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Completed

NCT Number: NCT03582098

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

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

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Key information

Conditions

Chronic Lymphocytic Leukaemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St James Hospital, Dublin, Ireland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

idelalisib

Drug

Tablets were administered in accordance with the marketing authorization.

Other names: Zydelig®

Rituximab

Drug

Tablets were administered in accordance with the marketing authorization.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Starting Dose of Idelalisib

    Time frame: Up to 3 months

  7. Proportion of Participants with Dose-Modifications, Treatment Interruptions and Discontinuations of Idelalisib

    Time frame: Up to 3 months

  8. Proportion of Participants For Whom antibiotic Prophylactic Measures were Effective

    Time frame: Up to 3 months

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Acronym: RETRO-idel

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 10, 2018
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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