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Dose Optimization Study of Idelalisib in Follicular Lymphoma

This study is currently recruiting participants.
Verified September 2017 by Gilead Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT02536300
First Posted: August 31, 2015
Last Update Posted: October 2, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
  Purpose
This study will optimize the safety and efficacy of chronic administration of idelalisib in participants with follicular lymphoma (FL) and evaluate the overall safety profile of idelalisib and the overall response rate (ORR) by Week 24.

Condition Intervention Phase
Follicular Lymphoma Drug: Idelalisib Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Dose Optimization Study of Idelalisib in Follicular Lymphoma

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Overall safety profile of idelalisib, including the incidence of adverse events and clinically significant laboratory abnormalities [ Time Frame: Up to 5 years ]
  • Overall response rate (ORR) by Week 24 [ Time Frame: Up to Week 24 ]
    Overall response rate is defined as the proportion of participants who achieve a partial response (PR) or complete response (CR) by Week 24.


Secondary Outcome Measures:
  • Time to onset of adverse events (AEs) of interest [ Time Frame: Up to 5 years ]
    Time to onset of AEs of interest (Grade ≥ 3 diarrhea/colitis, pneumonitis, ≥ Grade 3 transaminase elevation and rash) is defined as the interval from the start of idelalisib treatment to the first documentation of start of AE of interest.

  • Rate of AE of interest [ Time Frame: Up to 5 years ]
    Rate of AE of interest defined as the number of participants with AE of interest

  • Rate of drug interruptions for the number of participants with AE of interest [ Time Frame: Up to 5 years ]
    Rate of drug interruptions for the number of participants with AE of interest

  • Progression-free survival (PFS) [ Time Frame: Up to 5 years ]
    Progression-free survival is defined as the interval from randomization to the earlier of the first documentation of disease progression by independent review committee (IRC) or death from any cause

  • Duration of response (DOR) [ Time Frame: Up to 5 years ]
    Duration of response defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of disease progression by IRC or death from any cause

  • Overall survival (OS) [ Time Frame: Up to 5 years ]
    Overall survival defined as the interval from randomization to death from any cause

  • Idelalisib trough (pre-dose) and peak (1.5-hour samples) plasma concentrations [ Time Frame: Predose and 1.5 hours postdose in the morning ]

Estimated Enrollment: 240
Actual Study Start Date: January 14, 2016
Estimated Study Completion Date: May 2023
Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Idelalisib 150 mg
Participants will receive idelalisib 150 mg twice daily. Based on the 8-week blinded independent review committee (IRC) response assessment, participants may be discontinued from the study or may receive blinded or open-label idelalisib 150 mg twice daily.
Drug: Idelalisib
Idelalisib tablet administered orally
Other Names:
  • Zydelig®
  • GS-1101
  • CAL-101
Experimental: Idelalisib 100 mg
Participants will receive idelalisib 100 mg twice daily. Based on the 8-week blinded IRC response assessment, participants may either be dose escalated to open-label 150 mg twice daily or maintain blind and continue on idelalisib 100 mg twice daily.
Drug: Idelalisib
Idelalisib tablet administered orally
Other Names:
  • Zydelig®
  • GS-1101
  • CAL-101

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Histologically confirmed diagnosis of B-cell follicular lymphoma (FL), and grade limited to 1, 2, or 3a based on criteria established by the WHO 2008 classification of tumors of hematopoietic and lymphoid tissues
  • Refractory to and disease progression within 6 months from the last dose of at least 2 lines of prior therapy
  • Ann-Arbor Stage 2 (non-contiguous), 3, or 4 disease per Lugano Classification Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures ≥ 1.5 cm in the longest dimension (LD) and ≥ 1.0 cm in the longest perpendicular dimension (LPD) as assessed by positron emission tomography-computed tomography (PET-CT), computed tomography (CT) or magnetic resonance imaging (MRI)
  • Required baseline central laboratory data in protocol.
  • For female individuals of childbearing potential and male individuals of reproductive potential, willingness to use a protocol- recommended method of contraception
  • Lactating females must agree to discontinue nursing
  • Willing and able to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions including mandatory prophylaxis for Pneumocystis jirovecii pneumonia (PJP)

Key Exclusion Criteria:

  • History of lymphoid malignancy other than FL (eg, diffuse large B-cell lymphoma)
  • Known history of, or clinically apparent, central nervous system (CNS) lymphoma or leptomeningeal lymphoma.
  • Known presence of intermediate- or high-grade myelodysplastic syndrome.
  • Known history of serious allergic reaction including anaphylaxis or Stevens- Johnson syndrome/ toxic epidermal necrolysis
  • History of a non-lymphoid malignancy except for protocol allowed exceptions
  • Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
  • Known history of drug-induced liver injury, chronic active hepatitis B virus (HBV), chronic active hepatitis C virus (HCV), alcoholic liver disease, non-alcoholic steatohepatitis, cirrhosis of the liver, portal hypertension, primary biliary cirrhosis, or ongoing extrahepatic obstruction caused by cholelithiasis
  • History of or ongoing drug-induced pneumonitis
  • History of or ongoing inflammatory bowel disease
  • Known human immunodeficiency virus (HIV) infection
  • History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
  • Ongoing immunosuppressive therapy, including systemic corticosteroids (> 10 mg prednisone or equivalent/day) with the exception of the use of topical, enteric, or inhaled corticosteroids as therapy for comorbid conditions and systemic steroids for autoimmune anemia and/or thrombocytopenia
  • Concurrent participation in another therapeutic clinical trial
  • Prior treatment with phosphatidylinositol 3-kinase (PI3K) delta inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, janus kinase inhibitor (JAK) inhibitors, mammalian target of rapamycin (mTOR) inhibitors, or spleen tyrosine kinase (Syk) inhibitors
  • Cytomegalovirus (CMV)- Ongoing infection, treatment, or prophylaxis within the past 28 days

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

  Contacts and Locations
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): NCT02536300


Contacts
Contact: Gilead Study Team 1580studymailbox@gilead.com

  Show 67 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02536300     History of Changes
Other Study ID Numbers: GS-US-313-1580
2015-000366-66 ( EudraCT Number )
First Submitted: August 27, 2015
First Posted: August 31, 2015
Last Update Posted: October 2, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Idelalisib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action