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

• Conditions: Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia

• Registration Number: NCT04094051
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-15
• Study First Submitted QC: 2019-09-16
• Last Update Submitted: 2019-09-16
• Study First Posted: 2019-09-18
• Last Update Posted: 2019-09-18
• Study Start: 2019-10-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 580

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient and disease characteristics	Up to 10 years	age, gender, Eastern Cooperative Oncology Group (ECOG), stage, Bulky disease, Cytogenetics, median ANC, median hemoglobin, median platelets, comorbidity.
Treatment pattern	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Treatment response	Up to 10 years	PFS, ORR, OS, minimal residual disease(MRD), patient-reported outcomes

Trial Locations

Locations (1)

the First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China