Observational study to describe disease characteristics, treatment patterns, treatment-related outcomes for Chronic Lymphocytic Leukemia (CLL) patients.

Completed

• Conditions: Lymphoid leukemia, unspecified,

• Registration Number: CTRI/2021/11/038192
• Lead Sponsor: AstraZeneca Pharma India Ltd

Brief Summary

This is a retrospective, observational, registry-based study including patients with a diagnosis of CLL and started treatment (1st line, 2nd line, or Subsequent lines of treatment) data for a given patient will be collected during a one-time summary of medical records and will include at least one year of the patient’s data.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-12
• Study Completion: 2024-01-31
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1250

Inclusion Criteria

• Primary diagnosis of Chronic Lymphocytic Leukemia (CLL) 2.
• Initiated CLL treatment (including 1st line 2nd line or Subsequent lines of treatment) within the period between 01 June 2016 and 12 months before data collection For GCC pilot cohort patients: treatment naive CLL patients diagnosed between 01 June 2016, and 12 months before data collection 3.
• Available medical records at the participating site reflecting at least 12 months of follow-up after starting on treatment (except in the case of the participant death within one year following treatment initiation) 4.
• Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at study entry unless a waiver was granted) according to local regulations 5.
• Adult male or female ≥18 years old at the time of diagnosis or according to the age of majority as defined by local regulations).

Exclusion Criteria

• Failure to meet one or more of the inclusion criteria.
• Any diagnosis of B cell malignancies other than CLL.
• Current or prior use of acalabrutinib treatment.
• Currently previously receiving treatment in an interventional clinical trial at the time of entry into this study for indications CLL.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(1) Recording patient characteristics.	one-time
(2) Recording disease characteristics.	one-time

Secondary Outcome Measures

Name	Time	Method
(1) Recording the treatment patterns. (2) Recording the treatment-related outcomes.	one-time

Trial Locations

Locations (10)

Asian Institute of Medical Sciences; 🇮🇳 Faridabad, HARYANA, India

Dr. BL Kapur Memorial Hospital; 🇮🇳 Delhi, DELHI, India

Fortis Memorial Research Institute; 🇮🇳 Gurgaon, HARYANA, India

Hemato Oncology Clinic Vedanta Institute of Medical Sciences; 🇮🇳 Ahmadabad, GUJARAT, India

Manipal Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Max Super Speciality Hospital; 🇮🇳 Delhi, DELHI, India

Narayana Super Speciality Hospital; 🇮🇳 Haora, WEST BENGAL, India

Sher-I-Kashmir Institute of Medical Sciences; 🇮🇳 JAMMU, & KASHMIR, India

Tata Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Yashoda Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Asian Institute of Medical Sciences

🇮🇳Faridabad, HARYANA, India

Dr Prashant Mehta

Principal investigator

9599460474

prashantcipher7@gmail.com