34 Participants Needed

Venetoclax + Azacitidine for Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia

GG
Overseen ByGuillermo Garcia-Manero
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I/II trial investigates the side effects and best dose of venetoclax when given together with azacitidine and to see how well it works in treating patients with high-risk myelodysplastic syndrome or chronic myelomonocytic leukemia that has come back (relapsed) or has not responded to treatment (refractory). Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax and azacitidine together may help to control myelodysplastic syndrome or chronic myelomonocytic leukemia.

Who Is on the Research Team?

Guillermo Garcia-Manero | MD Anderson ...

Guillermo Garcia-Manero

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with high-risk myelodysplastic syndrome or chronic myelomonocytic leukemia that's resistant to treatment or has returned. They must have had previous unsuccessful therapy, be in good physical condition (ECOG/PS ≤2), and have proper liver and kidney function. Women of childbearing age need a negative pregnancy test and agree to contraception; men also must use birth control.

Inclusion Criteria

Signed written informed consent
I have CMML or therapy-related MDS that has not responded to treatment.
Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 3.0 x ULN unless considered due to leukemic involvement
See 7 more

Exclusion Criteria

I have side effects from previous cancer treatments that have not fully healed.
I have a chronic illness or allergy that may affect my participation in the study.
I have hepatitis B or C but my viral load is undetectable.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive venetoclax orally daily on days 1-14 and azacitidine intravenously or subcutaneously on days 1-5. Cycles repeat every 4-8 weeks in the absence of disease progression or unacceptable toxicity.

4-8 weeks per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-ups within 30 days and then every 3-6 months for up to 5 years.

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Azacitidine
  • Venetoclax
Trial Overview The trial is testing the combination of two drugs: Venetoclax, which may block cancer cell growth enzymes, and Azacitidine, a chemotherapy drug that kills or stops cancer cells from growing. The study aims to find the best dose and see how well these drugs work together against specific blood cancers.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (venetoclax, azacitidine)Experimental Treatment2 Interventions
Patients receive venetoclax PO daily on days 1-14 and azacitidine IV over 15 minutes or SC on days 1-5. Cycles repeat every 4-8 weeks in the absence of disease progression or unacceptable toxicity.

Azacitidine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Vidaza for:
  • Acute myeloid leukemia
  • Chronic myelomonocytic leukemia
  • Myelodysplastic syndromes
🇺🇸
Approved in United States as Vidaza for:
  • Myelodysplastic syndromes
  • Chronic myelomonocytic leukemia
🇨🇦
Approved in Canada as Vidaza for:
  • Myelodysplastic syndromes
  • Acute myeloid leukemia
🇯🇵
Approved in Japan as Vidaza for:
  • Myelodysplastic syndromes
  • Acute myeloid leukemia

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Genentech, Inc.

Industry Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
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