TriangleNCT01732913 · CITED IN SOURCE DOCUMENTS
Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
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
- TERMINATED
- Registry last update
- 2018-11-16
The primary objective of this study is to evaluate the effect of the addition of idelalisib to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line 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 this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).
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
- Key Inclusion Criteria: * Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following: 1. Follicular lymphoma (FL) Grade 1, 2, or 3a 2. Small lymphocytic lymphoma (SLL) with absolute lymphocyte count \< 5 x 10\^9/L at the time of diagnosis 3. Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM) 4. Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal) Key Exclusion Criteria: * History of lymphoid malignancy other than those allowed per inclusion criteria * Ongoing drug-induced liver injury, active hepatitis C, active hepatitis B , alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension. * Received previous treatment with rituximab that was not effective. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants will receive rituximab + idelalisib.
- intervention Names
- Drug: Rituximab
- Drug: Idelalisib
- label
- Rituximab + idelalisib
- type
- EXPERIMENTAL
- description
- Participants will receive rituximab + placebo. Following confirmation of iNHL disease progression by the independent review committee and unblinding, participants may be eligible to receive open-label idelalisib 150 mg twice daily.
- intervention Names
- Drug: Placebo
- Drug: Rituximab
- Drug: Idelalisib
- label
- Rituximab + Placebo
- type
- PLACEBO_COMPARATOR
- interventions
- arm Group Labels
- Rituximab + Placebo
- description
- Tablets administered orally twice daily
- name
- Placebo
- type
- DRUG
- arm Group Labels
- Rituximab + Placebo
- Rituximab + idelalisib
- description
- 375 mg/m\^2 administered intravenously weekly for 4 weeks, then every 8 weeks (up to a total of 8 infusions)
- name
- Rituximab
- other Names
- Rituxan®
- MabThera®
- type
- DRUG
- arm Group Labels
- Rituximab + Placebo
- Rituximab + idelalisib
- description
- 150 mg tablets administered orally twice daily
- name
- Idelalisib
- other Names
- GS-1101
- CAL-101
- Zydelig®
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- TRIPLE
- who Masked
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 295
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphoma (iNHL) disease progression or death from any cause. PFS was to be assessed by an independent review committee (IRC).
- measure
- Progression Free Survival
- secondary Outcomes
- description
- Overall Response Rate (ORR) is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response or minor response for participants with Waldenstrom's). ORR was to be assessed by an IRC.
- measure
- Overall Response Rate
- description
- Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.
- measure
- Lymph Node Response Rate
- description
- Complete response rate is defined as the proportion of participants who achieve a complete response. Complete response rate was to be assessed by an IRC.
- measure
- Complete Response Rate
- description
- Overall survival is defined as the interval from randomization to death from any cause.
- measure
- Overall Survival
Full study description
- brief Summary
- The primary objective of this study is to evaluate the effect of the addition of idelalisib to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line 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 this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-aabda2ebc3d78d78f5d1
- requested nct id
- NCT01732913
- primary nct id
- NCT01732913
- source kind
- fda_spl_label
- source record id
- ca3e7112-6dfe-403f-af6f-a0051e77d125
- source file sha256
- a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
- payload sha256
- 1712bd4ec370368bfa97bf232c53b15da0093d3365082bb2c3b36a7ac6fd4002
- payload
- application numbers
- NDA205858
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-aabda2ebc3d78d78f5d1
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT01732913
- occurrences
- context exact
- 312-0123 (NCT01980888), 311 patients with previously untreated CLL received up to 6 cycles of BR with or without Zydelig 150 mg twice daily. In Study 313-0124 (NCT01732913), 295 patients with previously treated iNHL [FL 66%, marginal zone lymphoma (MZL) 19%, SLL 9%, lymphoplasmacytic lymphoma (LPL)/Waldenstrom macroglobulinemia (
- end
- 10376
- exact text
- NCT01732913
- start
- 10365
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00600.json
- source file sha256
- a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
- source json pointer
- /results/66/adverse_reactions/0
- source kind
- fda_spl_label
- source record id
- ca3e7112-6dfe-403f-af6f-a0051e77d125
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- f01b4769db899a9d9372acd0f33a6bf22de26134e2166b59a73683f3e43e3379
- spl effective time
- 20250220
- spl set id
- efbdafa9-d18c-4e85-b4a2-1e620fc74e50
Preserved source evidence · Not medical advice