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

  • STATUS
    Recruiting
  • End date
    Oct 15, 2023
  • participants needed
    29
  • sponsor
    Tianjin Medical University Cancer Institute and Hospital
Updated on 19 November 2021
rituximab
measurable disease
lenalidomide
mantle cell lymphoma

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.

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

Details
Condition Lymphoma, Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma, Mantle cell lymphoma
Treatment Orelabrutinib in in combination of rituximab and lenalidomide(OLR)
Clinical Study IdentifierNCT05076097
SponsorTianjin Medical University Cancer Institute and Hospital
Last Modified on19 November 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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