Study on the Lowest Effective Dose of Cyclophosphamide with Sirolimus and Mycophenolate Mofetil to Prevent Graft-Versus-Host Disease After Blood Stem Cell Transplant

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05436418

Provider View

This clinical trial is exploring whether a lower dose of the drug cyclophosphamide, combined with sirolimus and mycophenolate mofetil, can effectively prevent graft-versus-host disease in patients receiving blood stem cell transplants for blood cancers.

Patient Parameters

Program Overview

Blood cancers like leukemia and lymphoma can be difficult to treat with standard methods. A transplant of blood stem cells from a healthy donor can help, but it may cause a serious side effect called graft-versus-host disease (GVHD). Cyclophosphamide, given after the transplant, can reduce this risk, but it can also have side effects. This study aims to find out if a lower dose of cyclophosphamide is more effective and safer for patients undergoing blood stem cell transplants.

Description

This study is testing if a lower dose of cyclophosphamide, combined with sirolimus and mycophenolate mofetil, can prevent graft-versus-host disease (GVHD) after a blood stem cell transplant. GVHD is a common complication where the donor's immune cells attack the recipient's body. The study will test different doses of cyclophosphamide to find the lowest effective dose that prevents GVHD without causing too many side effects.

Participants will be adults with blood cancers who need a stem cell transplant. They will receive a reduced intensity conditioning treatment before the transplant, which prepares their body to accept the new stem cells. The study will have two groups: one with donors who are a partial match and another with fully matched donors.

The study will start with a small group of participants receiving the standard dose of cyclophosphamide to gather initial data. Then, it will test lower doses to find the best balance between effectiveness and safety. Participants will be monitored for signs of GVHD and other side effects for up to five years after the transplant.

Eligibility Criteria

Inclusion Criteria

  • Adults with certain blood cancers that require a stem cell transplant.
  • Age 50 or older, or 18-49 if not eligible for more intense treatment.
  • Have a suitable donor who is either a partial or full match.
  • Good overall health with adequate heart, lung, kidney, and liver function.
  • Women of childbearing potential must use effective birth control and have a negative pregnancy test before starting treatment.
  • Willingness to sign informed consent and follow study procedures.

Donor:

  • Related donor aged 12 or older, willing to donate blood, saliva, and other samples for research.

Exclusion Criteria

  • Currently receiving other experimental treatments.
  • Active breastfeeding.
  • Have another active cancer that is not a blood cancer, unless it is a non-melanoma skin cancer.
  • History of severe allergic reactions to similar drugs.
  • Have uncontrolled health issues that make the transplant unsafe.

Donor:

  • No specific exclusion criteria for donors.

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