Study on MUC1 Inhibitor GO-203-2C for Treating Relapsed or Resistant Acute Myeloid Leukemia

Sponsor: Beth Israel Deaconess Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02204085

Provider View

This clinical trial is testing a new targeted therapy called GO-203-2C, alone and with another drug, decitabine, to treat patients with acute myeloid leukemia (AML) that has returned or not responded to treatment.

Patient Parameters

Program Overview

The study is exploring a new treatment called GO-203-2C for patients with acute myeloid leukemia (AML). This treatment aims to target cancer cells while sparing healthy ones. The trial is in two phases: Phase I focuses on finding the safest dose of GO-203-2C, both alone and with decitabine, while Phase II aims to see if the combination of these drugs can effectively treat AML.

Description

The study is divided into two phases:

  • Phase I: This phase aims to find the highest dose of GO-203-2C that can be given safely to patients with AML without causing severe side effects. Participants will receive different doses based on how previous participants have responded. The study will also test the combination of GO-203-2C with another drug, decitabine, to find the safest dose.

  • Phase II: The main goal here is to determine if the combination of GO-203-2C and decitabine can effectively treat AML by observing the patients' responses to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with acute myeloid leukemia (AML), excluding a specific type called acute promyelocytic leukemia (APL).
  • AML that has not responded to initial treatment, has returned, or if the patient is 60 years or older and not suitable for standard treatment due to age or health factors.
  • Age 18 or older.
  • Good overall health with a performance status score of at least 50%.
  • Expected to live at least 6 more weeks.
  • Able to understand the study and willing to sign a consent form.
  • Adequate liver and kidney function based on specific blood test results.
  • Negative pregnancy test for women who can have children.
  • Agree to use effective birth control during the study.

Exclusion Criteria

  • Leukemia affecting the brain or spinal cord.
  • Uncontrolled high blood pressure.
  • Severe heart disease or recent heart attack.
  • Active infections requiring treatment.
  • Known HIV infection.
  • Recent major surgery or not fully recovered from surgery.
  • Recent use of other experimental treatments or anti-leukemia therapies.
  • Pregnant or breastfeeding women.
  • Unable or unwilling to follow study requirements.

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