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

Mantle Cell Lymphoma Clinical Trial

Official title:

A Prospective Phase II Clinical Study of Orelabrutinib in Combination With Lenalidomide and Rituximab (OLR) in First-line Treatment of Mantle Cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05076097
• Other study ID #: TS024
• Status: Recruiting
• Phase: Phase 2
• Start date: September 30, 2021
• Est. completion date: October 15, 2023

Study information

• Verified date: September 2021
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Huilai Zhang, PHD
• Phone: 18622221228
• Email: 18526812877[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: October 15, 2023
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

Drug:
• Orelabrutinib in in combination of rituximab and lenalidomide(OLR)
Induction treatment phase: 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. 28 days for a cycle.

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Insititute & Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

2020 ASH, poster 2042

Al-Hamadani M, Habermann TM, Cerhan JR, Macon WR, Maurer MJ, Go RS. Non-Hodgkin lymphoma subtype distribution, geodemographic patterns, and survival in the US: A longitudinal analysis of the National Cancer Data Base from 1998 to 2011. Am J Hematol. 2015 — View Citation

EHA 2020-Abstract S228

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response Rate	The proportion of patients receiving the treatment with complete remission	At the end of Cycle 6(each cycle is 28 days)
Secondary	Objective Response Rate	The proportion of patients with response of PR and CR.	Approximately 2 years
Secondary	Time to Response	Measured from the date of initiation of treatment to the time of response	Approximately 1 year
Secondary	The Progression Free Survival Rate in 2 Years	The proportion of patients who didn't achieve disease progression or death in 2 years.	2 Years
Secondary	The Overall Survival Rate in 2 Years	The proportion of patients who didn't achieve death in 2 years	2 Years