A Study of OLR in First-line Treatment of Mantle Cell Lymphoma

• Status: Recruiting
• Trial end date: 2023-10-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-arm, multicenter, open label phase II clinical study to evaluate the efficacy and safety of OLR in the treatment of initially treated mantle cell lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Treatments: Lenalidomide; Rituximab

Criteria

Inclusion Criteria:

1. Histopathologically confirmed mantle cell lymphoma with chromosomal translocation. All subjects must provide adequate archived or fresh tumor tissue samples for immunohistochemistry (IHC) testing.

2. Age 18-70, both male and female.

3. No previous systemic treatment for lymphoma.

4. Have at least one measurable lesion. Measurable disease was defined as measurable tumor masses ≥1.5 cm in one or both dimensions and measurable spleen lesions.

5. Eastern Oncology Collaboration group physical status score was 0-2.

6. Adequate hematological function

7. Life expectancy >3 months.

8. Have the ability to provide written informed consent and understand and comply with study requirements.

9. Ability to adhere to research visit schedules and other protocol requirements

Exclusion Criteria:

1. Histology conformed blastolytic mantle cell lymphoma and polymorphic mantle cell lymphoma.

2. Patients with current or suspected central nervous system involvement and history of this disease

3. Received Bruton's tyrosine kinase inhibitor treatment

4. Receive lenalidomide treatment

5. Received other anti-tumor treatments

6. Major surgery within 4 weeks prior to screening.

7. Have a history of other active malignant diseases within 2 years prior to study entry,

8. Systemic fungal, bacterial or viral infection with uncontrolled activity

9. The following serological states are known for human immunodeficiency virus (HIV) infection or suggest the presence of active hepatitis B or C virus infection

10. Clinically serious cardiovascular disease

11. A history of severe hemorrhagic disorders, such as hemophilia A, hemophilia B, von willebrand disease, or A history of spontaneous bleeding requiring blood transfusion or other medical intervention.

12. A history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months.

13. A history of major cerebrovascular disease/event, including stroke or intracranial hemorrhage, in the 6 months prior to first administration of the study drug.

14. Anticoagulant therapy with warfarin or an equivalent vitamin K antagonist or anticoagulant therapy is required within 7 days of initial use of the study drug.

15. Pregnant or lactating women

16. Hypersensitivity to any study drug

17. The presence of any life-threatening disease, medical condition, or organ system dysfunction that the investigator considers to be likely to affect the safety of the subject or cause risk