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Rituximab, Lenalidomide Combined With Methotrexate and Temozolomide For Primary Central Nervous System Lymphoma

NCT04737889 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-04-23

No results posted yet for this study

Summary

This is a prospective single arm, multi-center, phase II clinical trial to observe the efficacy and safety of Rituximab, Lenalidomide combined with high-dose Methotrexate and Temozolomide (RL-MT) in the first-line treatment for patients with primary central nervous system lymphoma.

Conditions

Interventions

DRUG

Rituximab

Induction Chemotherapy: 375mg/m2, Intravenous administration on day 0 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles.

DRUG

Lenalidomide

Induction Chemotherapy: 25mg, oral administration on day 1 to 10 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles. Maintenance Treatment: 10mg oral administration on day 1 to 21 repeated every 4 weeks until disease progression or unacceptable toxicity develops, up to 12 cycles.

DRUG

Methotrexate

Induction Chemotherapy: 3mg/m2, Intravenous administration (pumping for 3h) on day 1 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles.

DRUG

Temozolomide

Induction Chemotherapy: 150mg/m2/d oral administration on day 1 to 10 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles.

Sponsors & Collaborators

  • Henan Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Zhihua Yao, M.D. Ph.D · Henan Cancer Hospital

  • Yanyan Liu, M.D. Ph.D · Henan Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-13
Primary Completion
2025-06-30
Completion
2026-01-13

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04737889 on ClinicalTrials.gov