Trial · NCT02538614
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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. |
| Secondary | For Phase 2: Overall Survival (OS) | Up to 18 months | OS was defined as the interval from the randomization to the date of death from any cause. |
| Secondary | For Phase 2: MRD Negativity Rate in Blood at Any Time | Up to 18 months | 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. |
| Secondary | For Phase 2: MRD Negativity Rate in Bone Marrow at Any Time | Up to 18 months | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT02538614/registered