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Combination Study of IPH2201 With Ibrutinib in Patients With Relapsed, Refractory or Previously Untreated Chronic Lymphocytic Leukemia

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Innate Pharma
Sponsor:
Information provided by (Responsible Party):
Innate Pharma
ClinicalTrials.gov Identifier:
NCT02557516
First received: September 22, 2015
Last updated: November 24, 2016
Last verified: November 2016
  Purpose

Combination study of IPH2201 with Ibrutinib in relapsed or refractory Chronic Lymphocytic Leukemia (CLL) patients in 2 parts :

  • phase 1b : a 3+3 design to assess the Maximum Tolerated Dose (MTD)
  • phase 2a: to evaluate the anti-leukemic activity of the combination

Condition Intervention Phase
Chronic Lymphocytic Leukemia Drug: monalizumab Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label 1b/2a Trial of a Combination of IPH2201 and Ibrutinib in Patients With Relapsed, Refractory or Previously Untreated Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Innate Pharma:

Primary Outcome Measures:
  • Occurrence of Dose Limiting Toxicity in Phase Ib [ Time Frame: 56 weeks ]

Secondary Outcome Measures:
  • Rate of overall and complete or partial response [ Time Frame: 56 weeks ]
  • Occurrence of adverse events and serious adverse events [ Time Frame: 2 years ]

Estimated Enrollment: 45
Study Start Date: November 2015
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm
IPH2201 combined with ibrutinib
Drug: monalizumab

During phase 1b, patients receive IPH2201, IV, at the dose of 1, 2, 4 or 10 mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.

During phase 2a, patients receive IPH2201, IV, at the dose recommended upon completion of phase 1b portion, 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 IPH2201 (from week 0 to week 6) occur every 2 weeks. From the 5th administration IPH2201 is administered every 4 weeks.

Other Names:
  • Anti-NKG2A
  • IPH2201

Detailed Description:

This trial is designated to test the hypothesis that the combination of ibrutinib and IPH2201 will result in a substantial complete response (CR) rate, especially CR without minimal residual disease (MRD), as this has been shown to be associated with long-term clinical benefit.

Up to 45 patients are planned to be enrolled. During the phase 1b portion of the study, a 3+3 design wil be employed. Four doses are planned to be assessed if the Maximum Tolerated Dose (MTD) is not previously reached: 1, 2, 4 and 10 mg/kg.

During the phase 2a portion, patients will receive IPH2201 in combination with ibrutinib; IPH2201 will be given at the dose recommended upon completion of the phase Ib portion.

The primary objective of the phase 1b is to assess the safety of IPH2201 given intravenously as a single agent and in combination with ibrutinib in patients with relapsed or refractory Chronic Lymphocytic Leukemia previously treated with at least one line of treatment.

The primary objective of the phase 2a is to evaluate the anti-leukemic activity of the combination of IPH2201 and ibrutinib in patients with relapsed or refractory Chronic Lymphocytic Leukemia previously treated with at least one line of treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)
  • Relapsed, refractory or previously untreated CLL
  • CLL requiring treatment; patients must be eligible for ibrutinib therapy
  • Age > = 18 years
  • Eastern Cooperative Oncology Group performance status of 0-2
  • Life expectancy > = 3 months
  • Adequate liver and renal function
  • Negative serum pregnancy test within 72 hours before starting study treatment in women with childbearing potential. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study participation
  • Ability to understand a written informed and consent document
  • Signed informed consent prior to any protocol-specific procedures

Exclusion Criteria:

  • Patients who have previously received ibrutinib or another inhibitor of Bruton's tyrosine kinase (BTK)
  • History of allergic reactions attributed to compounds or similar chemical or biological composition to ibrutinib
  • Central nervous system involvement of the CLL
  • Abnormal hematological function which is not due to bone marrow failure related to the CLL
  • Patients requiring a treatment by oral vitamin K antagonists
  • Serious uncontrolled medical disorder
  • Medical condition or organ system dysfunction which, in the investigator opinion, could interfere with absorption or metabolism of ibrutinib
  • Moderate or severe hepatic impairment
  • Active auto-immune disease
  • Abnormal cardiac status
  • Pregnant women are excluded from study
  • Current active infectious disease
  • History of another malignancy within 3 years
  • History of allogeneic stem cell or solid organ transplantation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02557516

Contacts
Contact: Renaud Buffet, MD +33 4 30 30 30 30 renaud.buffet@innate-pharma.fr

Locations
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Farrukh Awan, MD    614-688-7942    farrukh.awan@osumc.edu   
Sponsors and Collaborators
Innate Pharma
Investigators
Principal Investigator: Farrukh Awan, MD Ohio State University
  More Information

Responsible Party: Innate Pharma
ClinicalTrials.gov Identifier: NCT02557516     History of Changes
Other Study ID Numbers: IPH2201-202
Study First Received: September 22, 2015
Last Updated: November 24, 2016

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell

ClinicalTrials.gov processed this record on July 28, 2017