Clinical trial · Interventional
Combination Study of IPH2201 (Monalizumab) With Ibrutinib in Relapsed, Refractory or Previously Untreated CLL
Open Label 1b/2a Trial of a Combination of IPH2201 and Ibrutinib in Patients With Relapsed, Refractory or Previously Untreated Chronic Lymphocytic Leukemia
NCT02557516CI-TRIAL-00042388terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| monalizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Phase 1 Level 1 - 1 mg/kg
- description
- In phase 1, Monalizumab given at the first dose level of 1 mg/kg.
- interventionNames
- Drug: monalizumab
- type
- EXPERIMENTAL
- label
- Phase 1 Level 2 - 2 mg/kg
- description
- In phase 1, Monalizumab given at the second dose level of 2 mg/kg.
- interventionNames
- Drug: monalizumab
- type
- EXPERIMENTAL
- label
- Phase 1 Level 3 - 4 mg/kg
- description
- In phase 1, Monalizumab given at the third dose level of 4 mg/kg.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.