria

Have had one or more previous stem cell transplants from a donor.
Plan to use high doses of cyclophosphamide as part of the pre-transplant treatment.
Have severe liver disease that affects how the body processes cyclophosphamide.
Have a condition called myelofibrosis.
Have poor kidney function, which could increase the risk of side effects from cyclophosphamide.
Have heart problems with an ejection fraction below 45%.
Plan to use a donor who is not a close match.
Have any other condition that the doctor believes could increase the risk of side effects from the treatment.

Locations

FACILITY	ZIP	CITY	STATE
University of Nebraska Medical Center	68198	Omaha	Nebraska

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