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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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This study consists of 2 parts: Phase 1b and Phase 2. Phase 1b will evaluate the safety and tolerability of the combination of idelallisib with the anti-CD37 monoclonal antibody BI 836826 in participants with relapsed/refractory chronic lymphocytic leukemia (R/R CLL), and establish the high recommended Phase 2 combination dose (highRP2D) as well as an alternate lower recommended Phase 2 combination dose (lowRP2D). Phase 2 will determine the rates of complete response (CR) and of minimal residual disease (MRD) negativity with the combination at the highRP2D and the lowRP2D in participants with R/R CLL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1b: Idelalisib + BI 836826 | Experimental | Participants will receive escalating dose of idelalisib at dose levels, 50 mg, 100 mg, and 150 mg + BI 836826 10 mg on Day 8, 50 mg on Day 9 and Day 15, and 100 mg on Day 22, every 2 weeks through Week 18, and every 4 weeks through Week 46. 2 dose combinations (highRP2D and lowRP2D) will be determined for further evaluations in Phase 2. |
|
| Phase 2 Idelalisib + BI 836826 | Experimental | Participants will be randomly assigned to receive 1 of the 2 dose combinations selected from Phase 1b. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idelalisib | Drug | Tablets administered orally twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Percentage of Participants Experienced Dose Limiting Toxicities (DLTs) During the First 7 Weeks of Study Therapy | 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. | Up to 7 weeks |
| For Phase 2: Complete Response Rate (CRR) | 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. | Up to 18 months |
| For Phase 2: Minimal Residual Disease (MRD) Negativity Rate in Bone Marrow by Week 50 | MRD defined as the percentage of participants with MRD < 10^-4, assessed by flow cytometry in bone marrow, achieved by Week 50. | Week 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Percentage of Participants Experienced DLTs During the Treatment Period | 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. | Up to 18 months |
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Key Inclusion Criteria:
Diagnosis of B-cell CLL, established according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria and having received at least 2 prior treatment regimens
CLL that warrants treatment
Clinically quantifiable disease burden defined as:
For Phase 1b individuals: absolute lymphocyte count (ALC) > 5000/μL in peripheral blood.
For Phase 2 individuals either:
Discontinuation of all cytotoxic chemotherapy and anti-CD20 antibody therapy for ≥ 4 weeks, alemtuzumab for ≥ 8 weeks, targeted therapy for ≥ 2 weeks, and investigational therapy for ≥ 3 weeks before enrollment (Phase 1b) or randomization (Phase 2). For individuals with relapsed CLL most recently treated with B-cell receptor (BCR) pathway inhibitors who, in the opinion of the investigator, will not tolerate waiting 3 weeks, a washout period of > 5 half-lives is allowed. If on a systemic corticosteroid, the dose must be stable for the previous 4 weeks.
Eastern Cooperative Oncology Group (ECOG) score of ≤ 2
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University | Columbus | Ohio | United States | |||
| University of Utah |
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
18 months after study completion
A secured external environment with username, password, and RSA code.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The All Enrolled Analysis Set included all participants who were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 1b: Percentage of Participants Experienced Dose Limiting Toxicities (DLTs) During the First 7 Weeks of Study Therapy | 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. | Due to early study termination this outcome measure was not assessed. | Posted | Up to 7 weeks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 15, 2017 | Sep 14, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 28, 2017 | Sep 14, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C552946 | idelalisib |
| C000626798 | BI 836826 |
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Phase 1b: sequential assignment, Phase 2: parallel assignment
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| BI 836826 | Drug | Intravenous administration as a rate-controlled infusion |
|
| For Phase 1b and Phase 2: Number of Participants Experiencing Any Serious Adverse Events (SAE) | 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. | Up to 18 months |
| For Phase 1b and Phase 2: Number of Participants Who Permanently Discontinued Study Treatment Due to an Adverse Event | 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. | Up to 18 months |
| For Phase 2: Overall Response Rate (ORR) | 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. | Up to 18 months |
| For Phase 2: Duration of Complete Response (DCR) | 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. | Up to 18 months |
| For Phase 2: Duration of Response (DOR) | 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. | Up to 18 months |
| For Phase 2: Progression-Free Survival (PFS) | 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. | Up to 18 months |
| For Phase 2: Overall Survival (OS) | OS was defined as the interval from the randomization to the date of death from any cause. | Up to 18 months |
| For Phase 2: MRD Negativity Rate in Blood at Any Time | 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. | Up to 18 months |
| For Phase 2: MRD Negativity Rate in Bone Marrow at Any Time | 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. | Up to 18 months |
| Salt Lake City |
| Utah |
| United States |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | For Phase 2: Complete Response Rate (CRR) | 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. | Due to early study termination this outcome measure was not assessed. | Posted | Up to 18 months |
|
|
| Primary | For Phase 2: Minimal Residual Disease (MRD) Negativity Rate in Bone Marrow by Week 50 | MRD defined as the percentage of participants with MRD < 10^-4, assessed by flow cytometry in bone marrow, achieved by Week 50. | Due to early study termination this outcome measure was not assessed. | Posted | Week 50 |
|
|
| Secondary | Phase 1b: Percentage of Participants Experienced DLTs During the Treatment Period | 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. | Due to early study termination this outcome measure was not assessed. | Posted | Up to 18 months |
|
|
| Secondary | For Phase 1b and Phase 2: Number of Participants Experiencing Any Serious Adverse Events (SAE) | 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. | 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. | Posted | Count of Participants | Participants | Up to 18 months |
|
|
|
| Secondary | For Phase 1b and Phase 2: Number of Participants Who Permanently Discontinued Study Treatment Due to an Adverse Event | 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. | 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. | Posted | Count of Participants | Participants | Up to 18 months |
|
|
|
| Secondary | For Phase 2: Overall Response Rate (ORR) | 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. | Due to early study termination this outcome measure was not assessed. | Posted | Up to 18 months |
|
|
| Secondary | For Phase 2: Duration of Complete Response (DCR) | 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. | Due to early study termination this outcome measure was not assessed. | Posted | Up to 18 months |
|
|
| Secondary | For Phase 2: Duration of Response (DOR) | 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. | Due to early study termination this outcome measure was not assessed. | Posted | Up to 18 months |
|
|
| Secondary | For Phase 2: Progression-Free Survival (PFS) | 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. | Due to early study termination this outcome measure was not assessed. | Posted | Up to 18 months |
|
|
| Secondary | For Phase 2: Overall Survival (OS) | OS was defined as the interval from the randomization to the date of death from any cause. | Due to early study termination this outcome measure was not assessed. | Posted | Up to 18 months |
|
|
| Secondary | For Phase 2: MRD Negativity Rate in Blood at Any Time | 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. | Due to early study termination this outcome measure was not assessed. | Posted | Up to 18 months |
|
|
| Secondary | For Phase 2: MRD Negativity Rate in Bone Marrow at Any Time | 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. | Due to early study termination this outcome measure was not assessed. | Posted | Up to 18 months |
|
|
| 0 |
| 2 |
| 2 |
| 2 |
| 2 |
| 2 |
| Aspartate aminotransferase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Lymph node pain | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Infusion site bruising | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Localised oedema | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Parainfluenzae virus infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Rhinovirus infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
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:
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |