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

Sponsor
Henan Cancer Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04737889
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
60
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Jan 13, 2021
Anticipated Primary Completion Date :
Jan 13, 2024
Anticipated Study Completion Date :
Jan 13, 2026

Arms and Interventions

ArmIntervention/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
  • Outcome Measures

    Primary Outcome Measures

    1. 2-year progression-free survival [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 Outcome Measures

    1. 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)]

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

    2. 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)]

      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 [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou universityZhengzhouHenanChina

    Sponsors and Collaborators

    • Henan Cancer Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    yaozhihua, Director, Henan Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT04737889
    Other Study ID Numbers:
    • HNSZLYYNHL04
    First Posted:
    Feb 4, 2021
    Last Update Posted:
    Feb 4, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by yaozhihua, Director, Henan Cancer Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 4, 2021