Rituximab Plus Methotrexate With or Without Lenalidomide in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

NCT04481815 | Unknown Phase 2 FDA Drug

• 1 other identifier: IR2020001238
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

It is a multicenter, open-Label, randomised phase 2 study to compare the efficacy and safety study of R2-MTX chemotherapy（Lenalidomide, Rituximab and Methotrexate）with R-MTX chemotherapy（Rituximab and Methotrexate ）as first-line regimens in the treatment of newly diagnosed primary central nervous system lymphoma.2-year Progression free survival (PFS) is the primary endpoint.

Conditions

PCNSL

Keywords

PCNSL; Lenalidomide

Outcome Measures

Primary Outcomes (1)

• 2-year progression free survival

  From date of patients sign 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

Secondary Outcomes (4)

• Objective response rate

  At the end of Cycle 6 chemotheray

• Overall survival

  3 years

• Progression free survival

  3 years

• Treatment-related adverse events

  1 year

Other Outcomes (1)

• Serum ctDNA biomarkers and tissue biomarkers

  Up to 3 years

Study Arms (2)

R2-MTX

EXPERIMENTAL

Experimental arm will be treated with R2-MTX regimen(Lenalidomide plus Rituximab and Methotrexate) for 6 cycles as initiate induction.If the patients achieved complete remission（CR）or partial remission（PR）with additional whole-brain radiotherapy（WBRT）, they processed to R2 maintenance(Lenalidomide plus Rituximab) for 4 cycles.

Drug: Rituximab; Drug: Lenalidomide; Drug: Methotrexate

R-MTX

SHAM COMPARATOR

Control arm will be treated with R-MTX regimen(Rituximab and Methotrexate) for 6 cycles as initiate induction.If the patients achieved CR or PR with additional WBRT, they processed to Lenalidomide maintenance for 4 cycles.

Drug: Rituximab; Drug: Methotrexate

Interventions

Rituximab DRUG

375mg/m2 intravenous infusion d1, every 3 weeks for 1 cycle, 6 cycles will be prescribed for induction therapy. 375mg/m2 intravenous infusion d1, every 8 weeks for 1 cycle, 4 cycles will be prescribed for maintenance therapy.

R-MTX; R2-MTX

Lenalidomide DRUG

25mg orally d1-10 every 3 weeks for 1 cycle, 6 cycles will be prescribed for induction therapy. 25mg orally d1-14,d29-42 every 8 weeks for 1 cycle, 4 cycles will be prescribed for maintenance therapy.

R2-MTX

Methotrexate DRUG

3.5g/m2 intravenous infusion for 4 hours in d1, every 21 days for 1 cycle, 6 cycles will be prescribed.

R-MTX; R2-MTX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed Primary Central Nervous System (CNS) lymphoma
• Age range 18-75 years old.
• Eastern Cooperative Oncology Group performance status 0 to 3.
• Previously untreated. Patients treated with steroid alone are eligible.
• Patient's who are not planned to undergo consolidation with autologous hematopoietic stem cell transplantation（HSCT）.
• Measurable disease was defined as at least ≥1.0cm in short-diameter by MRI.
• Life expectancy of ≥ 3 months (in the opinion of the investigator).
• Participants must be able to understand and be willing to sign a written informed consent document.
• Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 6 months after the last dose of the study drug. Men who are sexually active must agree to use highly effective contraception during the period of therapy and for 6 months after the last dose.
• Women of childbearing potential must have a negative plasma pregnancy test upon study entry.
• Adequate renal function: Estimated glomerular filtration rate (GFR) or estimated creatinine clearance (CrCl) ≥ 50 mL/min;Serum creatinine ≤ 2 times the upper limit of normal.
• Adequate liver functions: Transaminase (AST/ALT) \< 3 X upper normal value \& Bilirubin \< 2 X upper normal value.
• Adequate hematological function: hemoglobin ≥ 9 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL.

You may not qualify if:

• Patient with systemic, non-CNS lymphoma metastatic to the CNS.
• Patient is concurrently using other approved or investigational antineoplastic agents.
• Presence of active hepatitis B virus(HBV) infection (HBsAg positive and HBV-DNA≥ 104), hepatitis C virus(HCV) infection, acquired and congenital immunodeficiency diseases include but not limited to HIV.
• Patient is allergic to components of the study drug.
• Patient has an active concurrent malignancy requiring active therapy.
• Patient has significant abnormalities on screening electrocardiogram (EKG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, uncontrolled congestive heart failure, uncontrolled hypertension, valvular disease, pericarditis, or myocardial infarction within 6 months of screening.
• Patient is known to have an uncontrolled active systemic infection.
• Patient has a life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety or put the study outcomes at undue risk.
• Women who are pregnant or nursing (lactating), where pregnancy is defined as a state of a female after conception until the termination of gestation, confirmed by a positive plasma human chorionic gonadotropin(hCG) laboratory test of \> 5 mIU/mL.
• The patient is unwell or unable to participate in all required study evaluations and procedures.
• Drug abuse, medical, psychological or social conditions which may interfering with subjects' participation in the study or evaluation of the results.
• Patients considered unsuitable to participate in the study by the researchers.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Interventions

Rituximab; Lenalidomide; Methotrexate

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Aminopterin; Pterins; Pteridines

Central Study Contacts

Xianggui Yuan, MD,PhD

CONTACT

+8613989883884; yuanxg@zju.edu.cn

Wenbin Qian, MD,PhD

CONTACT

+8613605801032; qianwb@zju.edu.cn

Study Design

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

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 22, 2020
• Study Start: October 1, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2025
• Last Updated: November 8, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)