Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Oncology Department of The First Affilliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
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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