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

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ClinicalTrials.gov Identifier: NCT02044822
Recruitment Status : Terminated
First Posted : January 24, 2014
Results First Posted : May 11, 2017
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE January 22, 2014
First Posted Date  ICMJE January 24, 2014
Results First Submitted Date  ICMJE March 30, 2017
Results First Posted Date  ICMJE May 11, 2017
Last Update Posted Date November 19, 2018
Actual Study Start Date  ICMJE August 6, 2014
Actual Primary Completion Date April 27, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2017)
Overall Response Rate
Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an independent review committee (IRC).
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2014)
Overall Response Rate [ Time Frame: Up to 10 years ]
Overall response rate (ORR) is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR).
Change History Complete list of historical versions of study NCT02044822 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2017)
  • Duration of Response
    Duration of response (DOR) was defined as the interval from the first documentation of confirmed complete response or partial response (by IRC) to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is chronic lymphocytic leukemia (CLL) progression based on standard criteria, excluding lymphocytosis alone.
  • Nodal Response Rate
    Nodal response rate was defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.
  • Complete Response Rate
    Complete response rate was defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.
  • Progression-Free Survival
    Progression-free survival (PFS) was defined as the interval from first dose of study drug to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an IRC.
  • Overall Survival
    Overall survival was defined as the interval from the start of study treatment to death from any cause.
  • Minimal Residual Disease Negativity Rate at Week 36
    Minimal residual disease (MRD) negativity rate was defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation. For participants receiving the final dose of rituximab after the original scheduled date, the MRD assessment will be performed no fewer than 12 weeks after the last dose of rituximab.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2014)
  • Duration of Response [ Time Frame: Up to 10 years ]
    Duration of response (DOR) is defined as the interval from the first documentation of CR or PR to the first documentation of definitive disease progression or death from any cause.
  • Complete Response Rate [ Time Frame: Up to 10 years ]
    Complete response (CR) rate is defined as the proportion of participants who achieve a CR
  • Progression-Free Survival [ Time Frame: Up to 10 years ]
    Progression-free survival (PFS) is defined as the interval from the first dose of study drug to the first documentation of definitive disease progression or death from any cause.
  • Minimal residual disease negativity rate [ Time Frame: Up to 10 years ]
    Minimal residual disease (MRD) negativity rate is defined as the proportion of participants with MRD <10^-4, as assessed by flow cytometry in bone marrow at Week 36 after therapy initiation.
  • Nodal Response Rate [ Time Frame: Up to 10 years ]
    Nodal response rate is defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lesions.
  • Overall Survival [ Time Frame: Up to 10 years ]
    Overall survival (OS) is defined as the interval from the start of study treatment to death from any cause.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Idelalisib in Combination With Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia With 17p Deletion
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE B-cell Chronic Lymphocytic Leukemia (CLL) With 17p Deletion
Intervention  ICMJE
  • Drug: Idelalisib
    150 mg tablets administered orally twice daily
    Other Names:
    • GS-1101
    • CAL-101
    • Zydelig®
  • Drug: Rituximab
    375 mg/m^2 administered intravenously once weekly x 8 weeks
    Other Name: Rituxan
Study Arms  ICMJE Experimental: Idelalisib + rituximab
Participants will receive rituximab for 8 weeks and Idelalisib continuously throughout the study (up to 10 years).
Interventions:
  • Drug: Idelalisib
  • Drug: Rituximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 15, 2016)
102
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2014)
100
Actual Study Completion Date  ICMJE May 17, 2016
Actual Primary Completion Date April 27, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key 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 fluorescence in-situ hybridization (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

Key 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Czechia,   Denmark,   France,   Hungary,   Italy,   Poland,   Portugal,   Romania,   Spain,   United Kingdom,   United States
Removed Location Countries Canada,   Czech Republic,   Switzerland
 
Administrative Information
NCT Number  ICMJE NCT02044822
Other Study ID Numbers  ICMJE GS-US-312-0133
2013-003314-41 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP