Health Condition 1: D728- Other specified disorders of whiteblood cells
Conditions
Interventions
Intervention1: Zanubrutinib: Dosage Form: Capsule
Dosage and Administration: 160 mg taken orally twice daily or 320 mg taken orally once
daily. Treatment Duration-18 months.
Control Intervention1: N
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged greater than or equal to 18 years with confirmed diagnosis of either Mantle Cell Lymphoma (MCL) who have received at least one prior therapy or Waldenstrom s Macroglobulinemia (WM) or Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy or Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) or Follicular Lymphoma (FL) in combination with obinutuzumab who have received at least two prior systemic therapies. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 3. Willing to provide signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Primary or secondary central nervous system (CNS) lymphoma. 2. History of severe hypersensitivity reactions to similar class of drugs or any contraindication to the planned chemotherapy regimen. 3. Active infection including infections requiring oral or intravenous anti-microbials. 4. Any life-threatening illness, medical condition or organ system dysfunction which,in the investigators opinion, could compromise the participants safety, or put the study at risk. 5. Pregnant or lactating females. 6. Concurrent participation in another therapeutic clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety profile of patients with MCL, WM, MZL, CLL/SLL or FL in India treated with Zanubrutinib in terms of - 1. Number of patients with any drug related treatment emergent adverse events 2. Number of patients with any treatment emergent adverse events (TEAEs) 3. Number of patients with adverse event of special interest (AESI) which includes atrial fibrillation, hypertension, bleeding, major hemorrhage, infections 4. Number of patients with serious TRAE (STRAE) and TEAEs (STEAEs) 5. AEs/SAEs leading to discontinuation of Zanubrutinib Co- Primary: To evaluate the efficacy of patients with MCL, WM, MZL, CLL/SLL or FL in India treated with Zanubrutinib in terms of - 1. Overall Response Rate (ORR) is defined as the percentage of participants who had complete response (CR) or partial response (PR) by standard disease-specific response criteria.Timepoint: Time Frame: up to 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of patients with MCL, WM, MZL, CLL/SLL or FL in India treated with Zanubrutinib in terms of - 1. Progression free survival (PFS) defined as the time from the date of enrolment to the date of first documentation of disease progression at 6 months, 12 months, and 18 months, as assessed by the investigator. 2.Overall Survival (OS) defined as the time from the date of enrolment until the date of death due to any cause upto 18 months. 3. Overall Response Rate (ORR) at 6 months and 12 months 4. Duration of response (DoR) defined as the time from the first determination of an objective response until the first documentation of progression or death, whichever comes first. 5. Health-Related Quality of Life (HRQoL) as assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30). Timepoint: baseline, 3 months, 6 months, 9 months, 12 months, 15 months and 18 months. | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
Glenmark Pharmaceuticals Ltd.
Outcome results
None listed