Diffuse Large B-Cell Lymphoma (DLBCL). Diffuse large B-cell lymphoma
Conditions
Interventions
Intervention 1: Intervention group: Six cycles of chemotherapy with the R CHOP regimen administered every three weeks. Rituximab manufactured by Zistdaru Danesh (single use vial, 100 mg/10 mL) will be
vincristine 1.4 mg/m² IV (maximum 2 mg) on Day 1 or 2 of each cycle
cyclophosphamide 750 mg/m² IV on Day 1 or 2 of each cycle
prednisone 40 mg/m² orally on Days 1 to 5 of each cycle. For patients aged 70 to 75 years: doxorubicin 25 mg/m² IV on Day 1 or 2 of each cycle
vincristine 1 mg/m² IV (maximum 2 mg) on Day 1 or 2 of each cycle
cyclophosphamide 400 mg/m² IV on Day 1 or 2 of each cycle
prednisone 40 mg/m² orally on Days 1 to 5 of each cycle. For the first rituximab infusion, the recommended initial rate is 50 mg/hour
after the first 30 minutes, the rate may be increased by 50 mg/hour every 30 minutes up to a maximum of 400 mg/hour. For subsequent infusions, the initial rate may be 100 mg/hour, with increments of 1
Sponsors
Zistdaru Danesh Co.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients aged 18 to 75 years Newly diagnosed patients with pathologically confirmed CD20-positive DLBCL non-Hodgkin lymphoma according to WHO criteria Presence of at least one measurable lesion on CT imaging, according to RECIST 1.1 Stage II, III, or IV disease as determined by the referring physician based on the Cotswolds modification of the Ann Arbor classification ECOG performance status = 2 Signed the informed consent form
Exclusion criteria
Exclusion criteria: Indolent lymphoma Primary central nervous system (CNS) Lymphoma Gastro-intestinal Mucosa Associated Lymphoid Tissue (MALT) Lymphoma Double-hit or Triple hit or Double Expressor lymphoma Diffuse Large B-cell lymphoma stage I Post-transplant lymphoproliferative disorder (PTLD) of the DLBCL subtype History of prior malignancy LVEF < 50% Patients with central nervous system (CNS) involvement (related to lymphoma) Uncontrolled active infection requiring systemic antibiotic or antiviral therapy at the time of the screening visit HIV-positive patients Known hypersensitivity to the active ingredients, excipients, murine proteins, or other foreign proteins included in the treatment regimen Concurrent disease or clinical condition that, in the investigator’s judgment, would preclude protocol-specified treatment Severe psychiatric illness that may interfere with treatment compliance Pregnant or breastfeeding women Women who intend to become pregnant during the study or within 18 months after its completion Men who intend to father a child during the study or within 10 months after its completion Treatment with any investigational product within 30 days prior to study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (complete response (CR) or partial response (PR) according to IWG) at the end of Cycle 6 of chemotherapy. Timepoint: After Cycle 6 of chemotherapy; at Study Week 22 (±14 days). Method of measurement: Imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate (complete response (CR) or partial response (PR) according to IWG) after Cycle 3 of chemotherapy. Timepoint: 10 to 15 days after Cycle 3 of chemotherapy. Method of measurement: Imaging.;Safety outcome. Timepoint: During infusion, throughout the study, and up to 30 days after receiving the last dose of the drug. Method of measurement: Safety will be evaluated based on side effect reports, laboratory test results, and vital signs measurements. Adverse events will be evaluated according to the National Cancer Institute CTC AE guidelines (v.5.0), which are grade 1 mild, moderate grade 2, severe grade 3, and life-threatening grade 4.;Immunogenicity outcome assessed by anti-drug antibody measurement in a subset of 40 patients. Timepoint: Before initiation of Cycle 1 and at the end of Cycles 3 and 6. Method of measurement: Laboratory test. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Niloofar Abiri
Zistdaru Danesh Co.
Outcome results
None listed