76 Participants Needed

Azacitidine + Nivolumab/Midostaurin vs. Decitabine/Cytarabine for Acute Myeloid Leukemia

Recruiting at 571 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: National Cancer Institute (NCI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized phase II/III trial studies how well azacitidine with or without nivolumab or midostaurin, or decitabine and cytarabine alone work in treating older patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in chemotherapy, such as azacitidine, decitabine, and cytarabine, 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. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Midostaurin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine with or without nivolumab or midostaurin, or decitabine and cytarabine alone may kill more cancer cells.

Who Is on the Research Team?

LC

Laura C Michaelis

Principal Investigator

SWOG Cancer Research Network

Are You a Good Fit for This Trial?

This trial is for older adults with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Participants must not need concurrent cancer therapy (except hormonal), have acceptable liver function, be able to swallow pills, and consent to specimen banking. Women of childbearing age and sexually active men must use effective contraception. Those with central nervous system leukemia, prior specific treatments like midostaurin or DNA-methyltransferase inhibitors, or who are pregnant/nursing are excluded.

Inclusion Criteria

I can swallow pills without needing to crush or chew them.
I have had cancer before, but it doesn't need current treatment.
I have been diagnosed with AML or MDS-EB-2 and have not received treatment.
See 34 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive azacitidine with or without nivolumab or midostaurin, or decitabine and cytarabine alone. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

28 days per cycle, up to 2 cycles for induction

Maintenance

Patients deemed stable receive maintenance therapy with decitabine. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

28 days per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

5 years
Every 3 months for the 1st year, every 6 months for the 2nd and 3rd years, then annually

What Are the Treatments Tested in This Trial?

Interventions

  • Azacitidine
  • Cytarabine
  • Decitabine
  • Midostaurin
  • Nivolumab
Trial Overview The study compares the effectiveness of azacitidine alone versus in combination with nivolumab (an immunotherapy) or midostaurin (a growth blocker), against decitabine and cytarabine alone in treating certain blood cancers. It aims to determine which treatment stops cancer cells from growing by either killing them directly or boosting the immune response against them.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm D (decitabine, cytarabine)Experimental Treatment3 Interventions
Group II: Arm C (azacitidine, midostaurin)Experimental Treatment3 Interventions
Group III: Arm B (azacitidine, nivolumab)Experimental Treatment3 Interventions
Group IV: Arm A (azacitidine)Active Control2 Interventions

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

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Approved in European Union as Vidaza for:
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Approved in United States as Vidaza for:
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Approved in Canada as Vidaza for:
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Approved in Japan as Vidaza for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+
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