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

NCT04737889 | Recruiting Phase 2 DMC

• 1 other identifier: HNSZLYYNHL04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Primary Central Nervous System Lymphoma

Keywords

Primary Central Nervous System Lymphoma; RL-MT

Outcome Measures

Primary Outcomes (1)

• 2-year progression-free survival

  the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first

  from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment (each cycle is 21 days)

Secondary Outcomes (3)

• objective response rate

  every 6 weeks from the day of the first cycle of induction chemotherapy treatment and every 8 weeks from the day of the first cycle of maintenance treatment to 18 months after last patient's enrollment (each cycle is 21 days)

• overall survival

  from date of the first cycle of treatment to the date of death from any cause, assessed up to 5 years (each cycle is 21 days)

• incidence and relationship with study drugs of grade 3-4 adverse events

  from the date of the first cycle of treatment to 18 months after last patient's enrollment (each cycle is 21 days)

Study Arms (1)

RL-MT

EXPERIMENTAL

Induction Chemotherapy: Rituximab, 375mg/m2, Intravenous administration on day 0, Lenalidomide, 25mg oral administration on day 1 to 10, combined with regimen: Methotrexate, 3mg/m2, Intravenous administration (pumping for 3h) on day 1 of each 3-week cycle, Temozolomide, 150mg/m2/d oral administration on day 1 to 10. Consolidation Treatment: Autologous hematopoietic stem cell transplantation or reduced whole brain radiotherapy after high-dose chemotherapy. Maintenance Treatment: Lenalidomide, 10mg oral administration on day 1 to 21 of each 4-week cycle for 12 months.

Drug: Rituximab; Drug: Lenalidomide; Drug: Methotrexate; Drug: Temozolomide

Interventions

Rituximab DRUG

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.

Also known as: RiTUXimab Injection

RL-MT

Lenalidomide DRUG

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.

Also known as: Lenalidomide capsule

RL-MT

Methotrexate DRUG

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.

Also known as: Methotrexate Injectable Solution

RL-MT

Temozolomide DRUG

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.

Also known as: Temozolomide capsule

RL-MT

Eligibility Criteria

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

You may qualify if:

• Age between 18 to 70 years old (including 18 and 70)
• Diagnosed as primary central nervous system lymphoma (limited to the brain, spinal cord, meninges and eyeballs, without involvement of other parts)
• Having not received anti-tumor therapy before enrollment (except for tumor resection and biopsy and the use of glucocorticoids to reduce central nervous system symptoms)
• Having at least one measurable lesions
• World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 ( ECOG 3 due to tumors can be included after being fully assessed by the investigator)
• Life expectancy no less than 1 month
• enough main organ function
• Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
• Agreeing to sign the written informed consents

You may not qualify if:

• Diagnosed as secondary central nervous system lymphoma
• Diagnosed as CD20 negative large B cell primary central nervous system lymphoma
• Active malignant tumor need be treated at the same time
• Other malignant tumor history
• Serious surgery and trauma less than two weeks
• Patients with active tuberculosis
• Systemic therapy for serious acute/chronic infection
• Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
• HIV-positive, AIDS patients and untreated active hepatitis
• Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
• Patients with a history of mental illness or drug abuse
• Poor compliance during the trial and/or follow-up phase
• Allergies or people who are known to be allergic to any active ingredients, excipients, mouse-derived products or heterologous protein contained in this trial
• Researchers determine unsuited to participate in this trial

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Interventions

Rituximab; Lenalidomide; Methotrexate; Temozolomide

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; Dacarbazine; Triazenes; Imidazoles; Azoles

Study Officials

• Zhihua Yao, M.D. Ph.D

  Henan Cancer Hospital

  STUDY DIRECTOR

• Yanyan Liu, M.D. Ph.D

  Henan Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

Zhihua Yao, M.D. Ph.D

CONTACT

+8613592622292; zlyyyaozhihua1260@zzu.edu.cn

Yanyan Liu, M.D. Ph.D

CONTACT

+8613838176375; yyliu@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 30, 2021
• First Posted: February 4, 2021
• Study Start: January 13, 2021
• Primary Completion: June 30, 2025
• Study Completion: January 13, 2026
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

CN (1)