Efficacy and Safety Study of Idelalisib in Patients With Indolent B-Cell Non-Hodgkin Lymphoma (DELTA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01282424
First received: January 21, 2011
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to evaluate the efficacy and safety of idelalisib in patients with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. 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 taken twice per day. Treatment with idelalisib can continue in compliant patients as long as the study is still ongoing and the patients appear to be benefiting from treatment with acceptable safety.


Condition Intervention Phase
Indolent Non-Hodgkin Lymphoma
Follicular Lymphoma
Small Lymphocytic Lymphoma
Lymphoplasmacytoid Lymphoma
Marginal Zone 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 CAL-101 in Patients With Indolent B-Cell Non-Hodgkin Lymphoma Refractory to Rituximab and Alkylating Agents

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Overall Response Rate during treatment with idelalisib based on standard criteria [ Time Frame: Every 8-12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of Response [ Time Frame: Every 8-12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the sum of the product of the greatest perpendicular diameters of the target lymph nodes [ Time Frame: Every 8-12 weeks ] [ Designated as safety issue: No ]
  • Time to Treatment Response [ Time Frame: Every 8-12 weeks ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: Every 8-12 weeks ] [ Designated as safety issue: No ]
  • Time to Treatment Failure [ Time Frame: Every 8-12 weeks ] [ Designated as safety issue: No ]
  • Changes in health-related quality of life events [ Time Frame: Every 4-12 weeks ] [ Designated as safety issue: No ]
  • Changes in performance status [ Time Frame: Every 4-12 weeks ] [ Designated as safety issue: No ]
  • Changes in plasma concentrations of disease-associated chemokines and cytokines [ Time Frame: Every 2-12 weeks ] [ Designated as safety issue: No ]
  • Overall safety profile of idelalisib [ Time Frame: Every 2-12 weeks ] [ Designated as safety issue: Yes ]
  • Study Drug administration and compliance [ Time Frame: Every 4-12 weeks ] [ Designated as safety issue: No ]
  • Idelalisib plasma exposure over time [ Time Frame: Every 4-8 weeks for 16 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters for patients participating in sub-study [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: May 2011
Estimated Study Completion Date: October 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Idelalisib Drug: Idelalisib
Idelalisib 150 mg taken twice daily by mouth
Other Names:
  • GS-1101
  • CAL-101

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Karnofsky performance score 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
    • Lymphoplasmacytoid 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

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. Patients 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 patient, alter the absorption, distribution, metabolism or excretion of the study drug, or impair the assessment of study results
  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: NCT01282424

  Show 55 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Wayne Godfrey, MD Gilead Sciences
  More Information

No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01282424     History of Changes
Other Study ID Numbers: 101-09, 2010-022155-33
Study First Received: January 21, 2011
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
indolent Non-Hodgkin Lymphoma
Non-Hodgkin Lymphoma
iNHL
NHL
GS-1101
CAL-101
PI3K
Phosphatidylinositol 3-kinase
Follicular Lymphoma (FL)
Small lymphocytic lymphoma (SLL)
Lymphoplasmacytoid lymphoma (LPL)
Marginal zone lymphoma (MZL)

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Waldenstrom Macroglobulinemia
Lymphoma, B-Cell
Lymphoma, B-Cell, Marginal Zone
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014