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Clinical Outcomes and Routine Management of Adults With Chronic Lymphocytic Leukaemia Treated With Idelalisib and Rituximab in the United Kingdom (UK) and Ireland (RETRO-idel)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03582098
Recruitment Status : Completed
First Posted : July 10, 2018
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date June 27, 2018
First Posted Date July 10, 2018
Last Update Posted Date April 12, 2019
Actual Study Start Date September 12, 2018
Actual Primary Completion Date March 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 27, 2018)
Overall Response Rate [ Time Frame: Up to 3 months ]
Overall Response Rate (ORR) is defined as the proportion of participants who achieve a clinical response as documented within their patient records after the initiation of treatment with idelalisib and rituximab during the observation period.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03582098 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 27, 2018)
  • Overall Survival [ Time Frame: Up to 3 months ]
    Overall survival (OS) is defined as the interval from the initiation of idelalisib and rituximab to death from any cause
  • Progression-Free Survival [ Time Frame: Up to 3 months ]
    Progression-free survival (PFS) is defined as the interval from the initiation of idelalisib and rituximab to the first documentation of definitive disease progression or death from any cause; definitive disease progression is CLL progression based on documentation in participant records
  • Time to Next Treatment [ Time Frame: Up to 3 months ]
    Time to next treatment (TTNT) is defined as the interval from the initiation of treatment with idelalisib and rituximab to the initiation of next treatment
  • Duration of Response [ Time Frame: Up to 3 months ]
    Duration of response (DOR) is defined as the interval from the first documentation of clinical response to the earlier of the first documentation of definitive disease progression or death from any cause
  • Overall Safety and Tolerability of Idelalisib and Rituximab as Measured by the Incidence of Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) [ Time Frame: Up to 3 months ]
  • Starting Dose of Idelalisib [ Time Frame: Up to 3 months ]
  • Proportion of Participants with Dose-Modifications, Treatment Interruptions and Discontinuations of Idelalisib [ Time Frame: Up to 3 months ]
  • Proportion of Participants For Whom antibiotic Prophylactic Measures were Effective [ Time Frame: Up to 3 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Outcomes and Routine Management of Adults With Chronic Lymphocytic Leukaemia Treated With Idelalisib and Rituximab in the United Kingdom (UK) and Ireland
Official Title A Retrospective Observational Study to Evaluate the Clinical Outcomes and Routine Management of Patients With Chronic Lymphocytic Leukaemia Treated With Idelalisib and Rituximab in the United Kingdom (UK) and Ireland
Brief Summary The primary objective of this study is to evaluate the effectiveness of idelalisib and rituximab in adults with chronic lymphocytic leukaemia (CLL) in a real world setting
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Potential study participants will be identified by sites/hospitals as eligible for inclusion in the study by review of hospital records, including prescribing databases and by members of their direct care team and/or site personnel. The study will only include individuals who initiated idelalisib from September 2014, the date of marketing authorisation, up to and inclusive of 31 December 2017.
Condition Chronic Lymphocytic Leukaemia
Intervention
  • Drug: Idelalisib
    Tablets were administered in accordance with the marketing authorization.
    Other Name: Zydelig®
  • Drug: Rituximab
    Tablets were administered in accordance with the marketing authorization.
Study Groups/Cohorts Idelalisib and Rituximab
Individuals who received treatment for CLL with at least one dose of idelalisib and rituximab in accordance with the marketing authorisation.
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 Completed
Actual Enrollment
 (submitted: April 11, 2019)
112
Original Estimated Enrollment
 (submitted: June 27, 2018)
150
Actual Study Completion Date March 26, 2019
Actual Primary Completion Date March 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of CLL documented within medical records
  • Individuals who have received treatment for CLL with at least one dose of idelalisib and rituximab in accordance with the marketing authorisation at the time of starting idelalisib treatment
  • Idelalisib and rituximab initiated on or before 31 December 2017

Exclusion Criteria:

  • Individuals who received idelalisib as part of an interventional clinical trial
  • Individuals who received idelalisib for other indications including follicular lymphoma (FL)
  • Individuals who previously received idelalisib in combination with ofatumumab
  • Use of idelalisib which is not in accordance with its marketing authorisation at the time of starting idelalisib treatment
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Ireland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03582098
Other Study ID Numbers GS-UK-312-4639
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Gilead Sciences
Study Sponsor Gilead Sciences
Collaborators Not Provided
Investigators
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date April 2019