A Phase 2, Multicenter, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
MedImmune LLC
Study ID
NCT01466153
Phase
PHASE2
Status
Completed

Conditions

  • Chronic Lymphocytic Leukemia (CLL)

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab was administered by IV infusion as a dose of 375 mg/m\^2 on Day 2 of Cycle 1 and then at 500 mg/m\^2 on Day 1 of up to 5 subsequent 28-day cycles
  • Bendamustine — DRUG
    Bendamustine was administered by IV infusion as a dose of 70 mg/m\^2 on Day 1 and Day 2 of each 5 subsequent 28-day cycle.
  • MEDI-551 — DRUG
    MEDI-551 was administered at 2 mg/kg or 4 mg/kg by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycles.

Study Details

The overall purpose of the study was to determine if MEDI-551, when used in combination with salvage chemotherapy (bendamustine) in participants with relapsed or refractory CLL who are not eligible for Autologous Stem Cell Transplant (ASCT), had superior efficacy compared to rituximab in the same population.

Key Dates

Start date
Feb 7, 2012
Status verified
Apr 2017
Primary completion
Jan 8, 2016
Completion
Jan 8, 2016

Study Design

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

Arms

  • Active Comparator: Rituximab + Bendamustine
    Rituximab was administered by IV infusion as 375 mg/m\^2 on Day 2 of Cycle 1 and then 500 mg/m\^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
  • Experimental: MEDI-551 2 mg/kg + Bendamustine
    MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
  • Experimental: MEDI-551 4 mg/kg + Bendamustine
    MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.

Primary Outcome Measure

Objective Response Rate [ Time Frame: From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months) ]

Locations (14)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama--
Research SiteBurbankCalifornia--
Research SiteLa JollaCalifornia--
Research SitePalm SpringsCalifornia--
Research SiteSkokieIllinois--
Research SiteShreveportLouisiana--
Research SiteBaltimoreMaryland--
Research SiteDetroitMichigan--
Research SiteFargoNorth Dakota--
Research SiteDaytonOhio--
Research SiteNewarkOhio--
Research SiteWatertownSouth Dakota--
Research SiteLubbockTexas--
Research SiteMorgantownWest Virginia--

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By research site
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