A Study of OLR in First-line Treatment of Mantle Cell Lymphoma
NCT ID: NCT05076097
Last Updated: 2021-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
29 participants
INTERVENTIONAL
2021-09-30
2023-10-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Orelabtutinib in combination of rituximab and lenalidomide(OLR) Arm
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Huilai Zhang, PHD
Role: PRINCIPAL_INVESTIGATOR
Director of Hematology Department
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tianjin Medical University Cancer Insititute & Hospital
Tianjin, Tianjin Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Huilai Zhang, PHD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
2020 ASH, poster 2042
EHA 2020-Abstract S228
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TS024
Identifier Type: -
Identifier Source: org_study_id