Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Participants With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01088048
Recruitment Status : Completed
First Posted : March 17, 2010
Results First Posted : March 18, 2021
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Indolent Non-Hodgkin's Lymphoma Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Drug: Idelalisib Drug: Rituximab Drug: Bendamustine Drug: Ofatumumab Drug: Fludarabine Drug: Everolimus Drug: Bortezomib Drug: Chlorambucil Drug: Lenalidomide Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 25, 2010
Actual Primary Completion Date : April 28, 2015
Actual Study Completion Date : April 28, 2015


Arm Intervention/treatment
Experimental: Idelalisib + Rituximab

Participants with chronic lymphocytic leukemia (CLL) and indolent non-Hodgkin lymphoma (iNHL) will receive treatments as follows:

Cohort 1a: Idelalisib (IDELA) 100 mg orally twice daily (BID) on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 intravenously (IV) on Days 1, 8, 15 & 22, Cycles 1 & 2

Cohort 2a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2

Cohort 3e: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2

Cohort 4a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle, starting Cycle 2 Day 1 with the 5th dose of rituximab + rituximab 375 mg/m^2 IV on Days 1, 8, 15, & 22, Cycles 1 & 2

Drug: Idelalisib
Idelalisib tablet administered orally
Other Names:
  • GS-1101
  • CAL-101
  • Zydelig®

Drug: Rituximab
Rituximab administered intravenously
Other Name: Rituxan

Experimental: Idelalisib + Rituximab + Bendamustine

Participants with CLL, iNHL and mantle cell lymphoma (MCL) will receive treatments as follows:

Cohort 3a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6

Cohort 3b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle from Cycles 1 - 6

Cohort 5c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6

Drug: Idelalisib
Idelalisib tablet administered orally
Other Names:
  • GS-1101
  • CAL-101
  • Zydelig®

Drug: Rituximab
Rituximab administered intravenously
Other Name: Rituxan

Drug: Bendamustine
Bendamustine administered intravenously
Other Name: Treanda

Experimental: Idelalisib + Bendamustine

Participants with CLL and iNHL will receive treatments as follows:

Cohort 1b: IDELA 100 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6

Cohort 2b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6

Cohort 3f: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6

Cohort 3g: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bendamustine 70 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6

Cohort 4b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle starting Cycle 2, Day 3 (after the Cycle 2 bendamustine dosing) + bendamustine 90 mg/m^2 IV on Days 1 & 2 of each 28-day cycle, Cycles 1 - 6

Drug: Idelalisib
Idelalisib tablet administered orally
Other Names:
  • GS-1101
  • CAL-101
  • Zydelig®

Drug: Bendamustine
Bendamustine administered intravenously
Other Name: Treanda

Experimental: Idelalisib + Ofatumumab

Participants with CLL will receive treatments as follows:

Cohort 3c: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + ofatumumab 12 doses (300 mg (Day 1 or Day 2, Dose 1), followed 1 week later by 1,000 mg weekly for 7 doses (Doses 2 - 8), followed 5 weeks later by 1,000 mg every 4 weeks for 4 doses (Doses 9 - 12))

Drug: Idelalisib
Idelalisib tablet administered orally
Other Names:
  • GS-1101
  • CAL-101
  • Zydelig®

Drug: Ofatumumab
Ofatumumab administered intravenously
Other Name: Arzerra

Experimental: Idelalisib + Fludarabine

Participants with CLL will receive treatments as follows:

Cohort 3d: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + fludarabine 40 mg/m^2 orally on Days 1 - 5 of each 28-day cycle, Cycles 1 - 6

Drug: Idelalisib
Idelalisib tablet administered orally
Other Names:
  • GS-1101
  • CAL-101
  • Zydelig®

Drug: Fludarabine
Fludarabine administered orally
Other Name: Fludara

Experimental: Idelalisib + Everolimus

Participants with MCL will receive treatments as follows:

Cohort 5a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + everolimus 10 mg orally once daily on Days 1 - 28 of each 28-day cycle

Drug: Idelalisib
Idelalisib tablet administered orally
Other Names:
  • GS-1101
  • CAL-101
  • Zydelig®

Drug: Everolimus
Everolimus administered orally twice daily until disease progression
Other Names:
  • Afinitor
  • RAD-001

Experimental: Idelalisib + Bortezomib

Participants with MCL will receive treatments as follows:

Cohort 5b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + bortezomib 1.3 mg/m^2 subcutaneously on Days 1, 8 & 15 of each 28-day cycle

Drug: Idelalisib
Idelalisib tablet administered orally
Other Names:
  • GS-1101
  • CAL-101
  • Zydelig®

