A Trial to Compare Ibrutinib Versus Lenalidomide in Combination With MRE-chemotherapy for Adult Patients With Recurrent/Refractory Primary Central Nervous System Lymphoma (PCNSL)

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT04129710
Phase
PHASE2
Status
Unknown

Conditions

  • Recurrent/RefractoryPrimary Central Nervous System Lymphoma (PCNSL)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Ibrutinib 560 mg/day daily (starting dose) between days 4 and 28 of each cycle for six cycles. Then Ibrutinib is continued until disease progression, intolerable toxicity, death or up to two years.
  • Lenalidomide — DRUG
    Oral lenalidomide 25mg/day between days 4 and 24 of each cycle for six cycles. Then lenalidomide is continued until disease progression, intolerable toxicity, death or up to two years.
  • Methotrexate — DRUG
    Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min + 3 g/m2 in 3-hr infusion) on day 1
  • Rituximab — DRUG
    Rituximab 375 mg/m2 conventional infusion on day 1
  • Etoposide — DRUG
    Etoposide 250 mg/m2 over 3 hours on day3
  • PEGylated recombinant human granulocyte colony — DRUG
    PEGylated recombinant human granulocyte colony 100 ug/kg subcutaneous injection on day 5.

Study Details

This is a open-label，multicenter, randomised, three-arm, phase II efficacy and safety study of ibrutinib in combination with MRE(methotrexate,rituximab,etoposide)-chemotherapy versus lenalidomide in combination with MRE-chemotherapy given to adult patients who have recurrent/refractory primary central nervous system lymphoma (PCNSL)

Key Dates

Start date
Jan 1, 2020
Status verified
Jan 2021
Primary completion
Dec 31, 2023
Completion
Dec 31, 2025

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: I-MRE
    Ibrutinib 560 mg/day daily (starting dose) between days 4 and 28 of each cycle for six cycles. Then Ibrutinib is continued until disease progression, intolerable toxicity, death or up to two years. Methotrexate (standard hydration/leucovorin support) 3.5 g/m2 (0.5 g/m2 in 15 min+ 3 g/m2 in 3-hr infusion) d2. Rituximab 375 mg/m2 conventional infusion d1.Etoposide 250 mg/m2 over 3 hours on day3. Every 4 weeks for 1 cycle, 6 cycles will be prescribed as protocol.
  • Experimental: L-MRE
    Oral lenalidomide 25mg/day (starting dose) between days 4 and 24 of each cycle for six cycles.Then lenalidomide is continued until disease progression, intolerable toxicity, death or up to two years. Methotrexate (standard hydration/leucovorin support) 3.5 g/m2 (0.5 g/m2 in 15 min+ 3 g/m2 in 3-hr infusion) d2. Rituximab 375 mg/m2 conventional infusion d1. Etoposide 250 mg/m2 over 3 hours on day3. Every 4 weeks for 1 cycle, 6 cycles will be prescribed as protocol.
  • Active Comparator: MRE
    Methotrexate (standard hydration/leucovorin support) 3.5 g/m2 (0.5 g/m2 in 15 min+ 3 g/m2 in 3-hr infusion) d2. Rituximab 375 mg/m2 conventional infusion d1. Etoposide 250 mg/m2 over 3 hours on day3. Every 4 weeks for 1 cycle, 6 cycles will be prescribed as protocol. Patients who will not achieve SD or better after the 4th course, as well as those who will experience Progressive Disease (PD) at any time will be randomly allocated to the Experimental groups.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: assessed up to 2 yrs ]

Central Contacts