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NCT06921044Not yet recruitingPhase 2

A Study of R-mini-MCOP in the Treatment of Elderly, Previously Untreated DLBCL

A Multicenter, Prospective Phase Ⅱ Clinical Study of R-mini-MCOP(Rituximab / Mitoxantrone Liposome / Cyclophosphamide / Vincristine / Prednisone) in the Treatment of Elderly, Previously Untreated Diffuse Large B-cell Lymphoma

Source: ClinicalTrials.gov · Last updated 10 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Research purpose: To evaluate the efficacy and safety of R-mini-MCOP in first-line treatment of primary treatment of diffuse large B-cell lymphoma (DLBCL) in elderly patients Experimental design: Single-arm, multicenter, prospective study

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
33 (estimated)
First submitted
25 Feb 2025
Start date
16 Apr 2025
Primary completion date
1 Feb 2026
Lead sponsor
Xiaohui He
NCT number
NCT06921044

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 33
  • From 16 Apr 2025 to the primary completion date, 1 Feb 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous systemic antitumor therapy (except pre-therapy used before the first cycle of R-CMOP);
  • Hypersensitivity to any investigational drug or its ingredients;
  • Previous or current co-occurrence of other malignancies (other than non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years);
  • Inability to swallow the drug or any significant removal of the small intestine that may prevent full absorption of the drug;

Other illness

  • Uncontrollable systemic diseases (such as advanced infections, uncontrolled hypertension, diabetes, etc.);
  • Hepatitis B and hepatitis C active infection (hepatitis B virus surface antigen positive and hepatitis B virus DNA more than 1x103 copies /mL; More than 1x103 copies /mL of HCV RNA);
  • Human immunodeficiency virus (HIV) infection (HIV antibody positive);

Other

  • Metastatic diffuse large B-cell lymphoma;
  • Known central nervous system lymphoma
  • Other serious comorbidities, intolerance to this protocol or inappropriate participation in this study (judged by the investigator)
  • Situations in which other investigators have determined that participation in this study is not appropriate.

Who the study is looking for

  • Age ≥ 80 years
  • The histopathological diagnosis was diffuse large B-cell lymphoma, and immunohistochemistry was positive for CD20
  • Previously untreated disease
  • Ann Arbor stage I-IV disease
  • According to Lugano2014 criteria, there must be at least one matching evaluable or measurable lesion: lymph node lesion, the length of the measurable lymph node must be greater than 1.5cm; For non-lymph node lesions, the measured extra-nodal lesions should be \> 1.0cm in length;
  • ECOG score 0-4(ECOG score 0-2 after pre-treatment and before R-mini-MCOP regimen)
  • Bone marrow function: neutrophil count ≥1.5×109/L, platelet count ≥75×109/L, hemoglobin ≥80g/L (neutrophil count ≥1.0×109/L, platelet count ≥50×109/L, hemoglobin ≥75 g/L in patients with bone marrow involvement);
  • Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal (≤5 times the upper limit of normal for patients with liver invasion); Total bilirubin ≤1.5 times the upper limit of normal value (≤3 times the upper limit of normal value for patients with liver invasion;
  • Have the swallowing power
  • Life expectancy \> 3 months
  • Patients fully understand the study, voluntarily participate and sign an informed consent form (ICF) -

Age in the registry: 80 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.