Nivolumab in AML in Remission at High Risk for Relapse

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02532231
Phase
PHASE2
Status
Completed

Conditions

  • Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
  • Adult Acute Myeloid Leukemia in Remission
  • Blasts Under 10 Percent of Bone Marrow Nucleated Cells
  • Therapy-Related Myeloid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

This phase II trial studies how well nivolumab works in treating patients with acute myeloid leukemia that has decreased or disappeared but may still be in the body (remission), and is at high risk for returning (relapse). 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.

Key Dates

Start date
Oct 19, 2015
Status verified
Oct 2024
Primary completion
Aug 8, 2023
Completion
Aug 8, 2023

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (nivolumab)
    Patients receive nivolumab IV over 1 hour on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After cycle 6, patients may receive nivolumab on day 1 only. After cycle 12, patients may receive nivolumab on day 1 of every 3 cycles. Patients experiencing disease progression may go back to receiving treatment on days 1 and 15 of each cycle.

Primary Outcome Measure

Recurrence-free Survival Rate [ Time Frame: Up to 7 years 9 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
M D Anderson Cancer Center· Houston, TX

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