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New treatment option for 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
ClinicalTrials.gov ID: NCT06683885
What this study is testing
What is Obutinib or Decitabine, Rituximab, Compound Cyclophosphamide Tablets and Prednisone?
Obutinib or Decitabine, Rituximab, Compound Cyclophosphamide Tablets and Prednisone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for newly diagnosed diffuse large b-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 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 ≥...
You likely can't join if
- Clear patients with neurological or psychiatric disorders, including dementia or seizures, a history of abuse of psychotropic drugs that cannot be...
- Individuals who are currently participating in other clinical trials or have participated in other clinical studies within the first 4 weeks of...
- Systemic autoimmune diseases or immunodeficiency;
- Refusing to collect blood samples;
- Allergic to any medication in the plan;
- Pregnant and lactating women;
See the full eligibility criteria
- 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...
- 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...
- 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 people 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;
- 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...
- 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);
- Systemic autoimmune diseases or immunodeficiency;
- Refusing to collect blood samples;
- Allergic to any medication in the plan;
- Pregnant and lactating women;
- Major diseases that can cause experimental interference and uncontrolled active infections;
- Primary or secondary central tumors;
- Chemotherapy contraindications;
- Within 28 days of using Rituximab/Obutinib/Compound Cyclophosphamide Tablets/Azacitidine;
- Researchers believe that it is not suitable for inclusion;
- 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...
- Apply other anti-tumor treatments (such as radiotherapy, chemotherapy, hormone therapy, biotherapy, immunotherapy);
- Other serious diseases that may restrict the people 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.