Combination Study of IPH2201 With Ibrutinib in Patients With Relapsed, Refractory or Previously Untreated Chronic Lymphocytic Leukemia
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
|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|
- Occurrence of Dose Limiting Toxicity in Phase Ib [ Time Frame: 56 weeks ]
- Rate of overall and complete or partial response [ Time Frame: 56 weeks ]
- Occurrence of adverse events and serious adverse events [ Time Frame: 2 years ]
|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)|
Experimental: Single arm
IPH2201 combined with ibrutinib
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02557516
|Contact: Renaud Buffet, MD||+33 4 30 30 30 email@example.com|
|United States, Ohio|
|The Ohio State University Wexner Medical Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Farrukh Awan, MD 614-688-7942 firstname.lastname@example.org|
|Principal Investigator:||Farrukh Awan, MD||Ohio State University|