What side effects are associated with this type of intervention?

Common treatments for Acute Myeloid Leukemia (AML) include chemotherapy agents like cytarabine and daunorubicin, hypomethylating agents such as azacitidine, and targeted therapies like venetoclax. These treatments can cause a range of side effects, including myelosuppression (leading to anemia, neutropenia, and thrombocytopenia), gastrointestinal symptoms (nausea, vomiting, diarrhea), fatigue, and increased risk of infections. Immune cell therapies, such as the use of NK cells, may also lead to infusion-related reactions, cytokine release syndrome, and potential graft-versus-host disease (GVHD) in the context of allogeneic cell transplants.

What prior FDA approvals exist?

The FDA has approved several treatments for Acute Myeloid Leukemia (AML), including hypomethylating agents like Azacitidine and Decitabine, and the BCL-2 inhibitor Venetoclax. These drugs are often used in combination to enhance their efficacy. While the use of Natural Killer (NK) cells as an immune cell therapy is still under investigation, other immune-based therapies, such as immune checkpoint inhibitors, are being explored for their potential in treating AML. However, specific FDA approvals for NK cell therapies in AML are not yet established.

What other types of research exist?

Promising novel alternatives to NK cell therapy for AML patients include T-cell-based immunotherapies, such as those targeting TIM3 and STING pathways, and combination therapies like low-dose cytarabine with venetoclax or glasdegib. These approaches have shown potential in improving outcomes for AML patients.

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Anti-metabolites

Azacitidine + Venetoclax + NK Cells for Acute Myeloid Leukemia

Phase 1

Recruiting

Led By Abhishek Maiti, MD

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if adding special immune cells from a healthy person to two existing cancer drugs can better control a type of blood cancer. The immune cells help fight cancer and infections. The two drugs work by killing cancer cells. These drugs have been used together to treat this type of blood cancer, showing improved response rates and survival compared to using one of the drugs alone.

Who is the study for?

This trial is for adults diagnosed with Acute Myeloid Leukemia (AML) or related conditions, who have relapsed or don't respond to standard treatments. It's also open to older patients unfit for intensive chemotherapy. Participants must not have certain infections, severe heart issues, other active cancers, or be pregnant. They should agree to use contraception and understand the study.

What is being tested?

The trial tests if adding Natural Killer (NK) cells from healthy donors to Azacitidine and Venetoclax treatment can better control AML. NK cells are part of the immune system that helps fight cancer.

What are the potential side effects?

Potential side effects may include reactions at the infusion site, fatigue, nausea, liver problems like jaundice, kidney issues such as reduced urine output, blood disorders like anemia or clotting problems, and increased risk of infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment3 Interventions

Dose Expansion to evaluate the combination of azacitidine, venetoclax and allogeneic NK cells in older/unfit participants with AML ineligible for intensive chemotherapy or allogeneic stem-cell transplantation (allo SCT).

Group II: Dose EscalationExperimental Treatment3 Interventions

Dose Escalation to evaluate the combination of azacitidine, venetoclax and allogeneic NK cells in older/unfit participants with AML ineligible for intensive chemotherapy or allogeneic stem-cell transplantation (allo SCT).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~2200

Azacitidine

2012

Completed Phase 3

~1440

NK Cells

2020

Completed Phase 2

~40

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acute Myeloid Leukemia (AML) include chemotherapy, targeted therapies, and immune cell therapies. Chemotherapy agents like cytarabine and daunorubicin work by damaging the DNA of rapidly dividing cells, leading to cell death. Targeted therapies, such as gilteritinib, inhibit specific mutations like FLT3, which are involved in the proliferation of leukemic cells. Immune cell therapies, including the use of natural killer (NK) cells, enhance the body's immune response to target and destroy cancer cells. These treatments are crucial for AML patients as they aim to achieve complete remission, reduce disease burden, and improve survival rates.

Progress in the problem of relapsed or refractory acute myeloid leukemia.DOCK4 deletion at 7q31.1 in a de novo acute myeloid leukemia with a normal karyotype.