A-RGEMOX in the Treatment of Early Relapsed/Refractory DLBCL

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT06086197
Phase
PHASE2
Status
Recruiting
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Conditions

  • Diffuse Large B Cell Lymphoma Refractory
  • Diffuse Large B-cell Lymphoma Recurrent

Eligibility Criteria

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

Interventions

  • Anlotinib hydrochloride, Rituximab, gemcitabine, oxaliplatin — DRUG
    Anlotinib: 12mg d1\~14 po qd, Rituximab: 375mg/m2 d1, gemcitabine: 1000mg/m2 d1 and d8, oxaliplatin: 130mg/m2 d1; For subjects ≥75 years of age, appropriate reduction of chemotherapy drugs (not less than 75% of the standard dose, or withdrawal of day 8 gemcitabine) may be decided by the investigator.

Study Details

As the most common subtype of lymphoma, diffuse large B-cell lymphoma (DLBCL) is an aggressive but potentially curable malignancy. However, patients with early relapse (relapse within 12 months since diagnosis or the end of first-line treatment, ER) or primary refractory had an even worse prognosis. Thus, the investigators plan to evaluate the efficacy and safety of anlotinib combined with rituximab, gemcitabine, oxaliplatin (A-RGEMOX) in the treatment of early relapsed/refractory diffuse large B-cell lymphoma.

Key Dates

Start date
Oct 1, 2023
Status verified
Jun 2024
Primary completion
Oct 1, 2025
Completion
Oct 31, 2026

Study Design

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

Arms

  • Experimental: A+RGEMOX
    A-RGEMOX regimen (21 days per cycle, A total of 6 cycles) : Allotinib: 12mg d1\~14 po qd, Rituximab: 375mg/m2 d1, gemcitabine: 1000mg/m2 d1 and d8, oxaliplatin: 130mg/m2 d1

Primary Outcome Measure

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

Central Contacts

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