Clinical trial NCT05076097: A Study of OLR in First-line Treatment of Mantle Cell Lymphoma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Mantle Cell Lymphoma
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Complete Response Rate
timeFrame: At the end of Cycle 6(each cycle is 28 days)
Secondary outcomes:
measure: Objective Response Rate
timeFrame: Approximately 2 years
measure: Time to Response
timeFrame: Approximately 1 year
measure: The Progression Free Survival Rate in 2 Years
timeFrame: 2 Years
measure: The Overall Survival Rate in 2 Years
timeFrame: 2 Years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Insititute & Hospital
state: Tianjin
Study officials:
affiliation: Director of Hematology Department
name: Huilai Zhang, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 2020 ASH, poster 2042
citation: EHA 2020-Abstract S228
citation: 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.