Clinical trial · Interventional
A Study of OLR in First-line Treatment of Mantle Cell Lymphoma
A Prospective Phase II Clinical Study of Orelabrutinib in Combination With Lenalidomide and Rituximab (OLR) in First-line Treatment of Mantle Cell Lymphoma
NCT05076097CI-TRIAL-00054997unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Orelabrutinib in in combination of rituximab and lenalidomide(OLR) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Orelabtutinib in combination of rituximab and lenalidomide(OLR) 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
- interventionNames
- Drug: Orelabrutinib in in combination of rituximab and lenalidomide(OLR)
Primary outcomes (1)
- measure
- Complete Response Rate
- timeFrame
- At the end of Cycle 6(each cycle is 28 days)
- description
- The proportion of patients receiving the treatment with complete remission
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUND2020 ASH, poster 2042
- BACKGROUNDEHA 2020-Abstract S228
- RESULTAl-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