Study of Ibrutinib + CD20 Antibody and Venetoclax in Patients With Untreated Mantle Cell Lymphoma
Study of Ibrutinib + CD20 Antibody and Venetoclax in Patients With Untreated Mantle Cell Lymphoma
ClinicalTrials.gov ID: NCT04802590
Sponsor: The Lymphoma Academic Research Organisation
Information provided by: The Lymphoma Academic Research Organisation (Responsible Party)
Last Update Posted: 2023-03-17
Brief Summary:
The OASIS II trial is a multicentre, open label, randomized phase II trial. We will compare the efficacy of Ibrutinib/anti-CD20 Ab versus Ibrutinib/anti-CD20 Ab/Venetoclax given as fixed duration combinations in newly diagnosed Mantle Cell Lymphoma (MCL) patients (≥ 18 years and < 80 years of age).
Treatment duration of Ibrutinib and Venetoclax will be a maximum of two years. Patients will be treated with CD20 Ab for 3.5 years.
The primary aim is to assess MRD status at 6 months in both arms.
Official Title:
A Randomized Phase II Trial Evaluating Ibrutinib Plus CD20 Ab and Venetoclax in Patients With Untreated Mantle Cell Lymphoma
Intervention / Treatment:
- Drug: Ibrutinib 560 mg
- Drug: Venetoclax 10 MG Oral Tablet [Venclexta]
- Drug: Venetoclax 50 MG Oral Tablet [Venclexta]
- Drug: Venetoclax 100 MG Oral Tablet [Venclexta]
| Category | Value |
|---|---|
| Study Start (Actual) |
2022-01-24
|
| Primary Completion (Estimated) |
2026-03-31
|
| Study Completion (Estimated) |
2031-09-30
|
| Enrollment (Estimated) | 194 |
| Study Type | Interventional |
| Phase | Phase 2 |
| Other Study ID Numbers |
OASIS-II
|