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ACTIVE NOT RECRUITING
NCT06547944
PHASE1

Zanubrutinib, Obinutuzumab and Lenalidomide in Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

Summary

The ZGR regimen limited-course regimen was designed to combine three targeted agents, zanubrutinib, obinutuzumab (a third-generation CD20 monoclonal antibody), and lenalidomide, to deepen the depth of remission in patients with new-diagnosis CLL/SLL, with a view to achieving the goal of discontinuation of the drug and long-term remission after discontinuation of the drug, and prolonging the PFS, and at the same time, the regimen no longer includes cytotoxic chemotherapeutic agents, such as fludarabine and cyclophosphamide, which improves the CLL/ SLL patients' treatment tolerance, and can eliminate the treatment limitation for elderly or poorly tolerated CLL/SLL patients.

Official title: A Phase 1b Clinical Study of Lenalidomide in Combination With Zanubrutinib and Obinutuzumab (ZGR) in the Treatment of Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) With Therapeutic Indications

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-01-01

Completion Date

2026-12-01

Last Updated

2024-08-09

Healthy Volunteers

No

Interventions

DRUG

Zanubrutinib

160mg bid/d, from C1 to CR and MRD-negative or C24

DRUG

Lenalidomide

From C3 dose escalation, all 3 dose groups climbed from 5 mg/d to 10 mg/d, 15 mg/d, and 20 mg/d respectively, Taking 21 days of medication and 7 days of rest, 1 cycle every 28 days to CR and MRD-negative or C24

DRUG

Obinutuzumab

1000 mg C1, d1/d8/15; 1000 mg C2-6, d1

Locations (1)

Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College

Tianjin, Tianjin Municipality, China