idelalisib
DrugIdelalisib tablet administered orally
Other names: GS-1101, CAL-101, Zydelig®
NCT Number: NCT01088048
The primary objective of the study is to evaluate the safety of idelalisib in combination with an anti-CD20 monoclonal antibody (mAb), a chemotherapeutic agent, a mammalian target of rapamycin (mTOR) inhibitor, a protease inhibitor, an antiangiogenic agent, and/or an immunomodulatory agent in participants with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL).
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Clearview Cancer Institute, Huntsville, Alabama, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Idelalisib tablet administered orally
Other names: GS-1101, CAL-101, Zydelig®
Rituximab administered intravenously
Other names: Rituxan
Bendamustine administered intravenously
Other names: Treanda
Ofatumumab administered intravenously
Other names: Arzerra
Fludarabine administered orally
Other names: Fludara
Everolimus administered orally twice daily until disease progression
Other names: Afinitor, RAD-001
Bortezomib administered as a subcutaneous injection
Other names: Velcade, codenamed PS-341
Chlorambucil administered on Days 1-7 every 28 days to allow appropriate therapy for participants with CLL and to coordinate into a cycle period equivalent to other study treatment regimens.
Other names: Leukeran
Lenalidomide administered orally
Other names: Revlimid
Time frame: First dose date up to 12 months
Duration of exposure to IDELA was summarized using descriptive statistics.
Time frame: First dose date up to 5 years
Percentage of participants experiencing toxicities of administration of IDELA were measured according to the Common Terminology Criteria for Adverse Events v4.02
Time frame: Up to 5 years
Overall Response Rate (ORR) was defined as the percentage of participants achieving a complete response (CR) or partial response (PR).
The response definitions were based on the following standard criteria established for each indication:
Time frame: Up to 5 years
Duration of response (DOR) was defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of disease progression or death from any cause.
Time frame: Up to 5 years
Time to response (TTR) was defined as the interval from the start of study drug to the first documentation of CR or PR.
Time frame: Up to 5 years
Progression free survival (PFS) was defined as the interval from the start of study drug to the earlier of the first documentation of disease progression or death from any cause.
The response definitions were based on the following standard criteria established for each indication:
Time frame: Up to 5 years
Overall Survival (OS) was defined as the interval from the start of study drug to death from any cause.
Time frame: Predose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 hours postdose at Week 0; predose, 1.5 hours postdose at Weeks 4, 12, and 24
Time frame: Predose at Week 0; predose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 hours postdose at Week 4; predose, 1.5 hours postdose at Week 12; and predose, 1.5 hours postdose at Week 24
Time frame: Predose, 1.5 hours postdose at Weeks 0, 4, 12 and 24
Time frame: Predose, 1.5 hours postdose at Weeks 0, 5 and 13
Time frame: pre dose and 0.5, 1, 1.5, 2.0, 3.0, 4.0, and 6.0 hours post dose
Time frame: Predose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0 hours postdose at Week 0
Time frame: Predose, 1.5 hours postdose at Weeks 0 and 4
Time frame: Predose, 1.5 hours postdose at Week 1 and predose at Week 5
Gilead Sciences
Industry
A Phase I Study to Investigate the Safety and Clinical Activity of Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 mAb in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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