Sequential Treatment With RO-MTX After Pomalidomide, Orelabrutinib, Rituximab (POR) in Newly-diagnosed PCNSL

NCT05390749 | Recruiting Phase 2

• 1 other identifier: PUMCH-NHL-013
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of sequential treatment regimens with RO-MTX after pomalidomide, orelabrutinib, rituximab (POR) in newly-diagnosed primary central nervous system lymphoma, and explore the feasibility of chemo-free treatment in PCNSL. The primary objective was the overall response rate (ORR; defined as partial response \[PR\] or better) after 4 cycles of POR.

Conditions

Primary Central Nervous System Lymphoma

Keywords

Orelabrutinib; Pomalidomide; Rituximab; primary central nervous system lymphoma; methotrexate

Outcome Measures

Primary Outcomes (1)

• overall response rate

  ORR is defined as the proportion of patients with a best response of CR, CRu or PR

  The ORR will be evaluated at 82 days from the POR treatment, which means after 4 cycles and each cycle is 21 days

Secondary Outcomes (5)

• overall response rate

  The ORR will be evaluated at 126 days from date of signing the informed consent , which means after 6 cycles and each cycle is 21 days

• complete response rate

  The ORR will be evaluated at 82 days from the POR treatment, which means after 4 cycles and each cycle is 21 days

• 2 years progression-free survival

  From date of signing the informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

• 2 years overall survival

  From date of signing the informed consent until the date of death from any cause, whichever came first, assessed up to 2 years

• The occurrence of adverse events and serious adverse events

  during follow-up, up to 2 years

Study Arms (1)

POR-ROMTX

EXPERIMENTAL

The experimental arm will be treated with 4 cycles of POR regimen （Pomalidomide 4mg d1-d14, Orelabrutinib 150mg d1-d21, Rituximab 375mg/m2 d1, 21 days per cycle). The response will be evaluated every 2 cycles. The patients with PD will drop out of the study.Patients with CR/PR/SD after 4 cycles of POR treatment will be treated with 2 cycles of RO-MTX regimen（methotrexate 3.5g/m2 civ d1, Orelabrutinib 150mg d1-d21, Rituximab 375mg/m2 d1, 21 days per cycle).

Drug: Orelabrutinib; Drug: Pomalidomide; Drug: Rituximab; Drug: Methotrexate

Interventions

Orelabrutinib DRUG

Orelabrutinib will be given as 150mg orally d1-d21 for 6 cycles,every 21 days for 1 cycle.

POR-ROMTX

Pomalidomide DRUG

Pomalidomide will be given as 4mg d1-d14 for 4 cycles,every 21 days for 1 cycle.

POR-ROMTX

Rituximab DRUG

Rituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 6 cycles will be prescribed as protocol

POR-ROMTX

Methotrexate DRUG

methotrexate 3.5g/m2 civ d1/cycle5-6

POR-ROMTX

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed primary central nervous system lymphoma
• Pathological type is B cell lymphoma
• Age 18-70 years
• Demonstrate adequate marrow hemopoietic function as defined below:WBC\>3.0×109/L,ANC\>1.5×109/L,HGB\>90g/L,PLT\>80×109/L
• Demonstrate adequate organ function as defined below: cardiac function grade 0-2（NYHA）；SpO2\>88%( natural state)；ALT\<3UNL，TBil\<2ULN; SCr\>60ml/min/m2
• Having at least one measurable lesions
• Sign the Informed consent

You may not qualify if:

• The pathological diagnosis was T-cell lymphoma.
• systemic lymphoma involved CNS
• Pre-existing uncontrolled active infection
• Acute myocardial infarction or unstable angina within 6 months; Uncontrolled hypertension and arrhythmia
• Active bleeding
• Allergic to any component of the investigational product.
• Subjects who are suspected to be unable to comply with the study protocol
• Pregnancy or active lactation

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Beijing Tiantan Hospital: collaborator
• Capital Medical University: collaborator

Study Sites (3)

Beijing TianTan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

Sanbo Brain Hospital Capital Medical University

Beijing, Beijing Municipality, 100500, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Interventions

orelabrutinib; pomalidomide; Rituximab; Methotrexate

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Yan Zhang, M.D.

CONTACT

+8613810000485; zhangyan10659@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 25, 2022
• Study Start: April 11, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2026
• Last Updated: May 25, 2022

Record last verified: 2022-04

Locations

CN (3)