Clinical trial · Interventional
Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
A Phase 2, Single Arm Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion. An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Idelalisib | Drug | Idelalisib | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Idelalisib + rituximab
- description
- Participants will receive rituximab for 8 weeks and Idelalisib continuously throughout the study (up to 10 years).
- interventionNames
- Drug: Idelalisib
- Drug: Rituximab
Primary outcomes (1)
- measure
- Overall Response Rate
- description
- Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an independent review committee (IRC).
Secondary outcomes (6)
- measure
- Duration of Response
- description
- Duration of response (DOR) was defined as the interval from the first documentation of confirmed complete response or partial response (by IRC) to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is chronic lymphocytic leukemia (CLL) progression based on standard criteria, excluding lymphocytosis alone.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Documented diagnosis of B-cell CLL, according to International Workshop on Chronic Lymphocytic Leukemia 2008 * Presence of 17p deletion in CLL cells as demonstrated by fluorescence in-situ hybridization (FISH) testing * No prior therapy for CLL other than corticosteroids for disease complications * CLL that warrants treatment * Presence of measurable lymphadenopathy * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 Key Exclusion Criteria: * Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation) * Known presence of myelodysplastic syndrome * History of a non-CLL malignancy except for the following: * the malignancy has been in remission without treatment for ≥ 5 years prior to enrollment, or * carcinoma in situ of the cervix, or * adequately treated basal or squamous cell skin cancer or other localized non-melanoma skin cancer, or * asymptomatic prostate cancer without known metastatic disease and with no current requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ≥ 1 year prior to enrollment, or * ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone, or * other adequately treated Stage 1 or 2 cancer currently in complete remission * Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment * Ongoing liver injury * History of noninfectious pneumonitis * Ongoing inflammatory bowel disease * History of prior allogeneic bone marrow progenitor cell or solid organ transplantation * Ongoing immunosuppressive therapy other than corticosteroids * Received last dose of study drug on another therapeutic clinical trial within 30 days prior to enrollment * Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram (ECG) finding, or laboratory abnormality Note: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (0)
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