This trial is active, not recruiting.

Condition hodgkin lymphoma
Treatment idelalisib
Phase phase 2
Target PI3K
Sponsor Gilead Sciences
Start date October 2011
End date August 2014
Trial size 25 participants
Trial identifier NCT01393106, 101-11


The study will evaluate the efficacy and safety of idelalisib (CAL-101, GS-1101) in participants with relapsed of refractory Hodgkin Lymphoma (HL). The primary objective will be to assess the overall response rate.

Eligible patients 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Participants will receive up to 300 mg of idelalisib twice daily.
idelalisib Zydelig®
Idelalisib tablets administered orally

Primary Outcomes

Overall response rate
time frame: Up to 3 years

Secondary Outcomes

Duration of response
time frame: Up to 3 years
Percent change from baseline in the sum of the product of the greatest perpendicular diameters (SPD) of target lymph nodes as documented radiographically
time frame: Up to 3 years
Change from baseline in fluorodeoxyglucose (FDG) uptake in lymph nodes as assessed by positron-emission tomography (PET)
time frame: Up to 3 years
Time to treatment response
time frame: Up to 3 years
Progression free survival
time frame: Up to 3 years
Time to treatment failure
time frame: Up to 3 years
Changes in health-related quality of life events as reported using the Functional Assessment of Cancer Therapy: Lymphoma (FACT-Lym) questionnaire
time frame: Up to 3 years
Changes in performance status
time frame: Up to 3 years
Changes in the plasma concentrations of disease-associated chemokines and cytokines
time frame: Up to 3 years
Type, frequency, severity, timing, and relationship to study therapy of any adverse events or abnormalities of physical findings, laboratory tests, or ECGs; drug discontinuations due to adverse events; or serious adverse events
time frame: Up to 3 years
Study drug administration as assessed by prescribing records and compliance as assessed by quantification of used and unused drug
time frame: Up to 3 years
Idelalisib trough and peak plasma concentrations
time frame: Predose and 1.5 hours postdose

Eligibility Criteria

Male or female participants at least 12 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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)

Additional Information

Official title A Phase 2 Study to Assess the Efficacy and Safety of GS-1101 (CAL-101) in Patients With Relapsed or Refractory Hodgkin Lymphoma
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Gilead Sciences.