Clinical Trials /

Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion

NCT02044822

Description:

The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion. An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.

Related Conditions:
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

Efficacy and Safety of Idelalisib in Combination With <span class="go-doc-concept go-doc-intervention">Rituximab</span> in Patients With Previously Untreated <span class="go-doc-concept go-doc-disease">Chronic Lymphocytic Leukemia</span> With <span class="go-doc-concept go-doc-keyword">17p</span> <span class="go-doc-concept go-doc-keyword">Deletion</span>

Title

  • Brief Title: Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
  • Official Title: 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
  • Clinical Trial IDs

    NCT ID: NCT02044822

    ORG ID: GS-US-312-0133

    NCI ID: 2013-003314-41

    Trial Conditions

    B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion

    Trial Interventions

    Drug Synonyms Arms
    Idelalisib GS-1101, CAL-101, Zydelig Idelalisib + rituximab
    Rituximab Rituxan Idelalisib + rituximab

    Trial Purpose

    This study will evaluate the effect of treatment with idelalisib (IDELA) plus rituximab on
    overall response rate (ORR); onset, magnitude, and duration of disease control (including
    duration of response [DOR], progression free survival [PFS], and overall survival [OS]); and
    minimal residual disease (MRD) in subjects with previously untreated chronic lymphocytic
    leukemia (CLL) with 17p deletion. In addition, the study will evaluate the safety profile
    observed with the combination of IDELA and rituximab.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Idelalisib + rituximab Experimental Participants will receive rituximab for 8 weeks and Idelalisib continuously throughout the study (up to 10 years). Idelalisib, Rituximab

    Eligibility Criteria

    Inclusion Criteria:

    - Documented diagnosis of B-cell CLL, according to International Workshop on Chronic
    Lymphocytic Leukemia 2008

    - Presence of 17p deletion in CLL cells as demonstrated by FISH testing

    - No prior therapy for CLL other than corticosteroids for disease complications.

    - CLL that warrants treatment

    - Presence of measurable lymphadenopathy

    - Eastern Cooperative Oncology Group (ECOG) performance status of 2

    Exclusion Criteria:

    - Known histological transformation from CLL to an aggressive lymphoma (ie, Richter
    transformation).

    - Known presence of myelodysplastic syndrome.

    - History of a non-CLL malignancy except for the following:

    - the malignancy has been in remission without treatment for 5 years prior to
    enrollment, or

    - carcinoma in situ of the cervix, or

    - adequately treated basal or squamous cell skin cancer or other localized
    non-melanoma skin cancer, or

    - 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

    - ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone, or

    - other adequately treated Stage 1 or 2 cancer currently in complete remission

    - Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of
    enrollment

    - Ongoing liver injury

    - History of noninfectious pneumonitis.

    - Ongoing inflammatory bowel disease.

    - History of prior allogeneic bone marrow progenitor cell or solid organ
    transplantation.

    - Ongoing immunosuppressive therapy other than corticosteroids.

    - Received last dose of study drug on another therapeutic clinical trial within 30 days
    prior to enrollment.

    - Prior or ongoing clinically significant illness, medical condition, surgical history,
    physical finding, electrocardiogram (ECG) finding, or laboratory abnormality

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Overall Response Rate

    Secondary Outcome Measures

    Duration of Response

    Complete Response Rate

    Progression-free survival

    Minimal residual disease negativity rate

    Nodal response rate

    Overall survival

    Trial Keywords

    Chronic Lymphocytic Leukemia

    CLL