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

Sponsor
Tianjin Medical University Cancer Institute and Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05076097
Collaborator
(none)
29
Enrollment
1
Location
1
Arm
24.5
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Orelabrutinib in in combination of rituximab and lenalidomide(OLR)
Phase 2

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
29 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 30, 2021
Anticipated Primary Completion Date :
Oct 15, 2022
Anticipated Study Completion Date :
Oct 15, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Orelatinib 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

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.
Other Names:
  • OLR Arm
  • Outcome Measures

    Primary Outcome Measures

    1. Complete response rate [6 cycles,24weeks]

      The proportion of patients receiving the treatment with complete remission

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Tianjin Medical University Cancer Insititute & HospitalTianjinTianjinChina300181

    Sponsors and Collaborators

    • Tianjin Medical University Cancer Institute and Hospital

    Investigators

    • Principal Investigator: Huilai Zhang, PHD, Director of Hematology Department

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Tianjin Medical University Cancer Institute and Hospital
    ClinicalTrials.gov Identifier:
    NCT05076097
    Other Study ID Numbers:
    • TS024
    First Posted:
    Oct 13, 2021
    Last Update Posted:
    Oct 13, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 13, 2021