Ipilimumab in Treating Patients With Relapsed or Refractory High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01757639
Phase
PHASE1
Status
Completed

Conditions

  • Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
  • Chronic Myelomonocytic Leukemia
  • Myelodysplastic Syndrome
  • Previously Treated Myelodysplastic Syndrome
  • Recurrent Adult Acute Myeloid Leukemia
  • Secondary Myelodysplastic Syndrome

Eligibility Criteria

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

Interventions

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

Study Details

This phase I trial studies the side effects and best dose of ipilimumab and how well it works in treating patients with high-risk myelodysplastic syndrome or acute myeloid leukemia that has come back or no longer responds to treatment. Monoclonal antibodies, such as ipilimumab, may interfere with the ability of cancer cells to grow and spread.

Key Dates

Start date
Dec 14, 2012
Status verified
Nov 2017
Primary completion
Dec 31, 2016

Study Design

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

Arms

  • Experimental: Treatment (ipilimumab)
    INDUCTION: Patients receive ipilimumab IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Beginning 12 weeks after last dose of induction ipilimumab, patients receive ipilimumab IV on day 1. Treatment repeats every 12 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of DLT of ipilimumab by grading and tabulation using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: 42 days ]

Locations (9)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06520-
Yale-New Haven Hospital North Haven Medical CenterNorth HavenConnecticut06473-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Washington University School of MedicineSt LouisMissouri63110-
Columbia University/Herbert Irving Cancer CenterNew YorkNew York10032-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Duke University Medical CenterDurhamNorth Carolina27710-
Baylor University Medical CenterDallasTexas75246-
Texas Oncology at Baylor Irving Cancer CenterIrvingTexas75061-

Find similar trials in New Haven, CT

By research site
Yale University· New Haven, CTYale-New Haven Hospital North Haven Medical Center· North Haven, CTJohns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MDWashington University School of Medicine· St Louis, MOColumbia University/Herbert Irving Cancer Center· New York, NYUNC Lineberger Comprehensive Cancer Center· Chapel Hill, NC

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