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

Primary Purpose

Mantle Cell Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Orelabrutinib in in combination of rituximab and lenalidomide(OLR)
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tianjin Medical University Cancer Insititute & HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Orelabtutinib in combination of rituximab and lenalidomide(OLR) Arm

Arm Description

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

Outcomes

Primary Outcome Measures

Complete Response Rate
The proportion of patients receiving the treatment with complete remission

Secondary Outcome Measures

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

Full Information

First Posted
September 30, 2021
Last Updated
November 3, 2021
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05076097
Brief Title
A Study of OLR in First-line Treatment of Mantle Cell Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
October 15, 2022 (Anticipated)
Study Completion Date
October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Orelabtutinib in combination of rituximab and lenalidomide(OLR) Arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Orelabrutinib in in combination of rituximab and lenalidomide(OLR)
Other Intervention Name(s)
OLR Arm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complete Response Rate
Description
The proportion of patients receiving the treatment with complete remission
Time Frame
At the end of Cycle 6(each cycle is 28 days)
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
The proportion of patients with response of PR and CR.
Time Frame
Approximately 2 years
Title
Time to Response
Description
Measured from the date of initiation of treatment to the time of response
Time Frame
Approximately 1 year
Title
The Progression Free Survival Rate in 2 Years
Description
The proportion of patients who didn't achieve disease progression or death in 2 years.
Time Frame
2 Years
Title
The Overall Survival Rate in 2 Years
Description
The proportion of patients who didn't achieve death in 2 years
Time Frame
2 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histopathologically confirmed mantle cell lymphoma with chromosomal translocation. All subjects must provide adequate archived or fresh tumor tissue samples for immunohistochemistry (IHC) testing. Age 18-70, both male and female. No previous systemic treatment for lymphoma. 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. Eastern Oncology Collaboration group physical status score was 0-2. Adequate hematological function Life expectancy >3 months. Have the ability to provide written informed consent and understand and comply with study requirements. Ability to adhere to research visit schedules and other protocol requirements Exclusion Criteria: Histology conformed blastolytic mantle cell lymphoma and polymorphic mantle cell lymphoma. Patients with current or suspected central nervous system involvement and history of this disease Received Bruton's tyrosine kinase inhibitor treatment Receive lenalidomide treatment Received other anti-tumor treatments Major surgery within 4 weeks prior to screening. Have a history of other active malignant diseases within 2 years prior to study entry, Systemic fungal, bacterial or viral infection with uncontrolled activity The following serological states are known for human immunodeficiency virus (HIV) infection or suggest the presence of active hepatitis B or C virus infection Clinically serious cardiovascular disease 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. A history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months. A history of major cerebrovascular disease/event, including stroke or intracranial hemorrhage, in the 6 months prior to first administration of the study drug. 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. Pregnant or lactating women Hypersensitivity to any study drug 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huilai Zhang, PHD
Phone
18622221228
Email
18526812877@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Fei, Master
Phone
15865928897
Email
feiyue@tmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huilai Zhang, PHD
Organizational Affiliation
Director of Hematology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University Cancer Insititute & Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300181
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huilai Zhang, PHD
Phone
18622221228
Email
18526812877@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual patient data will be shared with other researchers
Citations:
Citation
2020 ASH, poster 2042
Results Reference
background
Citation
EHA 2020-Abstract S228
Results Reference
background
PubMed Identifier
26096944
Citation
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 Sep;90(9):790-5. doi: 10.1002/ajh.24086. Epub 2015 Jul 27.
Results Reference
result

Learn more about this trial

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

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