Combination Study of IPH2201 (Monalizumab) With Ibrutinib in Relapsed, Refractory or Previously Untreated CLL

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Innate Pharma
Study ID
NCT02557516
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • monalizumab — DRUG
    During phase 1, patients received monalizumab, IV, at the dose of 1, 2 or 4mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks. During phase 2, patients received monalizumab, IV, at the dose recommended upon completion of phase 1, combined with ibrutinib 420 mg orally, once daily, from the first cycle, during 52 weeks. In both parts of the trial, the first 4 administrations of monalizumab (from week 0 to week 6) occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks.

Study Details

Combination study of monalizumab (IPH2201) with Ibrutinib in relapsed, refractory or previously untreated Chronic Lymphocytic Leukemia (CLL) patients in 2 parts : * phase 1 : a 3+3 design to assess the Maximum Tolerated Dose (MTD) * phase 2: to evaluate the anti-leukemic activity of the combination

Key Dates

Start date
Nov 9, 2015
Status verified
Dec 2019
Primary completion
Oct 29, 2018
Completion
Sep 25, 2019

Study Design

Enrollment
22 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Level 1 - 1 mg/kg
    In phase 1, Monalizumab given at the first dose level of 1 mg/kg.
  • Experimental: Phase 1 Level 2 - 2 mg/kg
    In phase 1, Monalizumab given at the second dose level of 2 mg/kg.
  • Experimental: Phase 1 Level 3 - 4 mg/kg
    In phase 1, Monalizumab given at the third dose level of 4 mg/kg.
  • Experimental: Phase 2 RP2D - 2 mg/kg
    In phase 2, Monalizumab given at the Recommended Phase 2 Dose (RP2D) of 2 mg/kg, selected by a safety committee.

Primary Outcome Measure

Number of Dose Limiting Toxicities [ Time Frame: 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Wexner Medical CenterColumbusOhio43210-

Find similar trials in Columbus, OH

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
The Ohio State University Wexner Medical Center· Columbus, OH

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