Study on Risk-Adapted Conditioning for Stem Cell Transplantation

Sponsor: University of California, Irvine

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06028828

Provider View

This clinical trial is testing a new approach to prepare patients for stem cell transplantation by adjusting treatment based on individual risk factors. The study aims to improve safety and effectiveness for patients with certain blood cancers.

Patient Parameters

Program Overview

This study is exploring a new method for preparing patients for allogeneic stem cell transplantation, a procedure where patients receive stem cells from a donor. The preparation involves using specific medications and radiation, with doses adjusted based on the patient's risk factors and health status. The goal is to improve the safety and effectiveness of the transplant for patients with certain blood cancers.

Description

Eligible patients will undergo a stem cell transplant using a combination of medications and radiation to prepare their bodies. The treatment includes fludarabine, melphalan, and total body irradiation (TBI), with doses tailored to each patient's risk level and health status. After the transplant, patients will receive additional medications to prevent complications, such as graft-versus-host disease, which can occur when the donor's cells attack the patient's body. These medications include high-dose cyclophosphamide, tacrolimus, and mycophenolate mofetil (MMF).

The doses of melphalan and TBI will be adjusted based on factors like the patient's age, overall health, and specific risk scores. Patients will be closely monitored for safety and effectiveness of the treatment for up to two years after the transplant.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 to 70 years old.
  • Diagnosed with certain blood cancers like AML, ALL, MDS, CML, NHL, HD, or CLL that require a stem cell transplant.
  • Have a suitable donor match, which can be a related or unrelated donor, or a partially matched donor.
  • Good overall health with a performance status score above 70%.
  • Adequate organ function, including:
    • Kidney function with creatinine clearance of at least 50 ml/min.
    • Liver function with bilirubin levels within specified limits, except for Gilbert's disease.
    • Heart function with an ejection fraction of at least 40%.
    • Lung function with a specific capacity for carbon monoxide.
  • Ability to understand and sign a consent form. All genders, races, and ethnic groups are eligible, including those who are non-English speaking, deaf, or have other communication challenges.

Exclusion Criteria

  • Unable to follow medical advice or attend follow-up appointments.
  • Pregnant women.
  • Have an active or uncontrolled infection.
  • Have active disease in the central nervous system or eyes within the last 3 months.
  • Have primary central nervous system lymphoma.
  • Require changes to the standard preparation regimen for the transplant.

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