Actively Recruiting

Phase 1
Phase 2
Age: 65Years +
All Genders
NCT06683885

A Prospective Clinical Study of the Combination Therapy of Obutinib or Decitabine with Rituximab, Cyclophosphamide, and Prednisone for the Primary Treatment of Elderly Patients with Newly Diagnosed Diffuse Large B-cell Lymphoma

Led by Mingzhi Zhang · Updated on 2024-11-12

80

Participants Needed

1

Research Sites

75 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A Prospective Clinical Study of the Combination Therapy of Obutinib or Decitabine with Rituximab, Cyclophosphamide, and Prednisone for the Primary Treatment of Elderly Patients with newly Diagnosed Diffuse Large B-cell Lymphoma

CONDITIONS

Official Title

A Prospective Clinical Study of the Combination Therapy of Obutinib or Decitabine with Rituximab, Cyclophosphamide, and Prednisone for the Primary Treatment of Elderly Patients with Newly Diagnosed Diffuse Large B-cell Lymphoma

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals aged 65 years or older who are intolerant to chemotherapy
  • ECOG performance status 0 or 1; IPI score 3 or less
  • Expected survival of more than 3 months
  • Diagnosis of diffuse large B-cell lymphoma confirmed by tissue biopsy
  • No chemotherapy contraindications; blood counts meeting specified thresholds within 7 days
  • At least one measurable lesion according to RECIST criteria
  • Liver function within specified limits
  • Renal function within specified limits
  • No serious illnesses conflicting with study plan
  • Normal heart function excluding other major illnesses
  • No other related treatments except bone metastasis or symptom treatments
  • Voluntary participation with signed informed consent and willingness to follow-up
  • No use of other anti-tumor drugs during treatment except bisphosphonates for bone metastasis and symptom management
Not Eligible

You will not qualify if you...

  • Presence of neurological or psychiatric disorders including dementia, seizures, or history of psychotropic drug abuse
  • Participation in other clinical trials within 4 weeks prior to enrollment
  • Systemic autoimmune diseases or immunodeficiency
  • Refusal to provide blood samples
  • Allergy to any study medications
  • Pregnancy or breastfeeding
  • Major diseases causing experimental interference or uncontrolled active infections
  • Primary or secondary central nervous system tumors
  • Chemotherapy contraindications
  • Use of Rituximab, Obutinib, Cyclophosphamide, or Azacitidine within 28 days
  • Investigator judgment deeming unsuitability
  • Active infections requiring intravenous antibiotics or recent hospitalization
  • Use of other anti-tumor treatments such as radiotherapy, chemotherapy, hormone therapy, biotherapy, or immunotherapy
  • Serious diseases restricting participation such as uncontrolled diabetes, severe heart failure (NYHA II or above), recent acute coronary syndrome or major heart surgeries, severe arrhythmias, uncontrolled hypertension, gastric ulcer at risk of perforation, active autoimmune diseases, or severe respiratory diseases
  • Bloodthirsty cell syndrome
  • Positive tests for hepatitis B, hepatitis C, HIV, Cytomegalovirus, or syphilis infections with abnormal viral markers or DNA levels

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

Oncology Department of The First Affilliated Hospital of Zhengzhou University

Zhengzhou, Henan, China, 450052

Actively Recruiting

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Research Team

M

Mingzhi Zhang, Doctor

CONTACT

L

Lei Zhang, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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