Ibrutinib With Methotrexate and Temozolomide for Patients With Newly Diagnosed Primary CNS Lymphoma

Sponsor
Huiqiang Huang
Study ID
NCT04514393
Phase
PHASE2
Status
Unknown

Conditions

  • Non Hodgkin Lymphoma
  • PCNSL
  • Primary Central Nervous System Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Methotrexate — DRUG
    Intravenous methotrexate at 3.5g/m2 (standard hydration/leucovorin support) will be given on day 1 of all cycles，for up to 4 cycles.
  • Ibrutinib — DRUG
    Oral ibrutinib will be given at a dose of 560 mg daily and will be continued daily after completion of methotrexate and temozolomide.Ibrutinib is continued until disease progression, intolerable toxicity or death.
  • Temozolomide — DRUG
    Oral temozolomide will be given at 150mg/m2 from day1 to day 5 every 4 of all cycles，for up to 4 cycles.

Study Details

The purpose of the study is to test the efficacy and tolerability of a combination treatment of methotrexate, ibrutinib, and temozolomide (MIT regimen) in treating patients who have newly-diagnosed primary CNS lymphoma.

Key Dates

Start date
Oct 10, 2020
Status verified
Apr 2022
Primary completion
Sep 1, 2022
Completion
Jun 1, 2024

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: methotrexate, ibrutinib, and temozolomide (MIT regimen)
    Methotrexate will be given on day 1 of each 28-day cycle；Ibrutinib will be given day 1-28 of each 28-day cycle; Temozolomide will be given day 1-5 of each 28-day cycle. Methotrexate and Temozolomide are given for up to 4 cycles; Ibrutinib is continued until disease progression, intolerable toxicity, or death.

Primary Outcome Measure

the overall response (complete response + partial response)，Investigator-Assessed [ Time Frame: up to 24 months ]

Central Contacts

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