Drug: Bortezomib
Bortezomib administered as a subcutaneous injection
Other Names:
  • Velcade
  • codenamed PS-341

Experimental: Idelalisib + Chlorambucil

Participants with CLL will receive treatments as follows:

Cohort 6a: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12

Drug: Idelalisib
Idelalisib tablet administered orally
Other Names:
  • GS-1101
  • CAL-101
  • Zydelig®

Drug: Chlorambucil
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 Name: Leukeran

Experimental: Idelalisib + Rituximab + Chlorambucil

Participants with CLL will receive treatments as follows:

Cohort 6b: IDELA 150 mg orally BID on Days 1 - 28 of each 28-day cycle + rituximab 375 mg/m^2 IV on Day 1 of each 28-day cycle, Cycles 1 - 6 + chlorambucil 10 mg/m^2 orally once daily for 7 days every 28 days, Cycles 1 - 12

Drug: Idelalisib
Idelalisib tablet administered orally
Other Names:
  • GS-1101
  • CAL-101
  • Zydelig®

Drug: Rituximab
Rituximab administered intravenously
Other Name: Rituxan

Drug: Chlorambucil
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 Name: Leukeran

Experimental: Idelalisib + Rituximab + Lenalidomide

Participants with CLL and iNHL will receive treatments as follows:

Cohort 7a: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) & Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of Cycle 1 & Day 1 of Cycles 2 - 6 + lenalidomide 5 mg orally once daily on Days 8 - 28 of Cycle 1 (35 days) & Days 1 - 21 of next five 28-day cycles

Cohort 7b: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) & Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of Cycle 1 & Day 1 of Cycles 2 - 6 + lenalidomide 10 mg orally once daily on Days 8 - 28 of Cycle 1 (35 days) & Days 1 - 21 of next five 28-day cycles

Cohort 7c: IDELA 150 mg orally BID on Days 1 - 35 of Cycle 1 (35 days) & Days 1 - 28 of all subsequent 28-day cycles + rituximab 375 mg/m^2 IV on Days 1 & 8 of Cycle 1 & Day 1 of Cycles 2 - 6 + lenalidomide 20 mg orally once daily on Days 8 - 28 of Cycle 1 (35 days) & Days 1 - 21 of next five 28-day cycles

Drug: Idelalisib
Idelalisib tablet administered orally
Other Names:
  • GS-1101
  • CAL-101
  • Zydelig®

Drug: Rituximab
Rituximab administered intravenously
Other Name: Rituxan

Drug: Lenalidomide
Lenalidomide administered orally
Other Name: Revlimid




Primary Outcome Measures :
  1. Duration of Exposure to IDELA [ Time Frame: First dose date up to 12 months ]
    Duration of exposure to IDELA was summarized using descriptive statistics.

  2. Toxicity of Administration of IDELA [ 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


Secondary Outcome Measures :
  1. Overall Response Rate [ 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:

    • CLL: International Workshop on chronic lymphocytic leukemia (IWCLL),2008
    • iNHL & MCL: Cheson, 2007

  2. Duration of Response [ 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.

  3. Time to Response [ 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.

  4. Progression-free Survival [ 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:

    • CLL: International Workshop on chronic lymphocytic leukemia (IWCLL), 2008
    • iNHL & MCL: Cheson, 2007

  5. Overall Survival [ 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.

  6. Plasma Concentration of IDELA (Cohort 1, Cohorts 2 and 3, Cohort 5) [ 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 ]
  7. Plasma Concentration of IDELA (Cohort 4) [ 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 ]
  8. Plasma Concentration of IDELA (Cohort 6) [ Time Frame: Predose, 1.5 hours postdose at Weeks 0, 4, 12 and 24 ]
  9. Plasma Concentration of IDELA (Cohort 7) [ Time Frame: Predose, 1.5 hours postdose at Weeks 0, 5 and 13 ]
  10. Sub-study: Plasma Concentration of IDELA (Cohorts 1-4) [ Time Frame: pre dose and 0.5, 1, 1.5, 2.0, 3.0, 4.0, and 6.0 hours post dose ]
  11. Plasma Concentration of Bendamustine [ 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 ]
  12. Plasma Concentration of Everolimus [ Time Frame: Predose, 1.5 hours postdose at Weeks 0 and 4 ]
  13. Plasma Concentration of Lenalidomide [ Time Frame: Predose, 1.5 hours postdose at Week 1 and predose at Week 5 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Age ≥ 18
  • Previously treated with relapsed or refractory disease (refractory defined as not responding to a standard regimen or progressing within 6 months of the last course of a standard regimen)
  • Disease status requirement:

    • For CLL patients, symptomatic disease that mandates treatment as defined by the International Workshop on Chronic Lymphocytic Lymphoma (IWCLL) 2008 criteria
    • For indolent NHL and MCL patients, measurable disease by CT scan defined as at least 1 lesion that measures > 2 cm in a single dimension
  • WHO performance status of ≤ 2
  • For men and women of child-bearing potential, willing to use adequate contraception (ie, latex condom, cervical cap, diaphragm, abstinence, etc.) for the entire duration of the study.

