Study on Optimizing the Dose and Timing of Cyclophosphamide for Blood Cancer Transplants

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03983850

Provider View

This clinical trial is exploring whether a lower dose of the drug cyclophosphamide, used during stem cell or bone marrow transplants, can help reduce complications and improve outcomes for patients with blood cancers. The study also examines if reducing another medication, mycophenolate mofetil, can lead to fewer side effects.

Patient Parameters

Program Overview

Stem cell or bone marrow transplants can help treat blood cancers, but they come with risks. Sometimes, the donor cells attack the recipient's body, causing complications. A drug called cyclophosphamide (PTCy) is used to reduce these risks. This study is testing if a lower dose of PTCy can be just as effective, and if reducing another drug, mycophenolate mofetil, can decrease side effects. The goal is to make transplants safer and more successful for people with blood cancers.

Description

This study is investigating whether using a lower dose of cyclophosphamide (PTCy) during stem cell or bone marrow transplants can help prevent a condition called graft-versus-host disease (GVHD), where donor cells attack the recipient's body. Researchers are also looking at whether reducing the use of another drug, mycophenolate mofetil (MMF), can lead to fewer side effects while still protecting against GVHD.

Participants in the study will include people aged 15-65 with certain blood cancers, such as leukemia, lymphoma, or multiple myeloma, that are not curable with standard treatments and are at high risk of returning without a transplant. Healthy adult relatives may also participate as donors.

Transplant recipients will undergo various tests, including blood, urine, breathing, and heart tests, as well as scans and bone marrow samples. They will receive chemotherapy to prepare for the transplant and will stay in the hospital for about four weeks after receiving the stem cells. During this time, they will have blood transfusions and frequent tests.

Donors will also undergo tests and will provide either bone marrow or stem cells from their blood. Participation in the study will last up to five years.

Eligibility Criteria

Inclusion Criteria

  • Patients aged 15-65 with certain blood cancers that require a stem cell or bone marrow transplant.
  • Must have a suitable donor who is a close relative.
  • Must be in good overall health with adequate organ function.
  • Women of childbearing potential and men must agree to use effective contraception during and after the study.
  • Must be able to understand and sign a consent form.

For Donors:

  • Must be a related donor aged 12 or older, willing to donate blood, bone marrow, and other samples for research.

Exclusion Criteria

  • Patients currently receiving other experimental treatments.
  • Patients with uncontrolled illnesses or active infections.
  • Patients who have had previous myeloablative conditioning for a transplant.
  • Patients with an available HLA-matched sibling donor.
  • Pregnant or breastfeeding women.
  • Patients with active non-blood cancers that are not treatable or have been treated within the last two years.

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