Combination therapy for elderly patients with newly diagnosed diffuse large B-cell lymphoma
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
Run by Zhengzhou University · NCT06683885 · Data updated 2026-11-12
This study is testing a new combination treatment for older patients with newly diagnosed diffuse large B-cell lymphoma who can't tolerate standard chemotherapy to see if it helps them feel better and live longer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Zhengzhou University Academic / other |
| Drugs / interventions | Rituximab, Obutinib, chemotherapy, immunotherapy, Cyclophosphamide, Prednisone |
| Locations | 1 site (Zhengzhou, Henan) |
| Status | Recruiting |
| Started | November 20, 2024 |
| Main results expected | May 1, 2026 |
| Study ends | May 1, 2026 |
| Registry record updated | November 12, 2024 |
| Trial ID | NCT06683885 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 65 and older with newly diagnosed DLBCL who are intolerant to chemotherapy.
✕Probably not a fit
Patients with contraindications for chemotherapy or those with severe comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study evaluates the safety and efficacy of a combination therapy involving Obutinib or Decitabine alongside Rituximab, Cyclophosphamide, and Prednisone in elderly patients diagnosed with diffuse large B-cell lymphoma (DLBCL). The study employs an open-label, single-arm design to observe treatment outcomes in patients aged 65 and older who are intolerant to standard chemotherapy. Participants will be monitored for progression-free survival and overall response rates to determine the effectiveness of this novel treatment approach.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for elderly patients with DLBCL who cannot tolerate traditional chemotherapy.
How similar studies have gone: While there have been studies on combination therapies for DLBCL, this specific approach involving Obutinib or Decitabine is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Individuals aged 65 years or older who are intolerant to chemotherapy, regardless of gender; 2. ECOG 0-1; IPI score ≤ 3 points; 3. Expected survival period of more than 3 months; 4. DLBCL diagnosed by tissue biopsy pathology; 5. 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); 6. 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; 7. Liver function: TBIL ≤ 1.5 × ULN; ALT or AST ≤ 2.5 × ULN; Non bone invasive patients with alkaline phosphatase ≤ 3 × ULN; 8. Renal function: serum creatinine ≤ 1.5 × ULN; 9. No other serious illnesses that conflict with this plan; 10. Excluding other major illnesses, the heart function is normal; 11. 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); 12. The subjects voluntarily participate in the clinical trial, sign an informed consent form, and cooperate with follow-up; 13. 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; Exclusion Criteria: 1. 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; 2. 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); 3. Systemic autoimmune diseases or immunodeficiency; 4. Refusing to collect blood samples; 5. Allergic to any medication in the plan; 6. Pregnant and lactating women; 7. Major diseases that can cause experimental interference and uncontrolled active infections; 8. Primary or secondary central tumors; 9. Chemotherapy contraindications; 10. Within 28 days of using Rituximab/Obutinib/Compound Cyclophosphamide Tablets/Azacitidine; 11. Researchers believe that it is not suitable for inclusion; 12. 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); 13. Apply other anti-tumor treatments (such as radiotherapy, chemotherapy, hormone therapy, biotherapy, immunotherapy); 14. 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; 15. Individuals with bloodthirsty cell syndrome; 16. 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.
Where it's running
-
Oncology Department of The First Affilliated Hospital of Zhengzhou University
Zhengzhou, Henan, China Recruiting
Study contacts
- Study coordinator: Mingzhi Zhang, Doctor
- Email: Mingzhi_zhang@126.com
- Phone: 13838565629
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL
This trial tests whether a gentler, first-line treatment (Polatuzumab Vedotin with Rituximab and reduced-dose chemo) helps older, frail patients with DLBCL stay disease-free longer.
-
Orelabrutinib plus Pola-R-CHP as first-line treatment for intermediate- to high-risk DLBCL
This trial tests whether adding orelabrutinib to the Pola-R-CHP regimen can improve outcomes for adults with intermediate- to high-risk newly diagnosed DLBCL.
-
Polatuzumab vedotin with Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in untreated DLBCL (MCD/BN2/N1)
This study tests a targeted combination therapy to see if it can treat previously untreated DLBCL with specific molecular subtypes.
-
Epcoritamab plus dose‑adjusted EPOCH‑R for aggressive B‑cell lymphoma
This trial tests whether adding epcoritamab to dose‑adjusted EPOCH‑R chemotherapy can safely improve outcomes for adults with untreated aggressive B‑cell non‑Hodgkin lymphoma.
-
Evaluating R-CMOP treatment for newly diagnosed diffuse large B-cell lymphoma
This study is testing a new combination treatment for people with newly diagnosed diffuse large B-cell lymphoma to see if it is safe and effective.
-
Treatment for Richter Syndrome using Glofitamab with Rituximab or Obinutuzumab plus CHOP
This study is testing if a new treatment combining Glofitamab with Rituximab or Obinutuzumab and CHOP chemotherapy can help people with untreated Richter Syndrome feel better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.