A Phase I/II Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination with Other Anticancer Agents in Participants with Mature B-Cell Malignancies Substudy 1: Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma Substudy 2: Mantle Cell Lymphoma Substudy 3: Large B-Cell Lymphoma

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515034-33-00

Acronym

D7407C00001

Enrollment

200

Registered

2025-01-07

Start date

2025-03-05

Completion date

Unknown

Last updated

2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mantle Cell Lymphoma, Large B-Cell Lymphoma, Chronic Lymphocytic Leukaemia, Small Lymphocytic Lymphoma

Brief summary

Incidence, nature and severity of AEs/SAEs based on NCI CTCAE v5.0/ASTCT criteria; changes in laboratory data, and vital signs compared with baseline, Incidence of Dose Limiting Toxicity (DLTs), Incidence and severity of AESIs, Incidence and nature of study drug discontinuation, dose reduction and dose delay due to AEs

Interventions

DRUGRITUXIMAB

DRUGCYCLOPHOSPHAMIDE

DRUGAZD0486

DRUGPREDNISOLONE

DRUGVINCRISTINE

DRUGCalquence 100 mg film-coated tablets

DRUGDOXORUBICIN

DRUGPREDNISONE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence, nature and severity of AEs/SAEs based on NCI CTCAE v5.0/ASTCT criteria; changes in laboratory data, and vital signs compared with baseline, Incidence of Dose Limiting Toxicity (DLTs), Incidence and severity of AESIs, Incidence and nature of study drug discontinuation, dose reduction and dose delay due to AEs	—

Countries

Czechia, Denmark, France, Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026