TriangleNCT01539512 · CITED IN SOURCE DOCUMENTS
A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2019-05-14
This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- Inclusion: * Adult subjects with previously treated recurrent CLL who have measurable lymphadenopathy * Require therapy for CLL * Have experienced CLL progression \< 24 months since the completion of the last prior therapy * Currently not sufficiently fit to receive cytotoxic therapy because of chemotherapy-induced bone marrow damage or comorbidities.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants will receive idelalisib plus rituximab
- intervention Names
- Drug: Idelalisib
- Drug: Rituximab
- label
- Idelalisib + rituximab
- type
- ACTIVE_COMPARATOR
- description
- Participants will receive placebo to match idelalisib plus rituximab
- intervention Names
- Drug: Rituximab
- Drug: Placebo to match idelalisib
- label
- Placebo + rituximab
- type
- PLACEBO_COMPARATOR
- interventions
- arm Group Labels
- Idelalisib + rituximab
- description
- Idelalisib 150 mg tablet administered orally twice daily
- name
- Idelalisib
- other Names
- Zydelig®
- GS-1101
- CAL 101
- type
- DRUG
- arm Group Labels
- Idelalisib + rituximab
- Placebo + rituximab
- description
- Rituximab administered intravenously 8 times through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter
- name
- Rituximab
- other Names
- Rituxan®
- type
- DRUG
- arm Group Labels
- Placebo + rituximab
- description
- Placebo to match idelalisib administered orally twice daily
- name
- Placebo to match idelalisib
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- TRIPLE
- who Masked
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 220
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Progression-free survival 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 CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL.
- measure
- Progression-Free Survival
- time Frame
- Up to 17 months
- secondary Outcomes
- description
- Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response. Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate \& biopsy. Partial response was defined as \>1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, \> 100000/μL platelets, \> 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors.
- measure
- Overall Response Rate
- time Frame
- Up to 17 months
- description
- Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the SPD of index lymph nodes.
- measure
- Lymph Node Response Rate
- time Frame
- Up to 17 months
- description
- Overall survival was defined as the interval from randomization to death from any cause.
- measure
- Overall Survival
- time Frame
- Up to 17 months
- description
- Complete response rate was defined as the percentage of participants who achieved a complete response.
- measure
- Complete Response Rate
- time Frame
- Up to 17 months
Full study description
- brief Summary
- This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.
Source references
- references
- citation
- Barrientos JC, Hillmen P, Salles G, Sharman J, Stilgenbauer S, Gurtovaya O, Xing G, Ruzicka B, Bhargava P, Ghia P, Pagel JM. No increased bleeding events in patients with relapsed chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma treated with idelalisib. Leuk Lymphoma. 2021 Apr;62(4):837-845. doi: 10.1080/10428194.2020.1845339. Epub 2020 Dec 10.
- pmid
- 33297794
- type
- DERIVED
- citation
- Gordon MJ, Huang J, Chan RJ, Bhargava P, Danilov AV. Medical comorbidities in patients with chronic lymphocytic leukaemia treated with idelalisib: analysis of two large randomised clinical trials. Br J Haematol. 2021 Feb;192(4):720-728. doi: 10.1111/bjh.16879. Epub 2020 Jun 29.
- pmid
- 32599655
- type
- DERIVED
- citation
- Furman RR, Sharman JP, Coutre SE, Cheson BD, Pagel JM, Hillmen P, Barrientos JC, Zelenetz AD, Kipps TJ, Flinn I, Ghia P, Eradat H, Ervin T, Lamanna N, Coiffier B, Pettitt AR, Ma S, Stilgenbauer S, Cramer P, Aiello M, Johnson DM, Miller LL, Li D, Jahn TM, Dansey RD, Hallek M, O'Brien SM. Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. N Engl J Med. 2014 Mar 13;370(11):997-1007. doi: 10.1056/NEJMoa1315226. Epub 2014 Jan 22.
- pmid
- 24450857
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- 14 CLINICAL STUDIES Zydelig was evaluated in a randomized, double-blind, placebo-controlled study GS-US-312-0116 (referred to as 312-0116) (NCT01539512) in 220 patients with relapsed CLL who required treatment and were unable to tolerate standard chemoimmunotherapy due to coexisting medical conditions, reduced
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Preserved source evidence · Not medical advice