Venetoclax + Decitabine for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

Abhishek Maiti | MD Anderson Cancer Center

Overseen byMarina Konopleva

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase II trial studies how well venetoclax and decitabine work in treating participants with acute myeloid leukemia that has come back or does not respond to treatment, or with high-risk myelodysplastic syndrome that has come back. Drugs used in chemotherapy, such as venetoclax and decitabine, 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.

Eligibility Criteria

This trial is for adults under 60 with newly diagnosed AML or high-risk MDS, not responding to treatment or relapsed. Participants must have adequate liver and kidney function, not be pregnant or breastfeeding, agree to use contraception if of childbearing potential, and cannot have certain blood cancers (like acute promyelocytic leukemia) or uncontrolled medical conditions.

Inclusion Criteria

I am 60 or younger with a specific type of aggressive AML.

My kidney function is normal, with creatinine levels below 2.

Alanine aminotransferase (ALT) < 3 x ULN unless considered due to leukemic involvement

+11 more

Exclusion Criteria

My leukemia is of a specific type known as APL (M3-AML).

I have leukemia in my brain that is causing symptoms or is not well-controlled.

I do not have any severe ongoing health issues like uncontrolled infections, high blood pressure, heart failure, or irregular heartbeats.

+4 more

Participant Groups

The study tests how well venetoclax combined with decitabine works in treating relapsed/refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). It's a phase II trial focusing on the effectiveness of these chemotherapy drugs in stopping cancer cell growth.

1Treatment groups

Experimental Treatment

Group I: Treatment (decitabine, venetoclax)Experimental Treatment3 Interventions

Participants receive decitabine IV over 1 hour on days 1-10 and may also receive decitabine on days 1-5 after achieving complete remission/complete remission with incomplete count recovery during consolidation/maintenance. Participants also receive venetoclax PO daily on days 1-28 of cycle 1 and on days 1-21 of subsequent cycles. Treatment repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

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

🇪🇺 Approved in European Union as Dacogen for: