ZR2 Followed by Immunochemotherapy in Elderly Patients With Newly-diagnosed DLBCL

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT05290090
Phase
PHASE2
Status
Unknown

Conditions

  • Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
65 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab, Lenalidomide, Zanubrutinib and RCHOP — DRUG
    chemo free period (21 days as a cycle, a total of 2 cycles): rituximab 375mg/m2, d1, lenalidomide 10mg qd d1-10, zanubrutinib 160mg bid. Immunochemotherapy period: RCHOP regimen (21 days as 1 cycle, a total of 4 cycles): rituximab 375mg/m2 d0, cyclophosphamide: 750mg/m2 d1, epirubicin: 75mg/m2 d1 (or liposomal doxorubicin 35mg/m2 d1), vindesine 4mg d1, prednisone: 100mg, d1-5.

Study Details

As the most common subtype of lymphoma, diffuse large B-cell lymphoma (DLBCL) is an aggressive but potentially curable malignancy. The poor prognosis of elderly DLBCL patients may be related to the biological behavior of the disease, more comorbidities, poor performance status, and inability to tolerate standard-intensity immunochemotherapy. The investigators plan to use ZR2 regimen(rituximab, lenalidomide and zanubrutinib) for 2 cycles followed by immunochemotherapy for up to 4 cycles in elderly newly diagnosed DLBCL patients.

Key Dates

Start date
Oct 1, 2021
Status verified
Oct 2023
Primary completion
Jun 1, 2024
Completion
Dec 1, 2025

Study Design

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

Arms

  • Experimental: Rituximab, lenalidomide, zanubrutinib and RCHOP
    Rituximab, lenalidomide, zanubrutinib for 2 cycles: rituximab 375mg/m2, d1, lenalidomide 10mg qd d1-10, zanubrutinib 160mg bid. RCHOP for 4 cycles: rituximab 375mg/m2 d0, cyclophosphamide: 750mg/m2 d1, epirubicin: 75mg/m2 d1 (or liposomal doxorubicin 35mg/m2 d1), vindesine 4mg d1, prednisone: 100mg, d1-5.

Primary Outcome Measure

ORR [ Time Frame: 21days after the end of treatment ]

Central Contacts

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