Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01393106
First received: July 11, 2011
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Hodgkin Lymphoma
Drug: Idelalisib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Overall response rate (ORR) is defined as the proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) during idelalisib treatment; response definitions will be based on standard criteria.


Secondary Outcome Measures:
  • Duration of response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Duration of response (DOR) is defined as the interval from the first documentation of PR or CR to the earlier of the first documentation of disease progression or death from any cause.

  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in fluorodeoxyglucose (FDG) uptake in lymph nodes as assessed by positron-emission tomography (PET) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Time to treatment response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Time to treatment response (TTR) is defined as the interval from the start of idelalisib treatment to the first documentation of CR or PR.

  • Progression free survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Progression free survival (PFS) is defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression or death from any cause.

  • Time to treatment failure [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Time to treatment failure (TTF) is defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression, the permanent cessation of idelalisib therapy due to an adverse event, or death from any cause.

  • 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 ] [ Designated as safety issue: No ]
  • Changes in performance status [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Changes in performance status will be assessed using the Karnofsky performance criteria for participants ≥ 16 years of age and the Lansky performance criteria for participants < 16 years of age.

  • Changes in the plasma concentrations of disease-associated chemokines and cytokines [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    This composite endpoint will measure the overall safety profile of idelalisib.

  • 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 ] [ Designated as safety issue: No ]
  • Idelalisib trough and peak plasma concentrations [ Time Frame: Predose and 1.5 hours postdose ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Idelalisib
Participants will receive up to 300 mg of idelalisib twice daily.
Drug: Idelalisib
Idelalisib tablets administered orally
Other Names:
  • Zydelig®
  • GS-1101
  • CAL-101

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393106

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Wayne Godfrey, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01393106     History of Changes
Other Study ID Numbers: 101-11
Study First Received: July 11, 2011
Last Updated: September 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HL
idelalisib
CAL-101
GS-1101
PI3K

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on October 01, 2014