Study on Propylene Glycol-Free Melphalan HCl (EVOMELA®) with Fludarabine and Radiation for Transplant Preparation

Sponsor: Medical College of Wisconsin

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03159702

Provider View

This clinical trial is testing a new treatment approach using EVOMELA®, a propylene glycol-free form of melphalan, combined with fludarabine and radiation therapy to prepare patients for a type of stem cell transplant from a partially matched donor.

Patient Parameters

Program Overview

This study aims to evaluate the safety of using EVOMELA®, a propylene glycol-free version of melphalan, in combination with fludarabine and total-body irradiation to prepare patients for a haploidentical stem cell transplant. The study will also assess how well patients do one year after the treatment, focusing on whether their cancer stays under control.

Description

This study is designed for older or less healthy patients with blood cancers who need a stem cell transplant but cannot tolerate the usual high-intensity treatments. The trial uses a gentler approach called reduced-intensity conditioning (RIC), which includes the drugs fludarabine and melphalan, along with radiation therapy.

Fludarabine helps the body accept donor cells, while melphalan fights cancer and suppresses the immune system. The study uses a special form of melphalan called EVOMELA®, which does not contain propylene glycol, a substance that can cause side effects. This new formulation may allow for higher doses of melphalan, potentially improving cancer control after the transplant.

The study will test the safety and effectiveness of this treatment combination in patients receiving a transplant from a partially matched family member. Researchers hope this approach will provide a safer and more effective option for patients who cannot undergo traditional high-intensity treatments.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with blood cancers who are receiving a stem cell transplant from a partially matched family member.
  • Must have normal liver function, with bilirubin levels within specified limits.
  • Must have adequate kidney function, with a creatinine clearance above 30 mL/min.
  • Heart function must be sufficient, with a left ventricular ejection fraction of at least 40%.
  • Lung function must be adequate, with specific breathing test results at or above 50% of predicted values.
  • Must have a performance status score above 60, indicating the ability to carry out daily activities.
  • Must provide a tumor sample from a liver metastasis before starting treatment.
  • Women of childbearing potential must have a negative pregnancy test and agree to use two effective methods of contraception during and after the study.
  • Men must agree to use effective barrier contraception or practice abstinence during and after the study.
  • No active infections at the time of enrollment.
  • Must be able to provide informed consent.
  • Must have a partially matched family donor with specific genetic markers.

Exclusion Criteria

  • Cannot have a fully matched sibling or unrelated donor available.
  • No serious medical or psychiatric conditions that could interfere with the study.
  • Cannot have active leukemia or lymphoma, defined as more than 5% cancer cells in the bone marrow or active disease in the central nervous system.

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