Chronic Lymphocytic Leukemia Clinical Trial
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
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
This trial was 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 were planned to be enrolled. During the phase 1 part a 3+3 dose escalation
design was employed. Four doses were planned to be assessed if the Maximum Tolerated Dose
(MTD) was not previously reached: 1, 2, 4 and 10 mg/kg.
During phase 2 part, patients received monalizumab in combination with ibrutinib; monalizumab
was given at the dose recommended upon completion of the phase I portion.
The primary objective of the phase 1 was to assess the safety of monalizumab given
intravenously as a single agent and in combination with ibrutinib in patients with relapsed,
refractory or previously untreated Chronic Lymphocytic Leukemia.
The primary objective of the phase 2 was to evaluate the anti-leukemic activity of the
combination of monalizumab and ibrutinib in patients with relapsed, refractory or previously
untreated Chronic Lymphocytic Leukemia.
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