An Efficacy and Safety Study of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Adults With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly Patients With Acute Myeloid Leukemia (AML)

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Celgene
Study ID
NCT02775903
Phase
PHASE2
Status
Completed

Conditions

  • Leukemia, Myeloid, Acute
  • Myelodysplastic Syndromes

Eligibility Criteria

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

Interventions

  • Azacitidine — DRUG
    Administered by subcutaneous injection on Days 1 to 7 of each 4-week treatment cycle.
  • Durvalumab — BIOLOGICAL
    Administered by intravenous infusion on Day 1 of every 4-week treatment cycle.

Study Details

The primary objective of this study is to evaluate the efficacy of subcutaneous azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in adults with previously untreated, higher risk MDS who are not eligible for HSCT or in adults ≥ 65 years old with previously untreated AML who are not eligible for HSCT, with intermediate or poor cytogenetic risk.

Key Dates

Start date
Jun 3, 2016
Status verified
Feb 2023
Primary completion
Dec 31, 2018
Completion
Dec 27, 2021

Study Design

Enrollment
213 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Azacitidine + Durvalumab
    Participants received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.
  • Active Comparator: Azacitidine Alone
    Participants received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.

Primary Outcome Measure

MDS Cohort: Overall Response Rate [ Time Frame: Response was assessed following every 3 treatment cycles until treatment discontinuation; median duration of treatment was 239 days (AZA) and 215 days (DUR) in the AZA + DUR group and 210 days in the AZA alone group. ]

Locations (12)

FacilityCityStateZIPSite coordinators
Yale Cancer CenterNew HavenConnecticut06520-
Georgetown University HospitalWashington D.C.District of Columbia20007-
University of FloridaGainesvilleFlorida32610-
Moffitt Cancer CenterTampaFlorida33612-
University of ChicagoChicagoIllinois60637-
Hackensack University Medical CenterHackensackNew Jersey07601-
Roswell Park Cancer InstituteBuffaloNew York14263-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Duke University Medical CenterDurhamNorth Carolina27705-
Avera Cancer InstituteSioux FallsSouth Dakota57105-
Vanderbilt University Medical CenterNashvilleTennessee37203-
University of Texas- MD AndersonHoustonTexas77230-

Find similar trials in New Haven, CT

By research site
Yale Cancer Center· New Haven, CTGeorgetown University Hospital· Washington D.C., DCUniversity of Florida· Gainesville, FLMoffitt Cancer Center· Tampa, FLUniversity of Chicago· Chicago, ILHackensack University Medical Center· Hackensack, NJ

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