Open Label 1b/2a Trial of a Combination of IPH2201 and Ibrutinib in Patients With Relapsed, Refractory or Previously Untreated Chronic Lymphocytic Leukemia

Status: Terminated

Location: See location...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Phase 1/Phase 2

SUMMARY

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

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• 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

Locations

United States

Ohio

The Ohio State University Wexner Medical Center

Columbus

Time Frame

Start Date: 2015-11-09

Completion Date: 2019-09-25

Participants

Target number of participants: 22

Treatments

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.

Authors

Farrukh Awan

Related Therapeutic Areas

Chronic Lymphocytic Leukemia (CLL)

Leukemia

Small Lymphocytic Lymphoma (SLL)

Chronic B-Cell Leukemia (CBCL)

Open Label 1b/2a Trial of a Combination of IPH2201 and Ibrutinib in Patients With Relapsed, Refractory or Previously Untreated Chronic Lymphocytic Leukemia

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