Trial · NCT02538614
Study of Idelalisib in Combination With BI 836826 in Participants With Chronic Lymphocytic Leukemia
NCT02538614, Phase 1, Terminated, Gilead Sciences; results first posted 2020-11-25
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Idelalisib in Combination With BI 836826 in Participants With Chronic Lymphocytic Leukemia. Trials, record NCT02538614. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02538614
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Idelalisib in Combination With BI 836826 in Participants With Chronic Lymphocytic Leukemia
- NCT number
- NCT02538614
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 2 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Chronic Lymphocytic Leukemia (CLL)
- Interventions
- Idelalisib, BI 836826
- First posted
- 2015-09-02
- Last updated
- 2020-11-25
- Results first posted
- 2020-11-25
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b: Percentage of Participants Experienced Dose Limiting Toxicities (DLTs) During the First 7 Weeks of Study Therapy | Up to 7 weeks | 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. |
| Primary | For Phase 2: Complete Response Rate (CRR) | Up to 18 months | 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. |
| Primary | For Phase 2: Minimal Residual Disease (MRD) Negativity Rate in Bone Marrow by Week 50 | Week 50 | MRD defined as the percentage of participants with MRD \< 10\^-4, assessed by flow cytometry in bone marrow, achieved by Week 50. |
| Secondary | Phase 1b: Percentage of Participants Experienced DLTs During the Treatment Period | Up to 18 months | 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. |
| Secondary | For Phase 1b and Phase 2: Number of Participants Experiencing Any Serious Adverse Events (SAE) | Up to 18 months | 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. |
| Secondary | For Phase 1b and Phase 2: Number of Participants Who Permanently Discontinued Study Treatment Due to an Adverse Event | Up to 18 months | 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. |
| Secondary | For Phase 2: Overall Response Rate (ORR) | Up to 18 months | 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. |
| Secondary | For Phase 2: Duration of Complete Response (DCR) | Up to 18 months | 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. |
| Secondary | For Phase 2: Duration of Response (DOR) | Up to 18 months | 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. |
| Secondary | For Phase 2: Progression-Free Survival (PFS) | Up to 18 months | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1b: Percentage of Participants Experienced Dose Limiting Toxicities (DLTs) During the First 7 Weeks of Study Therapy | Up to 7 weeks | Due to early study termination this outcome measure was not assessed. | ||
| PRIMARY | For Phase 2: Complete Response Rate (CRR) | Up to 18 months | Due to early study termination this outcome measure was not assessed. | ||
| PRIMARY | For Phase 2: Minimal Residual Disease (MRD) Negativity Rate in Bone Marrow by Week 50 | Week 50 | Due to early study termination this outcome measure was not assessed. | ||
| SECONDARY | Phase 1b: Percentage of Participants Experienced DLTs During the Treatment Period | Up to 18 months | Due to early study termination this outcome measure was not assessed. | ||
| SECONDARY | For Phase 1b and Phase 2: Number of Participants Experiencing Any Serious Adverse Events (SAE) | Up to 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | For Phase 1b and Phase 2: Number of Participants Who Permanently Discontinued Study Treatment Due to an Adverse Event | Up to 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | For Phase 2: Overall Response Rate (ORR) | Up to 18 months | Due to early study termination this outcome measure was not assessed. | ||
| SECONDARY | For Phase 2: Duration of Complete Response (DCR) | Up to 18 months | Due to early study termination this outcome measure was not assessed. | ||
| SECONDARY | For Phase 2: Duration of Response (DOR) | Up to 18 months | Due to early study termination this outcome measure was not assessed. | ||
| SECONDARY | For Phase 2: Progression-Free Survival (PFS) | Up to 18 months | Due to early study termination this outcome measure was not assessed. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| For Phase 1b and Phase 2: Number of Participants Experiencing Any Serious Adverse Events (SAE) | Phase 1b and 2: Idelalisib + BI 836826 | 2 | Participants | ||
| For Phase 1b and Phase 2: Number of Participants Who Permanently Discontinued Study Treatment Due to an Adverse Event | Phase 1b and 2: Idelalisib + BI 836826 | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1b: Idelalisib + BI 836826 | 2 | |
| Overall Study | COMPLETED | Phase 1b: Idelalisib + BI 836826 | 0 | |
| Overall Study | NOT COMPLETED | Phase 1b: Idelalisib + BI 836826 | 2 |
Source ClinicalTrials.gov
Adverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Phase 1b: Idelalisib + BI 836826 | 1 | 2 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Phase 1b: Idelalisib + BI 836826 | 1 | 2 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase 1b: Idelalisib + BI 836826 | 1 | 2 | |
| other | Diarrhoea | Gastrointestinal disorders | Phase 1b: Idelalisib + BI 836826 | 2 | 2 | |
| other | Dry mouth | Gastrointestinal disorders | Phase 1b: Idelalisib + BI 836826 | 1 | 2 | |
| other | Nausea | Gastrointestinal disorders | Phase 1b: Idelalisib + BI 836826 | 1 | 2 | |
| other | Fatigue | General disorders | Phase 1b: Idelalisib + BI 836826 | 1 | 2 | |
| other | Infusion site bruising | General disorders | Phase 1b: Idelalisib + BI 836826 | 1 | 2 | |
| other | Localised oedema | General disorders | Phase 1b: Idelalisib + BI 836826 | 1 | 2 | |
| other | Oedema | General disorders | Phase 1b: Idelalisib + BI 836826 | 1 | 2 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1b: Idelalisib + BI 836826 | 0 | 2 |
| Total, other adverse events | Phase 1b: Idelalisib + BI 836826 | 2 | 2 |
| Total, serious adverse events | Phase 1b: Idelalisib + BI 836826 | 2 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02538614
GET https://conductscience.org/api/trials/v1/NCT02538614/events?page=2