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

Phase 2

• Conditions: Mantle Cell Lymphoma
• Interventions: Drug: Orelabrutinib in in combination of rituximab and lenalidomide(OLR)

• Registration Number: NCT05076097
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief 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.

Detailed Description

Patients initially treated with mantle cell lymphoma were screened for OLR regimen according to study admission criteria. The study will accept up to 24 cycles of treatment until disease progression or intolerable toxicity occurs and subjects voluntarily withdraw informed consent. Patients undergoing hematopoietic stem cell transplantation after complete remission may begin stem cell collection after induction therapy for at least 6 months. Twenty-nine patients are expected to be enrolled

Study Timeline

• Status Verified: 2021-09
• Study Start: 2021-09-30
• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-10-12
• Study First Posted: 2021-10-13
• Last Update Submitted: 2021-11-03
• Last Update Posted: 2021-11-11
• Primary Completion: 2022-10-15
• Study Completion: 2023-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Orelabtutinib in combination of rituximab and lenalidomide(OLR) Arm	Orelabrutinib in in combination of rituximab and lenalidomide(OLR)	Induction phase of mantle cell L lymphoma: Orelabrutinib: 150mg QD D1-28; Lenalidomide: Cycle 1: 15mg QD D1-21, if no dose-limiting toxicity occurred in Cycle 1, cycle 2-6: 20mg QD D1-21; Cycle 1: 375 mg/m2 d1, 8,15,22; Cycle 3, 5: 375 mg/m2 D1 Maintenance treatment phase: Orelabrutinib: 150mg QD D1-28; Lenalidomide: cycle 7-24: 15mg QD D1-21; Cycle 7, 9, 11, 13, 15, 17, 19, 21, 23: 375 mg/m2 D1

Primary Outcome Measures

Name	Time	Method
Complete Response Rate	At the end of Cycle 6(each cycle is 28 days)	The proportion of patients receiving the treatment with complete remission

Secondary Outcome Measures

Name	Time	Method
The Overall Survival Rate in 2 Years	2 Years	The proportion of patients who didn't achieve death in 2 years
Objective Response Rate	Approximately 2 years	The proportion of patients with response of PR and CR.
The Progression Free Survival Rate in 2 Years	2 Years	The proportion of patients who didn't achieve disease progression or death in 2 years.
Time to Response	Approximately 1 year	Measured from the date of initiation of treatment to the time of response

Trial Locations

Locations (1)

Tianjin Medical University Cancer Insititute & Hospital; 🇨🇳 Tianjin, Tianjin, China