Phase 2 Study of Idelalisib in Indolent B-Cell Non-Hodgkin Lymphoma

Phase 1

• Conditions: Indolent B-Cell Non-Hodgkin Lymphoma; MedDRA version: 20.0 Level: PT Classification code 10029601 Term: Non-Hodgkin's lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-022155-33-GB
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-03
• Study Completion: 2018-05-16
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 125

Inclusion Criteria

Patients must meet all of the following conditions to be eligible for enrollment into the study:
1. Age =18 years.
2. Karnofsky performance score of =60 (Eastern Cooperative Oncology Group [ECOG] performance score of 0, 1, or 2).
3. Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following based on criteria established by the World Health Organization (WHO) 2008 classification of tumors of haematopoietic and lymphoid tissues:
- Follicular lymphoma (FL) Grade 1, 2, or 3a
- 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
- Lymphoplasmacytoid lymphoma (LPL) with or without associated Waldenstroms Macroglobulinemia (WM)
- Marginal zone lymphoma (MZL) (splenic, nodal, or extranodal)
4. Histological materials documenting diagnosis of lymphoma available for review.
5. Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of =1 lesion that measures >2 cm in the longest dimension [LD] and =1.0 cm in the longest perpendicular dimension [LPD] as assessed by CT or MRI)
6. Prior treatment with =2 prior chemotherapy- or immunotherapy-based regimens for iNHL.
7. Prior treatment with rituximab and with an alkylating agent (eg, bendamustine, cyclophosphamide, ifosfamide, chlorambucil, melphalan, busulfan, nitrosoureas) for iNHL.
8. Lymphoma that is refractory to rituximab and to an alkylating agent. Please refer to Study Protocol section 4.1.1 for the definition of refractoriness.
9. Discontinuation of all other therapies (including radiotherapy or chemotherapy) for the treatment of iNHL =3 weeks before initiation of study treatment (Visit 2).
10. All acute toxic effects of any prior antitumor therapy resolved to Grade =1 before initiation of study treatment (Visit 2) (with the exception of alopecia [Grade =2 permitted], neurotoxicity [Grade =2 permitted], or bone marrow parameters noted in Table 1 of protocol section 4.1.1 [Grade =2 permitted]).
11. Required baseline laboratory data (within 4 weeks prior to start of study drug administration) as shown in Table 1 (see Study Protocol section 4.1.1).
12. For men and women of childbearing potential (ie, patients who are not postmenopausal or surgically sterile), willingness to abstain from sexual intercourse or employ an effective method of contraception during the study drug administration and follow-up periods.
13. Willingness and ability to provide written informed consent and to comply with scheduled visits, drug administration plan, imaging studies and contrast dye administration, laboratory tests, other study procedures, and study restrictions.
14. Evidence of a personally signed informed consent indicating that the patient is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, possible side effects, potential risks and discomforts, and other pertinent aspects of study participation.

Exclusion Criteria

The presence of any of the following conditions will exclude a patient from study enrollment:
1. Central nervous system or leptomeningeal lymphoma.
2. Known histological transformation from iNHL to diffuse large B-cell lymphoma.
3. 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.
4. 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).
5. Pregnancy or breastfeeding.
6. Ongoing alcohol or drug addiction.
7. Known history of drug-induced liver injury, chronic active HCV, chronic active HBV, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver or portal hypertension.
8. History of prior allogeneic bone marrow progenitor cell or solid organ transplantation.
9. Ongoing immunosuppressive therapy, including systemic corticosteroids.
10. Prior therapy with CAL-101
11. Exposure to another investigational drug within 3 weeks prior to start of study treatment.
12. Concurrent participation in another therapeutic treatment trial.
13. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified