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

NCT05076097 | Unknown Phase 2

• 1 other identifier: TS024
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Objective Response Rate

  Approximately 2 years

• Time to Response

  Approximately 1 year

• The Progression Free Survival Rate in 2 Years

  2 Years

• The Overall Survival Rate in 2 Years

  2 Years

Study Arms (1)

Orelabtutinib in combination of rituximab and lenalidomide(OLR) Arm

EXPERIMENTAL

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

Drug: Orelabrutinib in in combination of rituximab and lenalidomide(OLR)

Interventions

Orelabrutinib in in combination of rituximab and lenalidomide(OLR) DRUG

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.

Also known as: OLR Arm

Orelabtutinib in combination of rituximab and lenalidomide(OLR) Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Insititute & Hospital

Tianjin, Tianjin Municipality, 300181, China

RECRUITING

Related Publications (3)

• 2020 ASH, poster 2042

  BACKGROUND

• EHA 2020-Abstract S228

  BACKGROUND

• 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.

  PMID: 26096944 RESULT

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

orelabrutinib; Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Huilai Zhang, PHD

  Director of Hematology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huilai Zhang, PHD

CONTACT

18622221228; 18526812877@163.com

Yue Fei, Master

CONTACT

15865928897; feiyue@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 13, 2021
• Study Start: September 30, 2021
• Primary Completion: October 15, 2022
• Study Completion: October 15, 2023
• Last Updated: November 11, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)