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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04094051
• Other study ID #: JNJ-54179060
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2019
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Jianyong Li, Ph.D.
• Phone: 025-83718836
• Email: lijianyonglm[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 580
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Small Lymphocytic Lymphoma

Intervention

Drug:
• Ibrutinib
In the retrospective period, clinical information of approximate 500 patients with CLL/SLL prior to the study initiation will be collected retrospectively through chart review. There will be one time follow-up to collect data on disease progression, survival status and patient-reported outcomes.

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University	Xian-Janssen Pharmaceutical Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Treatment response	PFS, ORR, OS, minimal residual disease(MRD), patient-reported outcomes	Up to 10 years