Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06701357

CR-CHOP+X in Previously Untreated DEL

Led by Ruijin Hospital · Updated on 2024-12-30

49

Participants Needed

1

Research Sites

207 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a prospective, single-arm, open-label phase II clinical trial that evaluates the efficacy and safety of CR-CHOP regimen combined with different targeted drugs based on different molecular subtypes in newly diagnosed DEL patients.

CONDITIONS

Official Title

CR-CHOP+X in Previously Untreated DEL

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed diffuse large B-cell lymphoma with CD20 positive
  • MYC and BCL2 are expressed simultaneously, MYC ≥40%, BCL2 ≥50%
  • Age 18 to 75 years old
  • ECOG physical status score of 0, 1 or 2
  • No previous history of malignant tumors or simultaneous other tumors
  • Life expectancy of at least 6 months as judged by investigator
  • Written informed consent provided by patient or legal representative
  • International prognostic Index (IPI) score greater than 1
Not Eligible

You will not qualify if you...

  • Previously received systemic or local treatment including chemotherapy
  • Previously received autologous stem cell transplantation
  • Previous history of other malignant tumors except skin basal cell carcinoma and cervical carcinoma in situ
  • Uncontrolled cardiovascular, cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, or other diseases
  • Primary central nervous system lymphoma
  • Left ventricular ejection fraction 50% or lower
  • Laboratory abnormalities at screening unrelated to lymphoma: neutrophils below 1.510^9/L, platelets below 7510^9/L, elevated liver enzymes or bilirubin above specified limits, elevated creatinine above 1.5 times upper limit
  • Other uncontrolled medical conditions affecting study participation
  • Mental illness or inability to comply with study protocol
  • Pregnant or lactating women
  • Living with HIV
  • Positive HbsAg test requiring HBV DNA test and negative result before enrollment; similarly, positive HBcAb with positive HBV DNA requires negative treatment before admission

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

No. 197 Ruijin 2nd Road, Huangpu District, Shanghai

Shanghai, Shanghai Municipality, China

Actively Recruiting

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Research Team

L

Li Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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CR-CHOP+X in Previously Untreated DEL | DecenTrialz