Study on Venetoclax and Decitabine for Treating Relapsed or Hard-to-Treat Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03404193

Provider View

This clinical trial is exploring how well the combination of venetoclax and decitabine works in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) that has returned or is not responding to treatment. These drugs aim to stop cancer cells from growing and spreading.

Patient Parameters

Program Overview

The purpose of this study is to see if the combination of venetoclax and decitabine can effectively treat patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) that has come back or is not responding to previous treatments. Venetoclax and decitabine are chemotherapy drugs that work by killing cancer cells or stopping them from growing and spreading.

Description

The main goal of this study is to find out how many patients respond to the treatment with venetoclax and decitabine. This includes patients with AML that has not responded to previous treatments, older patients with newly diagnosed AML who cannot undergo intensive chemotherapy, and patients with high-risk MDS or chronic myelomonocytic leukemia (CMML) that has returned or not responded to previous treatments.

The study will also look at how long the response lasts, how long patients live without the disease getting worse, and overall survival rates. Researchers will assess improvements in blood counts and the safety of the treatment. They will also see how many patients can move on to stem cell transplantation after responding to the treatment.

Participants will receive decitabine through an IV for 10 days and venetoclax orally for 28 days in the first cycle, and for 21 days in the following cycles. Treatment cycles repeat every 28 days for up to 24 cycles unless the disease progresses or side effects become unacceptable.

After finishing the treatment, participants will have follow-up visits every 3 to 6 months for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Have acute myeloid leukemia (AML), blastic plasmacytoid dendritic cell neoplasm (BPDCN), or certain types of leukemia that have not responded to previous treatments or have returned.
  • Be 60 years or older with newly diagnosed AML, BPDCN, or mixed phenotype acute leukemia (MPAL) and not eligible for intensive chemotherapy.
  • Have newly diagnosed AML with specific genetic risks and be 60 years or younger.
  • Have AML or BPDCN with a history of myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) that progressed to AML.
  • Have high-risk MDS with specific bone marrow characteristics that has not responded to previous treatments.
  • Have a performance status score of 3 or lower, indicating some ability to carry out daily activities.
  • Have a white blood cell count of 10,000 or lower.
  • Have adequate kidney and liver function based on specific blood tests.
  • Agree to provide written informed consent.
  • Women must not be pregnant and must agree to use effective contraception during the study and for 3 months after the last treatment. Men must also agree to use contraception during the study and for 3 months after.

Exclusion Criteria

  • Have received any previous treatment with BCL2 inhibitors.
  • Have a specific type of leukemia known as acute promyelocytic leukemia.
  • Have active or poorly controlled central nervous system (CNS) leukemia.
  • Have uncontrolled health conditions, such as infections, high blood pressure, heart failure, or irregular heartbeats.
  • Have known infections with HIV or active hepatitis B or C.
  • Have any other medical, psychological, or social conditions that could interfere with the study or compromise safety.
  • Be pregnant or breastfeeding.

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