Substudy-1: Chronic lymphocytic leukaemia, Small lymphocytic lymphoma Substudy-2: Mantle cell lymphoma Substudy-3: Large B-cell lymphoma
Conditions
Interventions
Substudy-1:
In Cohort 1A, Participants will receive AZD0486 monotherapy as subcutaneous (SC) injection.
In Cohort 1B, Participants will receive AZD0486 as SC injection. Participants will receive acala
Sponsors
Hibi Kazushige
Eligibility
Inclusion criteria
Inclusion criteria: Master Inclusion Criteria applicable to all substudies: -Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. -Contraception use during treatment and at least 90 days after final dose. -Confirmed CD19 expression if prior anti-CD19 therapy. Substudy 1 Specific Inclusion Criteria: -Participants with CLL must require treatment according to the international workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. -SLL: at least 1 measurable site per Lugano. -Absolute lymphocytes 50%. -Contraception at least 90 days after last dose of AZD0486 or 4 months after last dose of vincristine, and 6 months after the last dose of cyclophosphamide, or doxorubicin.
Exclusion criteria
Exclusion criteria: Master Exclusion Criteria applicable to all substudies -Central nervous system (CNS) lymphoma. -Surgery within 14 days of study drug. -Clinically significant cardiovascular (CV) disease. -Unresolved Grade >2 AEs from prior anticancer therapy (except alopecia or fatigue). -Any anticancer therapy within 5 half-lives or 21 days (whichever is shorter) prior to treatment. -Radiation therapy within 28 days. -Prior CAR-T cell therapy or autologous-haematopoietic stem cell transplant (HSCT) within 12 weeks or prior T-cell engager (TCE) within 8 weeks. -Prior Grade > 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) event. -Prior allogeneic HSCT or solid organ transplantation within 24 weeks of starting Cycle 1 Day 1. Substudy 1 Specific Exclusion Criteria -CLL transformation to more aggressive lymphoma -Cohort 1B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or stroke within 24 weeks, GI malabsorption, receiving vitamin K antagonist Substudy 3 Specific Exclusion Criteria -Mediastinal grey-zone lymphoma, Burkitt, Richter's transformation, primary effusion large B-cell lymphoma (LBCL) -Cumulative dose of anthracycline >150 mg/m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Number of Participants with Adverse Events, Serious Adverse Events and Adverse Events of Special Interest - Number of Participants with Dose Limiting Toxicity (DLTs) | — |
Countries
Australia, China, Czech Republic, Denmark, France, Germany, Japan, South Korea, Spain, Taiwan, United Kingdom, United States of America
Contacts
Public ContactKazushige Hibi
Astrazeneka K.K
Outcome results
None listed