TriangleNCT01282424 · REGISTRY CONDITION SEARCH
Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2019-07-11
The primary objective will be to assess the overall response rate and to evaluate the efficacy and safety of idelalisib (IDELA; GS-1101) in participants with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg taken twice per day. Treatment with idelalisib can continue in compliant participants as long as the study is still ongoing and the participants appear to be benefiting from treatment with acceptable safety.
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.
Participant flow
Baseline characteristics
Overall Response Rate
Duration of Response
Lymph Node Response Rate
Time to Response
Progression-Free Survival
Overall Survival
Change in Health-Related Quality of Life Using the Functional Assessment of Cancer Therapy: Lymphoma Subscale (FACT-LymS)
Change in Karnofsky Performance Status
Changes in Plasma Concentrations of Disease-Associated Chemokines and Cytokines
Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms
Study Drug Exposure
Idelalisib Plasma Concentration
PK Parameter: Cmax
PK Parameter: Tmax
PK Parameter: AUClast
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Key Inclusion Criteria: * Karnofsky performance status of ≥ 60 (Eastern Cooperative Oncology Group \[ECOG\] performance score of 0, 1, or 2) * Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following: * Follicular lymphoma (FL) * Small lymphocytic lymphoma (SLL) with absolute lymphocyte count \< 5 x 10\^9/L at the time of diagnosis and on baseline laboratory assessment performed within 4 weeks prior to the start of study drug administration * Lymphoplasmacytic lymphoma (LPL), with or without associated Waldenstroms Macroglobulinemia (WM) * Marginal zone lymphoma (MZL) (splenic, nodal, or extranodal) * Prior treatment with ≥ 2 prior chemotherapy-based or immunotherapy-based regimens for iNHL * Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy * Prior treatment with rituximab and with an alkylating agent (eg, bendamustine, cyclophosphamide, ifosfamide, chlorambucil, melphalan, busulfan, nitrosoureas) for iNHL * Lymphoma that is refractory to rituximab and to an alkylating agent * Discontinuation of all other therapies for treatment of iNHL ≥ 3 weeks before Visit 2 * For men and women of childbearing potential, willingness to abstain from sexual intercourse or employ an effective method of contraception during the study drug administration and follow-up periods * Willingness and ability to provide written informed consent and to comply with the protocol requirements Key Exclusion Criteria: * Central nervous system or leptomeningeal lymphoma * Known histological transformation from iNHL to diffuse large B-cell lymphoma * History of a non-lymphoma malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, localized prostate cancer, other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ≥ 5 years * Evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral upper respiratory tract infections) at the time of initiation of study treatment * Pregnancy or breastfeeding * Ongoing alcohol or drug addiction * Known history of drug-induced liver injury, chronic active hepatitis B infection, chronic active hepatitis C infection, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver, or portal hypertension * History of prior allogeneic bone marrow progenitor cell or solid organ transplantation * Ongoing immunosuppressive therapy, including systemic corticosteroids. Participant may be using topical or inhaled corticosteroids. * Prior therapy with idelalisib * Exposure to another investigational drug within 3 weeks prior to start of study treatment * Concurrent participation in another therapeutic treatment trial * Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, ECG finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant, alter the absorption, distribution, metabolism or excretion of the study drug, or impair the assessment of study results 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
- Treatment with idelalisib will be continued until tumor progression or development of unacceptable toxicity.
- intervention Names
- Drug: Idelalisib
- label
- Idelalisib
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Idelalisib
- description
- Idelalisib 150 mg tablet administered orally twice daily
- name
- Idelalisib
- other Names
- Zydelig®
- GS-1101
- CAL-101
- IDELA
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 125
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the percentage of participants achieving a complete response (CR) or partial response (PR; or minor response \[MR\] for participants with WM) as assessed by the study independent review committee (IRC). CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions. For WM only, response was defined as a reduction in immunoglobulin M (IgM) of ≥ 50% decrease for PR, and ≥ 25% decrease for MR; no increase from baseline in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions or signs and symptoms of active disease (Owen, 2013)
- measure
- Overall Response Rate
- time Frame
- Start of Treatment to End of Treatment (up to 81 months)
- secondary Outcomes
- description
- Duration of Response (DOR) was defined as the interval from the first documentation of CR or PR (or MR for participants with WM) to the earlier of the first documentation of disease progression as assessed by the study IRC or death from any cause. DOR was analyzed using Kaplan-Meier (KM) estimates.
- measure
- Duration of Response
- time Frame
- Start of Treatment to End of Treatment (up to 81 months)
- description
- Lymph node response (LNR) was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the product of the perpendicular diameters (SPD) of measurable index lesions as assessed by the study IRC.
- measure
- Lymph Node Response Rate
- time Frame
- Start of Treatment to End of Treatment (up to 81 months)
- description
- Time to response (TTR) was defined as the interval from the start of idelalisib treatment to the first documentation of CR or PR (or MR for participants with WM) as assessed by the study IRC.
- measure
- Time to Response
- time Frame
- Start of Treatment to End of Treatment (up to 81 months)
- description
- Progression-free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression as assessed by the study IRC or death from any cause. PFS was analyzed using KM estimates.
