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Nucleoside Analog

Venetoclax + Azacitidine for Acute Myeloid Leukemia

Phase 2

Recruiting

Led By Betul Oran

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent

Serum creatinine =< 1.5 mg/dL or creatinine clearance greater or equal than 40 cc/min as defined by the Cockcroft-Gault equation

Must not have

Basal or squamous cell carcinoma of the skin

Uncontrolled GVHD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 days after last v+v dose

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial tests how well venetoclax and azacitidine work to treat acute myeloid leukemia after stem cell transplant. Venetoclax blocks a protein needed for cancer cell survival, and azacitidine works in different ways to stop the growth of cancer cells. Giving both drugs after stem cell transplant may help control high risk leukemia.

Who is the study for?

This trial is for patients with acute myeloid leukemia who are in remission after a stem cell transplant but have high-risk features like minimal residual disease. They should be within 42 to 100 days post-transplant, have good organ function, and no active graft-versus-host disease or other serious conditions.

What is being tested?

The effectiveness of venetoclax combined with azacitidine is being tested as a treatment to prevent the return of acute myeloid leukemia after stem cell transplantation. Venetoclax targets proteins that cancer cells need to survive, while azacitidine interferes with their growth.

What are the potential side effects?

Venetoclax and Azacitidine can cause side effects such as low blood counts leading to increased infection risk, bleeding or anemia; fatigue; nausea; constipation; diarrhea; and potential liver problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand the study's risks and benefits and can consent.

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My kidney function is within the required range.

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My AML is classified as high-risk based on specific genetic features.

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My leukemia did not fully respond after two different treatments.

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I have a specific type of leukemia and am in remission after a stem cell transplant.

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My leukemia is caused by previous cancer treatments.

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I am receiving a specific low-intensity treatment plan for my condition.

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My cancer is still detectable at a very low level after a stem cell transplant, even though it looks like I'm in remission.

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I am undergoing a strong chemotherapy or radiation therapy before a stem cell transplant.

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My white blood cell count is healthy without needing daily medication.

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My platelet count is at least 30 without recent transfusions.

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I have AML and am in remission after a stem cell transplant.

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I can take care of myself and am up and about more than half of my waking hours.

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My bone marrow test shows more than 5% blast cells before my stem cell transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a type of skin cancer.

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I have uncontrolled graft-versus-host disease.

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I do not have an active infection with HIV, HBV, or HCV.

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My prostate cancer was found by accident and is classified as T1a or T1b.

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I have a severe form of graft-versus-host disease.

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I am not on immune suppressants, except for calcineurin inhibitors, MMF, or sirolimus.

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I have not had serious heart problems like heart failure or a heart attack in the last 6 months.

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I have heart rhythm problems that are noticeable and not under control.

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My breast cancer is in the earliest stage.

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I have severe, ongoing graft-versus-host disease.

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I have early-stage cervical cancer.

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I am currently experiencing active bleeding.

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I do not have any ongoing serious infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 days after last v+v dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 days after last v+v dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 days after last v+v dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Relapse-free survival (RFS) time

Secondary study objectives

Graft-versus-host disease

Incidence of other inter-current adverse events during follow up

Incidence of severe (grade 3 or 4) infection

+2 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471

33%

Neutropenia

11%

SARS-CoV-2 test positive

11%

Sepsis

11%

Abdominal pain

11%

Pneumonia

11%

Rhinovirus infection

11%

COVID-19

11%

Gastroenteritis

11%

Pneumonia pseudomonal

11%

Electrocardiogram QT prolonged

11%

Anaemia

11%

Neutrophil count decreased

11%

Hypokalaemia

11%

Febrile neutropenia

11%

Supraventricular tachycardia

11%

Blood creatinine increased

11%

White blood cell count decreased

11%

Dermatitis

100%

80%

60%

40%

20%

Study treatment Arm

Bendamustine + Rituximab Crossover Substudy

Venetoclax + Rituximab Re-Treatment Substudy

Venetoclax + Rituximab Main Study

Bendamustine + Rituximab Main Study

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (azacitidine, venetoclax)Experimental Treatment2 Interventions

Patients receiving venetoclax and azacitidine for maintenance after allogeneic stem cell transplantation, receive azacitidine SC on days 1-5 and venetoclax PO QD on days 1-7. Patients receiving venetoclax and azacitidine for minimal residual disease after allogeneic stem cell transplant, receive azacitidine SC on days 1-5 and venetoclax PO QD on days 1-14. Treatment repeats every 4-8 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azacitidine

FDA approved

Venetoclax

FDA approved

0 / 27Eligibility criteria met