Study on Venetoclax and Azacitidine for Treating Therapy-Related or Secondary Myelodysplastic Syndrome

Sponsor: Uma Borate

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05379166

Provider View

This clinical trial is exploring the effects of combining two drugs, venetoclax and azacitidine, to treat patients with a specific type of blood disorder called therapy-related or secondary myelodysplastic syndrome. The study aims to see if this combination can effectively stop the growth of cancer cells.

Patient Parameters

Program Overview

This phase II study is testing how well the drugs venetoclax and azacitidine work together to treat patients with therapy-related or secondary myelodysplastic syndrome (MDS). Venetoclax may help stop cancer cells from growing by blocking a protein they need to survive. Azacitidine, a chemotherapy drug, works by killing cancer cells or stopping them from dividing and spreading. The study hopes to find out if using these two drugs together is more effective in treating this type of MDS.

Description

Primary Objective:

  • To find out how many patients achieve complete remission after treatment with azacitidine and venetoclax.

Secondary Objectives:

  • To assess the safety of the combination therapy.
  • To determine the overall response rate (ORR).
  • To measure the complete cytogenetic response rate (CCyR).
  • To find out how long the response lasts (Duration of Response, DOR).
  • To estimate event-free survival (EFS).
  • To estimate overall survival (OS).
  • To determine the rate of hematologic improvement (HIR).
  • To find out how many patients become independent of red blood cell transfusions.
  • To find out how many patients become independent of platelet transfusions.
  • To determine how many patients' disease progresses to acute myeloid leukemia (AML).
  • To find out how many patients proceed to stem cell transplantation.
  • To compare response criteria between different international guidelines.

Exploratory Objectives:

  • To study the initial frequencies of genetic changes and their relationship to treatment response.
  • To estimate progression-free survival (PFS).
  • To gather quality of life information from patient-reported questionnaires.

Treatment Plan:

Patients will take venetoclax by mouth once daily for 14 days and receive azacitidine through an IV for 7 days or 5 days in the first week and 2 days in the second week. This cycle repeats every 28 days unless the disease worsens or side effects become unacceptable. After treatment, patients will have follow-up visits at 30 days and every 6 months for up to 2 years.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand and sign a consent form.
  • Must be 18 years or older.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must have untreated therapy-related MDS with specific risk categories and less than 20% bone marrow blasts.
  • Must have had prior cancer treatment, including chemotherapy or radiation.
  • Must have specific liver and kidney function levels as determined by blood tests.
  • Must have a white blood cell count of 10,000/uL or less.
  • Women of childbearing potential must agree to use contraception during the study and for 30 days after the last dose.
  • Men must agree to use contraception during the study and for 90 days after the last dose.

Exclusion Criteria

  • Cannot have had prior treatment with venetoclax or similar drugs.
  • Cannot have other types of MDS or related blood disorders.
  • Cannot be eligible for intensive chemotherapy or stem cell transplantation without additional therapy.
  • Cannot have a history of HIV, Hepatitis B, or Hepatitis C.
  • Cannot have significant heart problems or uncontrolled illnesses.
  • Cannot have an uncontrolled infection.
  • Cannot be allergic to any study drugs.
  • Cannot have a psychiatric illness that prevents understanding the study.
  • Cannot be pregnant or breastfeeding.
  • Cannot have had a stem cell or organ transplant.
  • Cannot have another active cancer requiring treatment.
  • Cannot have taken certain medications or foods that affect drug metabolism within 7 days before the study.
  • Cannot have a condition that affects drug absorption.
  • Cannot have received a live vaccine within 4 weeks before the study.

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