Study on Reduced-Intensity Conditioning to Lower Treatment-Related Deaths in Patients Undergoing Stem Cell Transplant

Sponsor: Thomas Jefferson University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05031897

Provider View

This clinical trial is testing a new approach to reduce the risk of treatment-related deaths in patients receiving a stem cell transplant for blood cancers. The study explores using less intense radiation and chemotherapy before the transplant to see if it improves patient outcomes.

Patient Parameters

Program Overview

This study is investigating whether using a gentler approach with radiation and chemotherapy before a stem cell transplant can lower the risk of treatment-related deaths in patients with blood cancers. Stem cell transplants can cure many blood cancers, but the intense preparation often leads to higher risks. By using lower doses of radiation and chemotherapy drugs like fludarabine and cyclophosphamide, the study aims to find a safer way to prepare patients for their transplant.

Description

The main goal of this study is to see if using a reduced-intensity conditioning (RIC) approach before a stem cell transplant can lower the risk of treatment-related deaths over two years. The study also looks at how often the cancer comes back, how well the new stem cells grow, how quickly the immune system recovers, and the occurrence and severity of graft versus host disease (GVHD).

Patients are divided into two groups:

  • Radiation-Based Group: Patients receive fludarabine through an IV on specific days, undergo total-body irradiation (TBI) twice daily on certain days, receive a donor lymphocyte infusion (DLI), and get cyclophosphamide through an IV. They start taking tacrolimus and mycophenolate mofetil on the day before the transplant, which occurs on day 0. Treatment continues unless the disease progresses or side effects become unacceptable.

  • Chemotherapy-Based Group: Patients receive fludarabine and melphalan through an IV on specific days, undergo TBI and DLI once, and get cyclophosphamide through an IV. They start taking tacrolimus and mycophenolate mofetil on the day before the transplant, which occurs on day 0. Treatment continues unless the disease progresses or side effects become unacceptable.

After completing the study treatment, patients are monitored for two years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with specific blood cancers, such as acute myeloid leukemia, chronic lymphocytic leukemia, multiple myeloma, and others.
  • Have a donor who is a partial match (one-haplotype mismatched).
  • Meet specific health criteria, including heart, lung, liver, and kidney function.
  • Have a good performance status and a low score on a health index that measures other health conditions.
  • Be willing to use contraception if they can have children.
  • Be able to give informed consent.
  • Have a life expectancy of at least six months for reasons other than their blood cancer.

Exclusion Criteria

  • Have another type of cancer, except for certain skin cancers that only need local treatment.
  • Be HIV positive.
  • Have cancer affecting the central nervous system.
  • Be pregnant or breastfeeding.

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