Observational Study of CLL/SLL Treatment and Ibrutinib Treatment of CLL/SLL in Routine Clinical Practice

A Retrospective and Prospective Observational Study of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Treatment and Ibrutinib Treatment of CLL/SLL in Routine Clinical Practice

This is a non-interventional, Phase 4 study designed to improve understanding of current clinical practice in the treatment of CLL/SLL and to describe treatment pattern and evaluate outcomes of ibrutinib-treated CLL patients in China. This study will include both retrospective and prospective data collection.

Study Overview

• Status: Unknown
• Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
• Intervention / Treatment: Drug: Ibrutinib

• Study Type: Observational
• Enrollment (Anticipated): 580

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Retrospective group: CLL/SLL patients who received CLL/SLL treatment before study initiation as judged by participating site physician. A telephone follow-up will be arranged at the time of study initiation to determine the disease progression, survival status, PRO assessments and ADR. If the patient is accessible, oral consent will be obtained and documented in the medical record before the retrospective data collection through chart review. If the patient is not accessible at the time of study initiation, ICF waiver approved by the IRB will be in place for the etrospective data collection according to the latest local regulation. Prospective group: CLL/SLL patients who are on ibrutinib treatment at the time of study initiation as judged by participating site physician or start ibrutinib treatment after study initiation. This group of patients can be divided into two subgroups.

Description

Inclusion Criteria:

• In the retrospective part:

  1. Male or female patients above 18 years old
  2. Patients underwent CLL treatment after Jan 1st, 2013
  3. Patient understand and voluntarily sign an ICF, if applicable.

• In the prospective part:

  1. Male or female patients above 18 years old
  2. Patients diagnosed with CLL，including treatment- naïve patients or patients who have received ≤3 prior therapies
  3. Patients treated with ibrutinib as monotherapy or a part of combination therapy
  4. Patient understand and voluntarily sign an ICF.

Exclusion Criteria:

• In the retrospective part:

  1. Patients with documented diagnosis of other cancers prior to the diagnosis of CLL
  2. Patients enrolled in interventional clinical trials of any drug for CLL treatment

• In the prospective part:

  1. Patients with documented diagnosis of other cancers prior to the diagnosis of CLL
  2. Patients with contraindication listed in the package insert of ibrutinib
  3. Patients enrolled in interventional clinical trials of ibrutinib or any other drug for CLL treatment
  4. Patient received Ibrutinib treatment as maintenance therapy.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient and disease characteristics	age, gender, Eastern Cooperative Oncology Group (ECOG), stage, Bulky disease, Cytogenetics, median ANC, median hemoglobin, median platelets, comorbidity.	Up to 10 years
Treatment pattern	number of prior therapies, every treatment regimen, dose, cycle/treatment duration, stem cell therapy (SCT), progression-free survival (PFS), overall survival (OS), patient-reported outcome.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment response	PFS, ORR, OS, minimal residual disease(MRD), patient-reported outcomes	Up to 10 years

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: Xian-Janssen Pharmaceutical Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2019
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: September 15, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (ACTUAL): September 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 16, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, B-Cell; Lymphoma; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid
• Other Study ID Numbers: JNJ-54179060

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No