NCT06683885RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 12 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 8 Nov 2024
- Start date
- 20 Nov 2024
- Primary completion date
- 1 May 2026
- Lead sponsor
- Mingzhi Zhang
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT06683885
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 80
- From 20 Nov 2024 to the primary completion date, 1 May 2026
- 1 site in 1 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
- Individuals who are currently participating in other clinical trials or have participated in other clinical studies within the first 4 weeks of enrollment (excluding those who have not received treatment);
- Chemotherapy contraindications;
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infections (excluding nail bed skin fungal infections) or any major systemic infection requiring intravenous antibiotic treatment or hospitalization within the 4 weeks prior to enrollment (excluding tumor fever);
- Apply other anti-tumor treatments (such as radiotherapy, chemotherapy, hormone therapy, biotherapy, immunotherapy);
Other illness
- Clear patients with neurological or psychiatric disorders, including dementia or seizures, a history of abuse of psychotropic drugs that cannot be quit, or other substantial lesions that may increase central neurotoxicity;
- Systemic autoimmune diseases or immunodeficiency;
- Allergic to any medication in the plan;
- Major diseases that can cause experimental interference and uncontrolled active infections;
- Other serious diseases that may restrict the subjects from participating in the test, such as uncontrollable diabetes; Severe heart failure (NYHA grade II or above); Acute coronary syndrome has occurred within the past 6 months; Coronary revascularization such as stent implantation, coronary artery bypass surgery, and other heart and large vessel related surgeries within the past 6 months; Severe arrhythmias include frequent premature ventricular contractions, ventricular tachycardia, rapid atrial fibrillation/flutter, and severe bradycardia. Uncontrolled hypertension: systolic blood pressure\>150mmHg, diastolic blood pressure\>100mmHg. Gastric ulcer (determined by researchers to have a risk of perforation); Active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, etc.); Severe respiratory diseases (such as obstructive pulmonary disease and history of bronchospasm), etc;
- Individuals with bloodthirsty cell syndrome;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive and the detection of hepatitis B virus (HBV) DNA titer in peripheral blood is not within the normal reference value range; Individuals with positive hepatitis C virus (HCV) antibodies and positive hepatitis C virus (HCV) RNA in peripheral blood; Individuals who are HIV antibody positive; Individuals who test positive for Cytomegalovirus (CMV) DNA; Individuals who test positive for syphilis.
Other
- Refusing to collect blood samples;
- Pregnant and lactating women;
- Primary or secondary central tumors;
- Within 28 days of using Rituximab/Obutinib/Compound Cyclophosphamide Tablets/Azacitidine;
- Researchers believe that it is not suitable for inclusion;
Who the study is looking for
- Individuals aged 65 years or older who are intolerant to chemotherapy, regardless of gender;
- ECOG 0-1; IPI score ≤ 3 points;
- Expected survival period of more than 3 months;
- DLBCL diagnosed by tissue biopsy pathology;
- No contraindications for chemotherapy (blood and physiological examination results within 7 days), absolute neutrophil count ≥ 1.0 × 10 \^ 9/L, PLT ≥ 75 × 10 \^ 9/L, hemoglobin ≥ 80g/L (excluding patients with lymphoma bone marrow infiltration);
- According to the RECIST criteria, there must be at least one measurable lesion. For intranodal lesions, it is defined as: long diameter ≥ 1.5cm and short diameter ≥ 1.0cm; For extranodal lesions, the length and diameter should be ≥ 1.0cm;
- Liver function: TBIL ≤ 1.5 × ULN; ALT or AST ≤ 2.5 × ULN; Non bone invasive patients with alkaline phosphatase ≤ 3 × ULN;
- Renal function: serum creatinine ≤ 1.5 × ULN;
- No other serious illnesses that conflict with this plan;
- Excluding other major illnesses, the heart function is normal;
- There are no other related treatments including traditional Chinese medicine (anti-tumor effects), immunotherapy, or biologic therapy (except for treatment of bone metastasis and other symptoms);
- The subjects voluntarily participate in the clinical trial, sign an informed consent form, and cooperate with follow-up;
- During this treatment period, if other anti-tumor drugs are not used simultaneously, bisphosphonates can be used for bone metastasis treatment and other symptomatic treatments;
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oncology Department of The First Affilliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.