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NCT Number: NCT04737889

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

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.

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Key information

Conditions

Primary Central Nervous System Lymphoma

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

Location status: Recruiting

Location contact

Yanyan Liu, M.D. Ph.D

CONTACT

[email protected]

+8613818176375

Yanyan Liu, M.D. Ph.D

PRINCIPAL_INVESTIGATOR

Zhihua Yao, M.D. Ph.D

CONTACT

[email protected]

+8613592622292

Zhihua Yao, M.D. Ph.D

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: RiTUXimab Injection

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.

Other names: Lenalidomide capsule

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.

Other names: Methotrexate Injectable Solution

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.

Other names: Temozolomide capsule

Primary outcomes

  1. 2-year progression-free survival

    Time frame: 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)

    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

Secondary outcomes

  1. objective response rate

    Time frame: 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)

    the total proportion of patients with complete response (CR) and partial response (PR)

  2. overall survival

    Time frame: 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)

    from date of first day of treatment to the date of death by any cause

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

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

    the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03)

Study contacts

Contact information is provided by the study sponsor or research team.

Yanyan Liu, M.D. Ph.D

CONTACT

[email protected]

+8613838176375

Zhihua Yao, M.D. Ph.D

CONTACT

[email protected]

+8613592622292

Sponsors and collaborators

Lead sponsor

Henan Cancer Hospital

Other Gov

Registry information

Official study title

A Single Arm, Multi-center, Phase II Clinical Trial 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Feb 4, 2021
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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