Description:
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.
Title
- Brief Title: Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
GS-US-312-0133
- SECONDARY ID:
2013-003314-41
- NCT ID:
NCT02044822
Conditions
- B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion
Interventions
Drug | Synonyms | Arms |
---|
Idelalisib | GS-1101, CAL-101, Zydelig® | Idelalisib + rituximab |
Rituximab | Rituxan | Idelalisib + rituximab |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Idelalisib + rituximab | Experimental | Participants will receive rituximab for 8 weeks and Idelalisib continuously throughout the study (up to 10 years). | |
Eligibility Criteria
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall Response Rate |
Time Frame: | |
Safety Issue: | |
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 Outcome Measures
Measure: | Duration of Response |
Time Frame: | |
Safety Issue: | |
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. |
Measure: | Nodal Response Rate |
Time Frame: | |
Safety Issue: | |
Description: | Nodal response rate was defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC. |
Measure: | Complete Response Rate |
Time Frame: | |
Safety Issue: | |
Description: | Complete response rate was defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC. |
Measure: | Progression-Free Survival |
Time Frame: | |
Safety Issue: | |
Description: | Progression-free survival (PFS) was defined as the interval from first dose of study drug to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an IRC. |
Measure: | Overall Survival |
Time Frame: | |
Safety Issue: | |
Description: | Overall survival was defined as the interval from the start of study treatment to death from any cause. |
Measure: | Minimal Residual Disease Negativity Rate at Week 36 |
Time Frame: | |
Safety Issue: | |
Description: | Minimal residual disease (MRD) negativity rate was defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation. For participants receiving the final dose of rituximab after the original scheduled date, the MRD assessment will be performed no fewer than 12 weeks after the last dose of rituximab. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Gilead Sciences |
Trial Keywords
- Chronic Lymphocytic Leukemia
- CLL
Last Updated
November 19, 2018