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Combination Study of IPH2201 (Monalizumab) With Ibrutinib in Relapsed, Refractory or Previously Untreated CLL
Phase 1, PHASE2 trial testing monalizumab in Chronic Lymphocytic Leukemia in 22 participants. Terminated before completion.
| Lead sponsor | Innate Pharma |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 9 November 2015 |
| Primary completion | 29 October 2018 |
| Estimated completion | 25 September 2019 |
| Sites | 1 location across United States |
Innate Pharma — full company profile →
18 and older, any sex, with Chronic Lymphocytic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of dose-limiting toxicities, measured during the phase 1, dose escalation, part of the study.
| Group | Value | 95% CI |
|---|---|---|
| Phase 1 Level 1 - 1 mg/kg | 0 | |
| Phase 1 Level 2 - 2 mg/kg | 1 | |
| Phase 1 Level 3 - 4 mg/kg | 2 |
The rate of complete response (CR) was evaluated using the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) grading scale and confirmed by a bone marrow biopsy. Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL), Complete Response (CR) is defined as lymphocytes \<4x109/l, absence of lymphadenopathy, hepatomegaly and splenomegaly at CT scan, no constitutional symptoms, no cytopenia, normocellular bone marrow. Partial Response (PR) is a reduction \> 50% in lymphocytes, lymphadenopathy, spleen or liver, no cytopenia. PD if appearance of any new lesion, or increase in
| Group | Value | 95% CI |
|---|---|---|
| Phase 1 Level 1 - 1 mg/kg | 1 | |
| Phase 1 Level 2 - 2 mg/kg | 1 | |
| Phase 1 Level 3 - 4 mg/kg | 0 | |
| Phase 2 RP2D - 2 mg/kg | 0 |
Measure of best overall response at any time during the study. cCR: confirmed complete response/remission; uCR: unconfirmed complete response / remission; PR: partial response/remission; SD: stable disease; PD: progressive disease. Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL), Complete Response (CR) is defined as lymphocytes \<4x109/l, absence of lymphadenopathy, hepatomegaly and splenomegaly at CT scan, no constitutional symptoms, no cytopenia, normocellular bone marrow. Partial Response (PR) is a reduction \> 50% in lymphocytes, lymphadenopathy, spleen or liver, no cyt
| Group | Value | 95% CI |
|---|---|---|
| Phase 1 Level 1 - 1 mg/kg | 1 | |
| Phase 1 Level 2 - 2 mg/kg | 1 | |
| Phase 1 Level 3 - 4 mg/kg | 0 | |
| Phase 2 RP2D - 2 mg/kg | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Phase 1 Level 1 - 1 mg/kg | 0 | |
| Phase 1 Level 2 - 2 mg/kg | 1 | |
| Phase 1 Level 3 - 4 mg/kg | 0 | |
| Phase 2 RP2D - 2 mg/kg | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Phase 1 Level 1 - 1 mg/kg | 2 | |
| Phase 1 Level 2 - 2 mg/kg | 3 | |
| Phase 1 Level 3 - 4 mg/kg | 2 | |
| Phase 2 RP2D - 2 mg/kg | 6 |
| Group | Value | 95% CI |
|---|---|---|
| Phase 1 Level 1 - 1 mg/kg | 0 | |
| Phase 1 Level 2 - 2 mg/kg | 1 | |
| Phase 1 Level 3 - 4 mg/kg | 1 | |
| Phase 2 RP2D - 2 mg/kg | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Phase 1 Level 1 - 1 mg/kg | 0 | |
| Phase 1 Level 2 - 2 mg/kg | 0 | |
| Phase 1 Level 3 - 4 mg/kg | 0 | |
| Phase 2 RP2D - 2 mg/kg | 0 |
The duration of remission (DOR) is defined as the time from the date of first evaluation of the remission (cCR, uCR or PR) to the first documentation of progressive disease, relapsed disease or death. In case an assessment of progressive / relapsed disease or death does not exist, the DOR was censored at the time of the last disease assessment date. The DOR was calculated only for the patients with a remission that was assessed at 52 weeks.
| Group | Value | 95% CI |
|---|---|---|
| Efficacy Population | NA | NA – NA |
The Progression Free Survival (PFS) is defined as the time from first dose administration until the occurrence of progressive disease, relapsed disease or death from any cause. Patients without an event at the time of the analyse were censored at his or her last disease assessment date. Patients with no post-Baseline assessment were censored at the day of the first dose administration.
| Group | Value | 95% CI |
|---|---|---|
| ITT / Safety Population | NA | NA – NA |
The overall survival (OS) is defined as the time from first dose administration until death from any cause. Alive patients were censored at the most recent date they were known to be alive. Subjects with no assessment post-Baseline were censored at the day of the first dose administration.
| Group | Value | 95% CI |
|---|---|---|
| All ITT / Safety Population | NA | NA – NA |
Time frame: The occurrences of Adverse Events were recorded from the time of signed informed consent until the end of the patient's participation to the trial (up to 24 months).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | 1 mg/kg | 2 mg/kg | 4 mg/kg |
|---|---|---|---|---|
| Supraventricular tachycardia | Cardiac disorders | — | — | — |
| Large intestinal haemorrhage | Gastrointestinal disorders | — | — | — |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | — | — | — |
| Pyrexia | General disorders | — | — | — |
| Sinusitis | Infections and infestations | — | — | — |
| Urinary tract infection enterococcal | Infections and infestations | — | — | — |
| Urosepsis | Infections and infestations | — | — | — |
| Amylase increased | Investigations | — | — | — |
| Platelet count decreased | Investigations | — | — | — |
| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Reaction | System | 1 mg/kg | 2 mg/kg | 4 mg/kg |
|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Contusion | Injury, poisoning and procedural complications | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Hypertension | Vascular disorders | — | — | — |
| Stomatitis | Gastrointestinal disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — | — |
| Oral pain | Gastrointestinal disorders | — | — | — |
| Chills | General disorders | — | — | — |
| Fatigue | General disorders | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Petechiae | Skin and subcutaneous tissue disorders | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Dry mouth | Gastrointestinal disorders | — | — | — |
| Herpes zoster | Infections and infestations | — | — | — |
| Fall | Injury, poisoning and procedural complications | — | — | — |
| Weight increased | Investigations | — | — | — |
| Arthritis | Musculoskeletal and connective tissue disorders | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Paraesthesia | Nervous system disorders | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — | — |
| Palpitations | Cardiac disorders | — | — | — |
| Ear pain | Ear and labyrinth disorders | — | — | — |
| Eye discharge | Eye disorders | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Localised oedema | General disorders | — | — | — |
Most-reported serious reactions: Supraventricular tachycardia, Large intestinal haemorrhage, Lower gastrointestinal haemorrhage, Pyrexia, Sinusitis, Urinary tract infection enterococcal, Urosepsis, Amylase increased.
Data from ClinicalTrials.gov NCT02557516 adverse events section.
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
8 peer-reviewed publications reference this trial (live from Europe PMC):
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