    • For Cohort 7 only: Women of child bearing potential must have 2 negative pregnancy tests prior to starting lenalidomide.
  • Able to provide written informed consent

Key Exclusion Criteria:

  • Is not a good candidate to receive any of the drugs administered in the study for a given disease (idelalisib, bendamustine, rituximab, ofatumumab, fludarabine, everolimus, bortezomib, or chlorambucil), according to the clinical judgment of the investigator
  • Patients with atypical immunophenotype with t(11:14) translocation or cyclin D1 over-expression (CLL patients only)
  • Had radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or treatment with an investigational product within 4-weeks prior to the baseline disease status tests
  • Had treatment with a short course of corticosteroids for symptom relief within 1-week prior to the baseline disease status tests
  • Has had an allogeneic hematopoietic stem cell transplant
  • Has known active central nervous system involvement of the malignancy
  • Is pregnant or nursing
  • Has active, serious infection requiring systemic therapy. Patients may receive prophylactic antibiotics and antiviral therapy at the discretion of the investigator
  • Has absolute neutrophil count (ANC) < 1000/µL, unless it is related to underlying CLL, MCL or indolent NHL, the latter documented by > 50% infiltration of bone marrow by tumor cells
  • Has platelet count < 75000/µL, unless it is related to underlying CLL, MCL, or iNHL, the latter documented by > 50% infiltration of bone marrow by tumor cells
  • Has serum creatinine ≥ 2.0 mg/dL

    • For Cohort 7 only: Has creatinine clearance < 60 mL/min
  • Has serum bilirubin ≥ 2 mg/dL (unless due to Gilbert's syndrome) for patients with iNHL or CLL; for patients with MCL, serum bilirubin ≥ 1.5 x upper limit of normal
  • Has serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≥ 2 x upper limit of normal
  • Has Child-Pugh Class B or C hepatic impairment
  • Has a positive test for HIV antibodies
  • Has active hepatitis B or C (confirmed by RNA test). Patients with serologic evidence of prior exposure are eligible.
  • Prior treatment with idelalisib

