A Phase 2, Single Arm Study Evaluating the Efficacy and Safety of Idelalisib in Combination with Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia with 17p Deletion

Gilead Sciences, Inc.0 sites100 target enrollmentSeptember 23, 2014

ConditionsChronic Lymphocytic Leukemia with 17p deletion MedDRA version: 18.0Level: LLTClassification code 10068919Term: B-cell chronic lymphocytic leukemiaSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsZydelig MabThera 500 mg concentrate for solution for infusion

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic Lymphocytic Leukemia with 17p deletion
Sponsor: Gilead Sciences, Inc.
Enrollment: 100
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 23, 2014

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Gilead Sciences, Inc.

Eligibility Criteria

Inclusion Criteria

•1\) Male or female \=18 years of age.
•2\) Documented diagnosis of B\-cell CLL, according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008\.
•3\) Presence of 17p deletion in CLL cells as demonstrated by FISH testing performed at a central laboratory.
•4\) No prior therapy for CLL other than corticosteroids for disease complications.
•5\) CLL that warrants treatment based on pre\-defined criteria.
•6\) Presence of measurable lymphadenopathy confirmed by the Independent Review Committee (IRC) (defined as the presence of \=1 nodal lesion that measures \=2\.0 cm in the longest dimension \[LD] and \=1\.0 cm in the longest perpendicular dimension \[LPD] as assessed by computed tomography \[CT] or magnetic resonance imaging \[MRI]).
•7\) ECOG performance status of \=2\.
•8\) Required baseline laboratory data (within 28 days prior to enrollment) as shown in the protocol.
•9\) For female subjects of childbearing potential, willing to use a protocol\-recommended method of contraception from the signing of informed consent throughout the study treatment period and up to 30 days from the last dose of IDELA or 12 months from the last dose of rituximab, whichever is later.
•10\) Male subjects of reproductive potential having intercourse with females of childbearing potential, must agree to utilize protocol specified methods of contraception and refrain from sperm donation from the enrollment visit throughout the study treatment period and up to 3 months from the last dose of IDELA or 12 months from the last dose of rituximab, whichever is later.

Exclusion Criteria

•1\) Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation).
•2\) Known presence of myelodysplastic syndrome.
•3\) History of a non\-CLL malignancy with the following exceptions:
•a) the malignancy has been in remission without treatment for \=5 years prior to enrollment, or
•b) carcinoma in situ of the cervix, or
•c) adequately treated basal or squamous cell skin cancer or other localized non\-melanoma skin cancer, or
•d) asymptomatic prostate cancer without known metastatic disease and with no current requirement for therapy or requiring only hormonal therapy and with normal prostate\-specific antigen for \=1 year prior to enrollment, or
•e) DCIS of the breast treated with lumpectomy alone, or
•f) Other adequately treated Stage 1 or 2 cancer currently in complete remission.
•4\) Known hypersensitivity or intolerance to any of the active substances or excipients in the formulations for IDELA, or rituximab.