Study on Cladribine-Based Chemotherapy for Treating Relapsed or Hard-to-Treat Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome

Sponsor: Medical College of Wisconsin

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03150004

Provider View

This clinical trial is testing a cladribine-based chemotherapy treatment for patients with relapsed or difficult-to-treat acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The study aims to understand how effective this treatment is and how it affects patients' survival.

Patient Parameters

Program Overview

This study is being conducted at the Medical College of Wisconsin to test a chemotherapy treatment using cladribine for patients with relapsed or hard-to-treat acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). Researchers want to see if this treatment can help patients achieve remission and improve their survival. They will also study how patients' genetic makeup might affect their response to the treatment and any side effects they experience.

Description

The study is exploring a chemotherapy treatment using cladribine for patients with relapsed or hard-to-treat acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The goal is to find out if this treatment can help patients achieve remission, where no signs of cancer are found, and improve their overall survival. Researchers will also look at how patients' genetic information might influence their response to the treatment and any side effects they experience.

The study will measure how many patients achieve complete remission and whether they have no minimal residual disease (MRD), which means no remaining cancer cells can be detected. It will also track patients' progression-free survival (how long they live without the cancer getting worse) and overall survival.

Participants will be monitored at regular intervals to assess the treatment's effectiveness and safety. The study will also explore which factors might predict a better response to the treatment, including genetic factors.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Have a confirmed diagnosis of:
    • Primary Acute Myeloid Leukemia (AML)
    • AML that developed from Myelodysplastic Syndrome (MDS) or myeloproliferative neoplasm (MPN)
    • Therapy-related AML (t-AML)
    • High-risk MDS after failing hypomethylating agents
  • Be in relapse or have refractory disease, with or without prior stem cell transplant, or have MDS or MPN that transformed to AML.
  • Have an ECOG performance score of 0 to 3, indicating varying levels of activity.
  • Agree to use effective contraception during and after the study to prevent pregnancy.
  • Be able to understand and sign a consent form.
  • Meet specific blood and organ function criteria, such as:
    • Neutrophil count and platelet levels above certain thresholds unless related to AML
    • Liver and kidney function within specified limits
    • Heart function with an ejection fraction of at least 45%

Exclusion Criteria

  • Have Acute Promyelocytic Leukemia.
  • Have an active infection not well controlled by treatment.
  • Be pregnant or breastfeeding.
  • Be participating in other clinical trials with investigational agents not included in this study.

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