- measure
- Progression-Free Survival
- time Frame
- Start of Treatment to End of Treatment (up to 81 months)
- description
- Overall survival (OS) was defined as the time interval from the start of idelalisib treatment to death from any cause. OS was analyzed using KM estimates.
- measure
- Overall Survival
- time Frame
- Start of Treatment to Last Long-Term Follow-Up Visit (up to maximum of 7 years)
- description
- Change in health-related quality of life events were reported by participants using the Functional Assessment of Cancer Therapy: Lymphoma Subscale (FACT-LymS) assessment tool. Results are presented as the mean (SD) best change from baseline. The best change from baseline was defined as the highest change score (improvement) after baseline. The FACT-LymS is on a scale from 0-60, with higher scores associated with a better quality of life. It incorporates values from 15 questions, each rated 0-4, related to study indications.
- measure
- Change in Health-Related Quality of Life Using the Functional Assessment of Cancer Therapy: Lymphoma Subscale (FACT-LymS)
- time Frame
- Baseline to End of Treatment (up to 81 months)
- description
- The change in Karnofsky performance status was reported as the best (highest change score) and worst (lowest change score) change from baseline using the Karnofsky performance criteria. The Karnofsky score classified participants according to their functional impairment. Scores are on a scale from 0-100, the lower the score, the worse the survival for most serious illnesses.
- measure
- Change in Karnofsky Performance Status
- time Frame
- Baseline to End of Treatment (up to 81 months)
- description
- Analysis of the cytokine/chemokine was planned to be performed on a subset of samples from this study along with a subset of samples from other studies. Therefore, data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
- measure
- Changes in Plasma Concentrations of Disease-Associated Chemokines and Cytokines
- time Frame
- Enrollment to End of Treatment (up to 81 months)
- description
- This composite endpoint measured the safety and tolerability profile of idelalisib. "Clinically meaningful" abnormalities in vital signs and electrocardiograms (ECG) were as determined by the investigator.
- measure
- Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms
- time Frame
- Start of Treatment to End of Treatment (up to 81 months) plus 30 days
- description
- The average idelalisib exposure was summarized.
- measure
- Study Drug Exposure
- time Frame
- Start of Treatment to End of Treatment (up to 81 months)
- measure
- Idelalisib Plasma Concentration
- time Frame
- Predose and at 1.5 hours (± 5 minutes) postdose on Day 29
- description
- Cmax at Days 1 and 29 was analyzed. Cmax is defined as the maximum concentration of drug.
- measure
- PK Parameter: Cmax
- time Frame
- Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29
Full study description
- brief Summary
- The primary objective will be to assess the overall response rate and to evaluate the efficacy and safety of idelalisib (IDELA; GS-1101) in participants with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg taken twice per day. Treatment with idelalisib can continue in compliant participants as long as the study is still ongoing and the participants appear to be benefiting from treatment with acceptable safety.
Source references
- references
- citation
- Salles GA, Kahl, BS, Wagner-Johnston ND, et al. Interim results from a phase 2 study of PI3Kδ inhibitor idelalisib in patients with relapsed indolent non-Hodgki lymphoma (iNHL) refractory to both rituximab and an alkylating agent. 12th International Conference on Malignant Lymphoma, Palazzo dei Congressi, Lugano, Switzerland, June 19-22, 2013 Abstract No: 064bis.
- type
- RESULT
- citation
- Gopal AK, Kahl BS, de Vos S, Wagner-Johnston ND, Schuster SJ, Jurczak WJ, Flinn IW, Flowers CR, Martin P, Viardot A, Blum KA, Goy AH, Davies AJ, Zinzani PL, Dreyling M, Johnson D, Miller LL, Holes L, Li D, Dansey RD, Godfrey WR, Salles GA. PI3Kdelta inhibition by idelalisib in patients with relapsed indolent lymphoma. N Engl J Med. 2014 Mar 13;370(11):1008-18. doi: 10.1056/NEJMoa1314583. Epub 2014 Jan 22.
- pmid
- 24450858
- type
- RESULT
- citation
- Ma S, Chan RJ, Gu L, Xing G, Rajakumaraswamy N, Ruzicka BB, Wagner-Johnston ND. Retrospective Analysis of the Impact of Adverse Event-Triggered Idelalisib Interruption and Dose Reduction on Clinical Outcomes in Patients With Relapsed/Refractory B-Cell Malignancies. Clin Lymphoma Myeloma Leuk. 2021 May;21(5):e432-e448. doi: 10.1016/j.clml.2020.12.016. Epub 2020 Dec 24.
- pmid
- 33516721
- type
- DERIVED
- citation
- Barrientos JC, Hillmen P, Salles G, Sharman J, Stilgenbauer S, Gurtovaya O, Xing G, Ruzicka B, Bhargava P, Ghia P, Pagel JM. No increased bleeding events in patients with relapsed chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma treated with idelalisib. Leuk Lymphoma. 2021 Apr;62(4):837-845. doi: 10.1080/10428194.2020.1845339. Epub 2020 Dec 10.
- pmid
- 33297794
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice