R-MINE+X in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT05784987
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    375 mg/m2, d0, Cycle 1\~4
  • Mitoxantrone hydrochloride liposome — DRUG
    20 mg/m2, d1, Cycle 1\~4
  • Isophosphamide — DRUG
    1.33 g/m2, d1-3(Rescue with equal dose of mesperidine), Cycle 1\~4
  • Etoposide — DRUG
    65 mg/m2, d1-3, Cycle 1\~4
  • X: Orelabrutinib — DRUG
    MCD/BN2 subtype: BTK inhibitor-Orelabrutinib: 150 mg/d, d1-21, Cycle 2\~4
  • X: Chidamide — DRUG
    EZB subtype: Chidamide: 20 mg/d, d1, d4, d8, d11, Cycle 2\~4
  • X: Penpulimab — DRUG
    TP53 mutation - X: PD-1 monoclonal antibody - Penpulimab: 200mg/d, d0, Cycle 2\~4
  • X: Lenalidomide — DRUG
    Other-X: Lenalidomide: 25mg/d, d1-10, Cycle 2\~4

Study Details

Based on the modified R-MINE of mitoxantrone hydrochloride liposome, the corresponding targeted drug (X) was added according to the genotyping detected by second-generation gene sequencing (NGS) to explore the effectiveness and safety of R-MINE+X in the treatment of recurrent/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

Key Dates

Start date
Apr 15, 2023
Status verified
Mar 2023
Primary completion
Jan 1, 2024
Completion
Jan 1, 2025

Study Design

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

Arms

  • Experimental: R-MINE+X
    R-MINE: Rituximab, Isophosphamide, Mitoxantrone hydrochloride liposome, Etoposide X: Orelabrutinib, Chidamide, Penpulimab, Lenalidomide

Primary Outcome Measure

Objective Response Rate(ORR) [ Time Frame: up to 4 cycles of chemotherapy(each cycle is 21 days) ]

Central Contacts

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