Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndrome
• Myelodysplastic Syndrome/Acute Myeloid Leukemia

Eligibility Criteria

Sex

ALL

Age

60 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Azacitidine — DRUG
  Given SC or IV
• Cytarabine — DRUG
  Given IV
• Decitabine — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Midostaurin — DRUG
  Given PO
• Nivolumab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

Feb 2, 2018

Status verified

Dec 2024

Primary completion

Aug 1, 2023

Completion

Jun 26, 2024

Study Design

Enrollment

76 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A (azacitidine)
  Patients receive azacitidine SC or IV daily on days 1-7 or on an interrupted schedule which ensures that all 7 days of therapy are received within a 12 day period. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm B (azacitidine, nivolumab)
  Patients receive azacitidine as in Arm A and nivolumab IV over 30-60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm C (azacitidine, midostaurin)
  Patients receive azacitidine as in Arm A and midostaurin orally (PO) twice daily (BID) on days 8-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm D (decitabine, cytarabine)
  INDUCTION: Patients receive decitabine IV over 2 hours on days 1-5 and cytarabine IV continuously on days 6-11. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients deemed stable at the discretion of the treating physician receive decitabine as in Induction. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall Survival (OS) (Phase II) [ Time Frame: Day of registration on study until death from any cause, assessed for up to 5 years ]

Locations (506)

Find similar trials in Anchorage, AK

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