Pro-miniCHOP-like Regimen for Treatment-naive Elderly Patients

Last updated: April 18, 2023
Sponsor: The First Affiliated Hospital of Soochow University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma, B-cell

Treatment

N/A

Clinical Study ID

NCT05809180
Jinzm 005
  • Ages > 70
  • All Genders

Study Summary

The proposed study is a prospective, single-center and open-ended study in patients over the age of 70 with treatment-naive diffuse large B-cell lymphoma (DLBCL). This study intends to explore a new treatment pattern using Pro-miniCHOP-like regimen and simultaneously evaluate its safety and efficacy for future clinical practice.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histopathologically or Cytologically confirmed newly diagnosed untreated DLBCL;
  2. There is at least one radiographically measurable lesion (i.e., ≥ 15mm in diameter);
  3. Age ≥ 70 years;
  4. Life expectancy >3 months;
  5. Patients with proper organic function (alanine aminotransferase, bilirubin, creatinine < 3 times the upper limit of normal; cardiac ejection fraction ≥ 50%; SPO2>90% undernon-oxygenated conditions).
  6. Written informed consent obtained from the subject.

Exclusion

Exclusion Criteria:

  1. Patients with severe liver and kidney dysfunction (alanine aminotransferase,bilirubin, creatinine > 3 times the upper limit of normal);
  2. Patients with organic heart disease with clinical symptoms or cardiac dysfunction (NYHA grade ≥2);
  3. Uncontrolled active infection;
  4. Patients with central nervous system DLBCL;
  5. A history of vascular embolism;
  6. Co-existence of other tumors;
  7. Systemic corticosteroid therapy is needed;
  8. Any other psychological conditions that prevent patients from participating in thestudy or signing the informed consent form.

Study Design

Total Participants: 35
Study Start date:
January 04, 2023
Estimated Completion Date:
July 03, 2026

Study Description

The study will start with an initial 21-days of induction therapy with combination of orelabrutinib, pomalidomide and rituximab(Pro regimen) in eligible patients, following contrast computed temography(CT) to guide the next treatment. Patients whose lesions have 25% or more reduction will next receive Pro-miniCHOP-like regimen for 6 cycles. Patients with reduction less than 25% will receive R-miniCHOP-like regimen also for 6 cycles. After that, maintenance therapy with pomalidomide for two years will be given to patients undergoing Pro-miniCHOP-like regimen.

Connect with a study center

  • the First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

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