Rituximab,Zanubrutinib in Combination With Lenalidomide, Followed by Zanubrutinib or Lenalidomide Maintenance in Patients With Primary or Secondary CNS Lymphoma

Sponsor
Henan Cancer Hospital
Study ID
NCT04938297
Phase
PHASE2
Status
Unknown

Conditions

  • Central Nervous System Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab, Lenalidomide, Zanubrutinib — DRUG
    Induction therapy: Rituximab 375 mg / m2, day 1, Zanubrutinib 160 mg bid, orally, Lenalidomide 25mg QD, orally on day 1-21, 28 days as a course of treatment, 8 courses of treatment.
  • Lenalidomide, Zanubrutinib — DRUG
    Maintenance therapy: Lenalidomide: 25mg qd (adjusted according to hectogram condition) or Zanubrutinib 160 mg bid. Continuously use for 2 years or until disease progression
  • Lenalidomide — DRUG
    Maintenance therapy: Lenalidomide: 25mg qd (adjusted according to hectogram condition) . Continuously use for 2 years or until disease progression

Study Details

In view of the synergistic effects of rituximab, zanubrutinib, and lenalidomide and severe complications caused by current standard chemotherapy regimens in Patients for primary or secondary CNS lymphoma, we intend to conduct a prospective clinical study to evaluate the efficacy and toxicity of Rituximab, Zanubrutinib in combination with Lenalidomide. Besides, the efficacy of Zanubrutinib or Lenalidomide in maintenance was also compared.

Key Dates

Start date
May 26, 2021
Status verified
Jun 2021
Primary completion
Oct 31, 2022
Completion
Dec 31, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Primary CNS Lymphoma，age>65
    8 cycles of induction ZR2 , followed by Zanubrutinib or Lenalidomide maintenance for CR/PR fit patients through randomization by 1:1 ration
  • Experimental: Recurrent/refractory primary CNS lymphoma
    8 cycles of induction ZR2, followed by Lenalidomide maintenance for CR/PR fit patients.
  • Experimental: Recurrent/refractory diffuse large B-cell lymphoma with CNS invasion
    8 cycles of induction ZR2, followed by Lenalidomide maintenance for CR/PR fit patients.

Primary Outcome Measure

Overall response rate [ Time Frame: at the end of 8 cycles of induction therapy (each cycle is 28 days) ]

Central Contacts

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