Chronic Lymphocytic LeukemiaPhase 1/2NCT02557516

Combination Study of IPH2201 (Monalizumab) With Ibrutinib in Relapsed, Refractory or Previously Untreated CLL

A Phase 1/2 study testing monalizumab in people with Chronic Lymphocytic Leukemia, run by Innate Pharma at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Lymphocytic Leukemia
What is being tested?: monalizumab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: 9 Nov 2015to 25 Sep 2019
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

Show all 14Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210

Other trials in United States

About this study

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

Read the detailed description

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.

Conditions: Chronic Lymphocytic Leukemia
Being tested: monalizumab
Medical subject headings: Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

monalizumabDrug
Also called Anti-NKG2A, IPH2201
During phase 1, patients received monalizumab, IV, at the dose of 1, 2 or 4mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.
During phase 2, patients received monalizumab, IV, at the dose recommended upon completion of phase 1, 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 monalizumab (from week 0 to week 6) occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks.

Study groups in NCT02557516
Study group	Role	What they receive
Phase 1 Level 1 - 1 mg/kg	Experimental	In phase 1, Monalizumab given at the first dose level of 1 mg/kg. Receives: Drug: monalizumab
Phase 1 Level 2 - 2 mg/kg	Experimental	In phase 1, Monalizumab given at the second dose level of 2 mg/kg. Receives: Drug: monalizumab
Phase 1 Level 3 - 4 mg/kg	Experimental	In phase 1, Monalizumab given at the third dose level of 4 mg/kg. Receives: Drug: monalizumab
Phase 2 RP2D - 2 mg/kg	Experimental	In phase 2, Monalizumab given at the Recommended Phase 2 Dose (RP2D) of 2 mg/kg, selected by a safety committee. Receives: Drug: monalizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Dose Limiting Toxicities
Number of dose-limiting toxicities, measured during the phase 1, dose escalation, part of the study.
Measured: 8 weeks
Rate of Complete Response (CR)
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 lymphocytes > 50%, or occurrence of cytopenia attributable to CLL.
Measured: CR assessed 52 weeks after the beginning of combination treatment

Secondary outcomes (4)

Best Overall Response / Remission Rates
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 cytopenia. PD if appearance of any new lesion, or increase in lymphocytes > 50%, or occurrence of cytopenia attributable to CLL.
In order to have a confirmed CR (cCR), the CR must be confirmed by a scan and a bone marrow assessment assessed at least 2 months after the first occurrence of CR. Otherwise it would be an unconfirmed CR (uCR).
Measured: From beginning of study drug treatment to the end of study (up to 24 months)
Duration of Remission
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.
Measured: Up to 24 months
Progression Free Survival
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.
Measured: Up to 24 months
Overall Survival
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.
Measured: Up to 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Nov 201525 Sep 2019

First posted23 Sep 2015 (estimated)
Study start9 Nov 2015
Primary completion29 Oct 2018
Study completion25 Sep 2019

Why it stopped: Sponsor decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02557516
Sponsor's protocol ID: IPH2201-202
Status last verified: Dec 2019
First submitted: 22 Sep 2015
Last updated: 17 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02557516
Acronym / sponsor ID: IPH2201-202
Conditions: Chronic Lymphocytic Leukemia
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision
Enrolment: 22 participants (actual)
Lead sponsor: Innate PharmaIndustry (pharma, biotech, devices)
Study start: 9 Nov 2015 (actual)
Primary completion: 29 Oct 2018 (actual)
Study completion: 25 Sep 2019 (actual)
First posted: 23 Sep 2015 (estimated)
Results: Posted 17 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Phase 1 Level 1 - 1 mg/kg	Experimental	Drug: monalizumabIn phase 1, Monalizumab given at the first dose level of 1 mg/kg.
Phase 1 Level 2 - 2 mg/kg	Experimental	Drug: monalizumabIn phase 1, Monalizumab given at the second dose level of 2 mg/kg.
Phase 1 Level 3 - 4 mg/kg	Experimental	Drug: monalizumabIn phase 1, Monalizumab given at the third dose level of 4 mg/kg.
Phase 2 RP2D - 2 mg/kg	Experimental	Drug: monalizumabIn phase 2, Monalizumab given at the Recommended Phase 2 Dose (RP2D) of 2 mg/kg, selected by a safety committee.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
monalizumabAlso: Anti-NKG2A, IPH2201During phase 1, patients received monalizumab, IV, at the dose of 1, 2 or 4mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks. During phase 2, patients received monalizumab, IV, at the dose recommended upon completion of phase 1, 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 monalizumab (from week 0 to week 6) occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks.	Drug	Phase 1 Level 1 - 1 mg/kg, Phase 1 Level 2 - 2 mg/kg, Phase 1 Level 3 - 4 mg/kg, Phase 2 RP2D - 2 mg/kg

Primary outcome

Number of Dose Limiting Toxicities
Time frame: 8 weeks
Number of dose-limiting toxicities, measured during the phase 1, dose escalation, part of the study.
Rate of Complete Response (CR)
Time frame: CR assessed 52 weeks after the beginning of combination treatment
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 lymphocytes > 50%, or occurrence of cytopenia attributable to CLL.

4 secondary outcomes

Best Overall Response / Remission Rates
Time frame: From beginning of study drug treatment to the end of study (up to 24 months)
Duration of Remission
Time frame: Up to 24 months
Progression Free Survival
Time frame: Up to 24 months
Overall Survival
Time frame: Up to 24 months.

Results and safety

Results posted to the registry on 17 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1 Level 1 - 1 mg/kg	3	2
Phase 1 Level 2 - 2 mg/kg	6	1
Phase 1 Level 3 - 4 mg/kg	4	0
Phase 2 RP2D - 2 mg/kg	9	0

Primary outcome: Number of Dose Limiting Toxicities

Time frame: 8 weeks. Number. Unit: Dose Limiting Toxicy

Measure	Phase 1 Level 1 - 1 mg/kg n = 3	Phase 1 Level 2 - 2 mg/kg n = 6	Phase 1 Level 3 - 4 mg/kg n = 4
Value	0	1	2

Population analysed: During phase 1 part of the study (dose escalation) the total number of patients evaluated for safety parameters is 13; 3 patients received at least one dose of monalizumab 1 mg/kg, 6 patients received 2 mg/kg , and 4 patients received 4 mg/kg.

Primary outcome: Rate of Complete Response (CR)

Time frame: CR assessed 52 weeks after the beginning of combination treatment. Count of participants. Unit: Participants

Measure	Phase 1 Level 1 - 1 mg/kg n = 3	Phase 1 Level 2 - 2 mg/kg n = 6	Phase 1 Level 3 - 4 mg/kg n = 3	Phase 2 RP2D - 2 mg/kg n = 9
Value	1	1	0	0

Population analysed: Efficacy population: 21 patients who received at least one dose of monalizumab. According to the protocol, patients who discontinued treatment due to disease progression before the end of 8 weeks were replaced. Of note,1 patient (grade 3 hemolytic anemia due to disease progression at W4) was replaced and was then excluded from efficacy population.

4 secondary outcomes are reported in the full results.

Adverse events

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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1 mg/kg	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3
2 mg/kg	5 of 15 (33.3%)	15 of 15 (100%)	0 of 15
4 mg/kg	3 of 4 (75%)	4 of 4 (100%)	0 of 4

Limitations and caveats (from the sponsor): Due to early termination some of the secondary endpoints could not be evaluated.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kerry A Rogers, MD principal investigator

Ohio State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing monalizumab in people with Chronic Lymphocytic Leukemia, run by Innate Pharma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Dose Limiting Toxicities (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02557516.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.