Study of Capivasertib in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma - CAPITAL

Exclusion Criteria

• - Prior malignancy (other than the disease under study), except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which the participant has been disease free for ≥ 2 years
• - With the exception of alopecia, any unresolved non-haematological toxicities from prior therapy ≥ Common Terminology Criteria for Adverse Events Grade 2 at the time of starting study treatment
• - Known medically apparent central nervous system lymphoma or leptomeningeal disease
• - Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values at screening:
• a) Absolute neutrophil count < 1.0 × 10^9/L; < 0.75 × 10^9/L in participants with known bone marrow involvement of malignant disease
• b) Platelets < 75 × 10^9/L; < 50 × 10^9/L in participants with known bone marrow involvement of malignant disease
• c) Creatinine clearance < 50 mL/min per the Cockcroft and Gault formula
• - Clinically significant abnormalities of glucose metabolism as participants with diabetes mellitus type I or diabetes mellitus type II requiring insulin treatment and Glycosylated haemoglobin ≥ 8.0% (63.9 mmol/mol)
• - Prior treatment with any of the following:
• a) Any investigational agents or study drugs from a previous clinical study within 5 half lives or 2 weeks from the first dose of capivasertib in this study
• b) Strong inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John’s wort), or drugs that are sensitive to inhibition of CYP3A4 within 1 week prior to the first dose of study treatment
• c) Prior allogenic Haematopoietic stem cell transplant (HSCT) within 6 months from the first dose of capivasertib (patients > 6 months after allogenic HSCT are eligible in the absence of active graft-versus-host disease and concomitant immune suppressive therapy). Prior cellular therapies (eg, Chimeric antigen receptor T therapy) and/or autologous HSCT within 3 months from the first dose of capivasertib
• d) Receipt of live, attenuated vaccine within 28 days before the first dose of study treatment(s)
• e) Participants who, due to other medical conditions /prior history /concomitant medications are, in the investigator's opinion, at a risk of a venous thromboembolism (VTE) and are not willing to accept the VTE prophylaxis, will be excluded. The initiation of an adequate VTE prophylaxis will be based on treating physician risk/benefit assessment and in agreement with the local management guidelines
• Additional exclusion core criteria may apply, please refer to the protocol
• Module 1 specific exclusion criteria:
• 1. Follicular lymphoma grade 3B
• 2. Known transformation to aggressive lymphoma, eg, large cell lymphoma
• 3. Participants who, in the Investigator’s opinion, require immediate cytoreductive therapy for disease control