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01088048


Locations
Layout table for location information
United States, Alabama
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
United States, California
UCLA
Los Angeles, California, United States, 90024
Stanford Cancer Center
Palo Alto, California, United States, 94304-5548
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Weill Medical College of Cornell
New York, New York, United States, 10021
United States, Oregon
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, United States, 97477
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer
Houston, Texas, United States, 77030
United States, Washington
North Star Lodge Cancer Center
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Gilead Sciences
Investigators
Layout table for investigator information
Study Director: Gilead Study Director Gilead Sciences
Publications of Results:
Barrientos JC, Coutre SE, de Vos S, et al. Long-term follow-up of a Phase 1b trial of idelalisib in combination with chemoimmunotherapy in patients with relapsed/refractory chronic lymphocytic leukemia including patients with del17p/TP53 mutation. 51st Annual Meeting of the American Society of Clinical Oncology (ASCO). 29 May-02 June 2015; Chicago, IL, USA. [Poster 7011].
Barrientos J, Coutre S, de Vos S, et al. Long-term follow-up of a Phase 1 study evaluating the selective PI3K-delta inhibitor idelalisib in combination with bendamustine (B), bendamustine/rituximab (BR), fludarabine (F), chlorambucil (Chl), Or chlorambucil/rituximab (ChlR) in patients with relapsed or refractory chronic lymphocytic leukemia. Society of Hematology (ASH) Annual Meeting. December 6-9, 2014; San Francisco, CA, USA. Poster 3343.
de Vos S, Wagner-Johnston N, Coutre S, et al. Durable responses following treatment with the PI3K-delta inhibitor idelalisib in combination with rituximab, bendamustine, or both, in recurrent indolent non-Hodgkin lymphoma: Phase I/II results. Society of Hematology (ASH) Annual Meeting. December 6-9, 2014; San Francisco, CA, USA. Poster 3063.
Barrientos J, Leonard J, Furman R, Flinn I, De Vos S, Coutre S, et al. Phase 1b study of idelalisib (GS-1101) plus chlorambucil ± rituximab in patients with relapsed and refractory chronic lymphocytic leukemia (CLL). European Hematology Association (EHA) 2013 Congress, 13-16 June 2013; Stockholm, Sweden. Abstract P100.
Barrientos J, Sharman J, De Vos S, et al. GS-1101 (CAL-101), selective phosphatidylinositol 3-Kinase inhibitor, in combination with ofatumumab for treatment of relapsed/refractory chronic lymphocytic leukemia. European Hematology Association (EHA) 2012 Congress, 14-17 June 2012; Amsterdam, The Netherlands. Abstract 1062.
Coutre S, Leonard J, Furman R, et al. Combinations of the selective phosphatidylinositol 3 Kinase-delta (PI3Kd) inhibitor GS-1101 (CAL-101) with rituximab and/or bendamustine are tolerable and highly active in patients with relapsed or refractory chronic lymphocytic leukemia (CLL): results from a phase 1 study. American Society of Hematology (ASH) Annual Meeting. 8-11 December 2012; Atlanta, GA, USA. Abstract 642.
de Vos S, Schreeder M, Finn I, et al. A phase 1 study of the selective phosphatidylinositol 3 Kinase-delta (PI3Kd) inhibitor CAL-101 (GS-1101) in combination with rituximab and/or bendamustine in patients with relapsed or refractory indolent non-Hodgkin lymphoma (iNHL). American Society of Hematology (ASH) 2011 Annual Meeting, 10-13 December 2011; San Diego, CA, USA. Abstract 2699.
Flinn I, Schreeder M, Wagner-Johnson N, et al. A phase 1 study of CAL-101, an isoform-selective inhibitor of phosphatidylinositol 3-Kinase P110δ, in combination with rituximab and/or bendamustine in patients with relapsed or refractory B-cell malignancies. American Society of Hematology (ASH) 2010 Annual Meeting, 04-07 December 2010; Orlando, FL, USA. Blood (ASH Annual Meeting Abstracts) 2010 116: Abstract 2832.
Flinn I, Schreeder M, Coutre S, et al. A phase 1 study of CAL-101, an isoform-selective inhibitor of phosphatidylinositol 3-Kinase P110δ, in combination with anti-CD20 monoclonal antibody therapy and/or bendamustine in patients with previously treated B-cell malignancies. 47th Annual Meeting of the American Society of Clinical Oncology (ASCO). 04-08 June 2011; Chicago, IL, USA. [Poster 3064].
Fowler N, de Vos S, Schreeder M, et al. Combinations of the phosphatidylinositol 3 Kinase delta (PI3Kd) inhibitor idelalisib (GS-1101) with rituximab and/or bendamustine are tolerable and highly active in previously treated, indolent non-Hodgkin lymphoma: results from a phase 1 study. American Society of Hematology (ASH) 2012.
Furman R, Barrientos J, Sharman J, et al. A phase 1/2 study of the selective phosphatidylinositol 3-Kinase-delta (PI3Kd) inhibitor CAL-101 (GS-1101) with ofatumumab in patients with previously treated chronic lymphocytic leukemia (CLL). [Poster 6518] 2012 American Society of Clinical Oncology (ASCO) Annual Meeting; 01 05 June, 2012; Chicago, IL, USA. Gilead Sciences, Inc. [Poster 6518].
Sharman J, de Vos S, Leonard J, et al. A phase 1 study of the selective phosphatidylinositol 3-Kinase-delta (PI3Kd) inhibitor CAL-101 (GS-1101) in combination with rituximab and/or bendamustine in patients with relapsed or refractory chronic lymphocytic leukemia. American Society of Hematology (ASH) 2011 Annual Meeting, 10-13 December 2011; San Diego, CA, USA. Abstract 1787.
Wagner-Johnston ND, De Vos S, Leonard J, Sharman JP, Schreeder MT, Boccia RV, et al. Preliminary results of PI3Kδ inhibitor idelalisib (GS-1101) treatment in combination with everolimus, bortezomib, or bendamustine/rituximab in patients with previously treated mantle cell lymphoma (MCL) [Abstract 8501]. J Clin Oncol (ASCO Annual Meeting Abstracts) 2013;31 (suppl).

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01088048    
Other Study ID Numbers: 101-07
First Posted: March 17, 2010    Key Record Dates
Results First Posted: March 18, 2021
Last Update Posted: March 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gilead Sciences:
phosphatidylinositol 3-kinase
Ofatumumab
indolent non-Hodgkin lymphoma (iNHL)
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Leukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Rituximab
Fludarabine
Lenalidomide
Everolimus
Bortezomib
Bendamustine Hydrochloride
Ofatumumab
Idelalisib
Chlorambucil
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents