Trial Outcomes & Findings for Study of Idelalisib in Combination With BI 836826 in Participants With Chronic Lymphocytic Leukemia (NCT NCT02538614)

Last Updated: 2020-11-25

Results Overview

DLTs refer to toxicities experienced during the final 6 weeks of 7-week study treatment that have been judged to be clinically significant and related to study treatment. Events occurring during the initial 7-day idelalisib monotherapy run-in period and resolving by Day 8 were not included.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

2 participants

Primary outcome timeframe

Up to 7 weeks

Results posted on

2020-11-25

Participant Flow

Participants were enrolled at study sites in the United States. The first participant was screened on 29 December 2015. The last study visit occurred on 05 July 2017.

5 participants were screened. Due to the early study termination, phase 2 was not initiated. Enrollment to this study was closed during Phase 1b. The 2 enrolled participants were allowed to remain on the study.

Participant milestones

Participant milestones
Measure	Phase 1b: Idelalisib + BI 836826 Idelalisib 50 mg tablet was administered orally twice daily each day until the end of treatment. BI 836826 was administered intravenously as a rate-controlled infusion. An initial dose of 10 mg was administered on Day 8. Doses of 50 mg were administered on Day 9 and Day 15. The full assigned dose of 100 mg was administered on Day 22, every 2 weeks thereafter through Week 18, and every 4 weeks thereafter through Week 46.
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1b: Idelalisib + BI 836826 Idelalisib 50 mg tablet was administered orally twice daily each day until the end of treatment. BI 836826 was administered intravenously as a rate-controlled infusion. An initial dose of 10 mg was administered on Day 8. Doses of 50 mg were administered on Day 9 and Day 15. The full assigned dose of 100 mg was administered on Day 22, every 2 weeks thereafter through Week 18, and every 4 weeks thereafter through Week 46.
Overall Study Progressive Disease	2

Baseline Characteristics

Study of Idelalisib in Combination With BI 836826 in Participants With Chronic Lymphocytic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1b: Idelalisib + BI 836826 n=2 Participants Idelalisib 50 mg tablet was administered orally twice daily each day until the end of treatment. BI 836826 was administered intravenously as a rate-controlled infusion. An initial dose of 10 mg was administered on Day 8. Doses of 50 mg were administered on Day 9 and Day 15. The full assigned dose of 100 mg was administered on Day 22, every 2 weeks thereafter through Week 18, and every 4 weeks thereafter through Week 46.
Age, Customized >= 65 Years	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race/Ethnicity, Customized Race-Data not reported	NA Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity-Data not Reported	NA Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 7 weeks

Population: Due to early study termination this outcome measure was not assessed.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 18 months

Population: Due to early study termination this outcome measure was not assessed.

CRR was defined as the percentage of participants who achieve a complete response (CR). CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Week 50

Population: Due to early study termination this outcome measure was not assessed.

MRD defined as the percentage of participants with MRD \< 10\^-4, assessed by flow cytometry in bone marrow, achieved by Week 50.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 18 months

Population: Due to early study termination this outcome measure was not assessed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 18 months

Population: The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.

An SAE is defined as an event that, at any dose, results in the following: death, life-threatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.

Outcome measures

Outcome measures
Measure	Phase 1b: Idelalisib + BI 836826 n=2 Participants Idelalisib 50 mg tablet was administered orally twice daily each day until the end of treatment. BI 836826 was administered intravenously as a rate-controlled infusion. An initial dose of 10 mg was administered on Day 8. Doses of 50 mg were administered on Day 9 and Day 15. The full assigned dose of 100 mg was administered on Day 22, every 2 weeks thereafter through Week 18, and every 4 weeks thereafter through Week 46.
For Phase 1b and Phase 2: Number of Participants Experiencing Any Serious Adverse Events (SAE)	2 Participants

SECONDARY outcome

Timeframe: Up to 18 months

Population: The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.

An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The severity of AEs was graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.

Outcome measures

Outcome measures
Measure	Phase 1b: Idelalisib + BI 836826 n=2 Participants Idelalisib 50 mg tablet was administered orally twice daily each day until the end of treatment. BI 836826 was administered intravenously as a rate-controlled infusion. An initial dose of 10 mg was administered on Day 8. Doses of 50 mg were administered on Day 9 and Day 15. The full assigned dose of 100 mg was administered on Day 22, every 2 weeks thereafter through Week 18, and every 4 weeks thereafter through Week 46.
For Phase 1b and Phase 2: Number of Participants Who Permanently Discontinued Study Treatment Due to an Adverse Event	0 Participants

SECONDARY outcome

Timeframe: Up to 18 months

Population: Due to early study termination this outcome measure was not assessed.

ORR was defined as the percentage of participants achieving a complete response (CR) or partial response (PR). CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 18 months

Population: Due to early study termination this outcome measure was not assessed.

DCR was defined as the interval from the first documentation of CR to the earlier of the first documentation of definitive disease progression or death from any cause. CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 18 months

Population: Due to early study termination this outcome measure was not assessed.

DOR was defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause. CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 18 months

Population: Due to early study termination this outcome measure was not assessed.

PFS was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was defined as evidence of any new disease, worsening of index lesions, spleen or liver, or non-index disease, decrease in platelet count or hemoglobin that is attributable to chronic lymphocytic leukemia (CLL) or more than 4 weeks after the discontinuation of idelalisib: an increase in the number of blood lymphocytes by 50% or more.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 18 months

Population: Due to early study termination this outcome measure was not assessed.

OS was defined as the interval from the randomization to the date of death from any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 18 months

Population: Due to early study termination this outcome measure was not assessed.

MRD negativity rate in blood was defined as the percentage of participants with MRD \< 10\^-4, assessed by flow cytometry in blood, at any time on study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 18 months

Population: Due to early study termination this outcome measure was not assessed.

MRD negativity rate in bone marrow was defined as the percentage of participants with MRD \< 10\^-4, assessed by flow cytometry in bone marrow, at any time on study.

Outcome measures

Outcome data not reported

Adverse Events

Phase 1b: Idelalisib + BI 836826

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1b: Idelalisib + BI 836826 n=2 participants at risk Idelalisib 50 mg tablet was administered orally twice daily each day until the end of treatment. BI 836826 was administered intravenously as a rate-controlled infusion. An initial dose of 10 mg was administered on Day 8. Doses of 50 mg were administered on Day 9 and Day 15. The full assigned dose of 100 mg was administered on Day 22, every 2 weeks thereafter through Week 18, and every 4 weeks thereafter through Week 46.
Infections and infestations Upper respiratory tract infection	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Investigations Aspartate aminotransferase increased	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.

Other adverse events

Other adverse events
Measure	Phase 1b: Idelalisib + BI 836826 n=2 participants at risk Idelalisib 50 mg tablet was administered orally twice daily each day until the end of treatment. BI 836826 was administered intravenously as a rate-controlled infusion. An initial dose of 10 mg was administered on Day 8. Doses of 50 mg were administered on Day 9 and Day 15. The full assigned dose of 100 mg was administered on Day 22, every 2 weeks thereafter through Week 18, and every 4 weeks thereafter through Week 46.
Skin and subcutaneous tissue disorders Cold sweat	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Skin and subcutaneous tissue disorders Dermatitis contact	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Skin and subcutaneous tissue disorders Hyperhidrosis	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Skin and subcutaneous tissue disorders Nail disorder	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Skin and subcutaneous tissue disorders Petechiae	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Skin and subcutaneous tissue disorders Photosensitivity reaction	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Skin and subcutaneous tissue disorders Rash	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Skin and subcutaneous tissue disorders Rash maculo-papular	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Skin and subcutaneous tissue disorders Skin lesion	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Blood and lymphatic system disorders Anaemia	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Blood and lymphatic system disorders Lymph node pain	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Blood and lymphatic system disorders Thrombocytopenia	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Gastrointestinal disorders Diarrhoea	100.0% 2/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Gastrointestinal disorders Dry mouth	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Gastrointestinal disorders Nausea	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
General disorders Fatigue	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
General disorders Infusion site bruising	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
General disorders Localised oedema	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
General disorders Oedema	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Infections and infestations Bronchitis	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Infections and infestations Parainfluenzae virus infection	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Infections and infestations Rhinovirus infection	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Infections and infestations Sinusitis	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Infections and infestations Upper respiratory tract infection	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Injury, poisoning and procedural complications Contusion	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Investigations Blood creatinine increased	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Investigations Blood lactate dehydrogenase increased	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Investigations Platelet count decreased	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Investigations Weight decreased	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Investigations Weight increased	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Metabolism and nutrition disorders Hyperkalaemia	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Musculoskeletal and connective tissue disorders Arthralgia	100.0% 2/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Musculoskeletal and connective tissue disorders Muscle spasms	100.0% 2/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Musculoskeletal and connective tissue disorders Myalgia	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Nervous system disorders Dizziness	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Cough	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Productive cough	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	50.0% 1/2 • From first dose date to study termination (up to approximately 18 months) The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment group designated according to the actual treatment received.

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER