Study identifier:D8220C00022
ClinicalTrials.gov identifier:NCT04930536
EudraCT identifier:N/A
CTIS identifier:N/A
A prospective, multi-centre, phase IV clinical trial to assess the safety and efficacy of Acalabrutinib capsules in Indian adult patients with chronic lymphocytic leukaemia and relapsed and refractory mantle cell lymphoma.
Chronic Lymphocytic Leukemia and relapsed and refractory mantle cell lymphoma
Phase 4
No
Acalabrutinib capsule
All
103
Interventional
18 Years - 99 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Oct 2024 by AstraZeneca
AstraZeneca
-
This study is plan to assess the safety and efficacy of Acalabrutinib in Indian patients with chronic lymphocytic leukaemia (CLL) and relapsed and refractory mantle cell lymphoma (MCL)
A prospective, multi-centre, phase IV clinical trial of Acalabrutinib capsules in Indian adult patients with chronic lymphocytic leukaemia (CLL) and relapsed and refractory mantle cell lymphoma (MCL). As per recommendation from Indian health authority, the current phase-IV study is planned with the aim to assess the safety and efficacy profile of Acalabrutinib in Indian patients with CLL/SLL, and patients with MCL who have received at least one prior therapy. The data obtained from the study will help to understand the safety and efficacy profile of Acalabrutinib in Indian patients. Patients will be monitored throughout the study period for Adverse Events of Acalabrutinib
Location
Location
Hyderabad, India, 500019
Location
Kochi, India, 682041
Location
Mumbai, India, 400010
Location
Guwahati, India, 781032
Location
Chandigarh, India, 160012
Location
Gurugram, India, 122001
Location
Kolkata, India, 700160
Location
Ahmedabad, India, 380009
Arms | Assigned Interventions |
---|---|
Experimental: Acalabrutinib Capsule Single-arm study | - |
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