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

May 17, 2023 updated by: Zhihua Yao, PhD, Henan Cancer Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yanyan Liu, M.D. Ph.D
  • Phone Number: +8613838176375
  • Email: yyliu@zzu.edu.cn

Study Contact Backup

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
        • Contact:
        • Principal Investigator:
          • Yanyan Liu, M.D. Ph.D
        • Contact:
        • Principal Investigator:
          • Zhihua Yao, M.D. Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age between 18 to 70 years old (including 18 and 70)
  2. Diagnosed as primary central nervous system lymphoma (limited to the brain, spinal cord, meninges and eyeballs, without involvement of other parts)
  3. 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)
  4. Having at least one measurable lesions
  5. 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)
  6. Life expectancy no less than 1 month
  7. enough main organ function
  8. 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
  9. Agreeing to sign the written informed consents

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RL-MT

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
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
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.

Other Names:
  • Lenalidomide capsule
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.
Other Names:
  • Methotrexate Injectable Solution
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.
Other Names:
  • Temozolomide capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Cancer Hospital

Investigators

  • Study Director: Yanyan Liu, M.D. Ph.D, Henan Cancer Hospital
  • Study Director: Zhihua Yao, M.D. Ph.D, Henan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2021

Primary Completion (Anticipated)

January 13, 2024

Study Completion (Anticipated)

January 13, 2026

Study Registration Dates

First Submitted

January 30, 2021

First Submitted That Met QC Criteria

January 30, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HNSZLYYNHL04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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