Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin Lymphoma

NCT01393106 | Completed Phase 2 Results

• 1 other identifier: 101-11
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

This study will evaluate the efficacy and safety of idelalisib in participants with relapsed of refractory Hodgkin Lymphoma (HL). The primary objective will be to assess the overall response rate. Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg twice daily. Treatment with idelalisib will continue until tumor progression or unacceptable toxicity.

Conditions

Hodgkin Lymphoma

Keywords

HL; idelalisib; CAL-101; GS-1101; PI3K

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  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 proportion of participants achieving a complete response (CR) or partial response (PR) as assessed by the investigator. * 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.

  Up to Week 110

Secondary Outcomes (13)

• Duration of Response

  Up to Week 110

• Percent Change From Baseline in the Sum of the Product of the Greatest Perpendicular Diameters (SPD) of Target Lymph Nodes as Documented Radiographically

  Baseline, Week 8, Week 48, and up to Week 110

• Change From Baseline in Fluorodeoxyglucose (FDG) Uptake in Lymph Nodes as Assessed by Positron-emission Tomography (PET)

  Up to Week 110

• Time to Response

  Up to Week 110

• Overall Survival

  Up to Week 110

Study Arms (1)

Idelalisib

EXPERIMENTAL

Participants will receive up to 300 mg of idelalisib twice daily.

Drug: Idelalisib

Interventions

Idelalisib DRUG

Idelalisib tablets administered orally

Also known as: Zydelig®, GS-1101, CAL-101

Idelalisib

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 12 years
• Karnofsky performance score of ≥ 60 (Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2)
• Histologically confirmed diagnosis of classic HL (ie, nodular sclerosis, mixed cellularity, lymphocyte depleted, and or lymphocyte rich types)
• Nodal HL that shows fluorodeoxyglucose (FDG) avidity (defined as focal or diffuse FDG uptake above background in a location incompatible with normal anatomy or physiology), and is measurable (defined as the presence of ≥ 1 nodal lesion that measures ≥ 2 cm in a single dimension as assessed by CT, PET/CT, or magnetic resonance imaging (MRI))
• Relapsed or refractory HL after prior myeloablative therapy with autologous stem cell transplantation (ASCT) or after ≥ 2 prior chemotherapy-containing regimens and no curative option with conventional therapy
• Discontinuation of all radiotherapy or chemotherapy for the treatment of HL greater than or equal to 3 weeks before initiation of study treatment and discontinuation of all radioimmunotherapy for HL (Visit 2)
• All acute toxic effects (excluding alopecia, neurotoxicity, or anemia) of any prior antitumor therapy resolved to Grade ≤ 2 before initiation of study treatment (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 protocol requirements

You may not qualify if:

• Known active central nervous system or leptomeningeal 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 (Visit 2)
• Pregnancy or breastfeeding
• Ongoing alcohol or drug addiction
• Known history of drug-induced liver injury, chronic active hepatitis C virus (HCV), chronic active hepatitis B virus (HBV), 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.
• 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 patient; alter the absorption, distribution, metabolism or excretion of the study drug; or impair the assessment of study results
• Prior therapy with any drug that inhibits Akt, Bruton tyrosine kinase (BTK), Janus kinase (JAK), mammalian target of rapamycin (mTOR), phosphatidylinositol 3 kinase (PI3K) (including idelalisib), or spleen tyrosine kinase (SYK)

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (3)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Gopal AK, Fanale MA, Moskowitz CH, Shustov AR, Mitra S, Ye W, Younes A, Moskowitz AJ. Phase II study of idelalisib, a selective inhibitor of PI3Kdelta, for relapsed/refractory classical Hodgkin lymphoma. Ann Oncol. 2017 May 1;28(5):1057-1063. doi: 10.1093/annonc/mdx028.

  PMID: 28327905 DERIVED

MeSH Terms

Conditions

Hodgkin Disease

Interventions

idelalisib

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Limitations and Caveats

There were no limitations affecting the analysis or results.

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences

ClinicalTrialDisclosures@gilead.com

Study Officials

• Lyndah Dreiling, MD

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 13, 2011
• Study Start: September 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 19, 2018
• Results First Posted: December 24, 2015

Record last verified: 2015-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

US (3)