A-RGEMOX in the Treatment of Early Relapsed/Refractory DLBCL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participate in the clinical study voluntarily: fully understand and be informed of the study and sign the informed consent in person; Willing to follow and be able to complete all test procedures.
Age≥18 years old, ECOG score ≥2 points, both male and female.
Histopathologically confirmed as diffuse large B-cell lymphoma, not otherwise specified; high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement; high-grade B-cell lymphoma, not otherwise specified; EBV positive diffuse large B-cell lymphoma
Early relapse: response (≥PR) to first-line systemic therapy (including rituximab and anthracyclines) and disease progression within 12 months after the end of treatment;
Disqualifiers
Pathological subtypes: primary central nervous system diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma.
Hemophagocytic syndrome at the time of diagnosis.
Central nervous system involvement secondary to lymphoma.
Participating in other clinical studies, or the first study drug is administered less than 4 weeks after the end of treatment in the previous clinical study.
Trial design
Design model
Single group
Treatments tested in this trial
Anlotinib hydrochloride, Rituximab, gemcitabine, oxaliplatin
DrugAnlotinib: 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.
Treatment groups
41 Participants
are divided into 1 treatment groupGroup A: A+RGEMOXExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
CRR
Complete Remission Rate
Time frame
21days after the end of treatmentSecondary outcomes
1
ORR
overall response rate
Time frame
21days after the end of treatment2
PFS
Progression Free Survival
Time frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years3
OS
Overall Survival
Time frame
From date of enrollment until the date of first documented date of death from any cause, assessed up to 5 years4
PRR
Partial Remission Rate
Time frame
21days after the end of treatmentSponsors and contacts
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Source ClinicalTrials.gov