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

NCT06683885 | Recruiting Phase 1

• 1 other identifier: DLBCL20141010
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Newly Diagnosed Diffuse Large B-cell Lymphoma

Keywords

DLBCL; clinical trial; chemotherapy; PFS; ORR; Obutinib; Decitabine

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate (ORR)

  Overall Response Rate

  two years

• Progression Free Survival (PFS)

  Progression Free Survival

  two years

Secondary Outcomes (2)

• Overall Survival (OS)

  two years

• Disease free survival（DFS）

  two years

Study Arms (1)

Elderly patients with newly diagnosed DLBCL

EXPERIMENTAL

Obutinib or Decitabine with Rituximab, Compound Cyclophosphamide Tablets and Prednisone

Drug: Obutinib or Decitabine, Rituximab, Compound Cyclophosphamide Tablets and Prednisone

Interventions

Obutinib or Decitabine, Rituximab, Compound Cyclophosphamide Tablets and Prednisone DRUG

For non GCB type: Rituximab, 375mg/m2, QD, D1,8,15(the first cycle), d1(Starting from the second cycle), ivgtt; Compound Cyclophosphamide Tablets, 50mg:50mg BID, P.O.; Obutinib, 150mg, QD, P.O.; Prednisone, 60mg, QD D1-7, P.O. Every 21 days is a cycle, and the efficacy is evaluated every 2 cycles. Obutinib maintain treatment for 6 months. Obutinib, 150mg, QD, P.O. After 6 cycles of initial treatment, the efficacy was evaluated. For GCB type: Rituximab, 375mg/m2, QD, D1,8,15(the first cycle), d1(Starting from the second cycle), ivgtt; Compound Cyclophosphamide Tablets, 50mg:50mg BID, P.O.; Decitabine, 10mg, QD，D1-5, ivgtt; Prednisone, 60mg, QD D1-7, P.O. Every 21 days is a cycle, and the efficacy is evaluated every 2 cycles. Decitabine maintenance treatment for 4 cycles, 21 days per cycle. Decitabine, 10mg, QD，D1-5, ivgtt. Evaluate the efficacy after 6 cycles of treatment.

Elderly patients with newly diagnosed DLBCL

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify 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 ≥ 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;

You may not qualify if:

• 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;
• 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;
• 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 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.

Sponsors & Collaborators

• Mingzhi Zhang: lead

Study Sites (1)

Oncology Department of The First Affilliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Interventions

Decitabine; Rituximab; Prednisone

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Mingzhi Zhang, Doctor

CONTACT

13838565629; Mingzhi_zhang@126.com

Lei Zhang, Doctor

CONTACT

13525533696

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: the director of oncology department of the first affiliated hospital

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 12, 2024
• Study Start: November 20, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

CN (1)