Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Conditions
Brief summary
In patients with relapsed or refractory diffuse DLBCL who have not achieved complete remission in the mid-term, the treatment with Glofit+GemOx regimen is used.
Detailed description
Efficacy and Safety of Glofitamab Combined with GemOx (Gemcitabine and Oxaliplatin) in the Treatment of Refractory Diffuse Large B-Cell Lymphoma.
Interventions
DRUGGlofitamab
On Day 1 of Cycle 1 (7 days before the first administration of Glofitamab), a single intravenous dose of 1000 mg of Obinutuzumab was administered. Then, in Cycle 1 (Day 8: 2.5 mg; Day 15: 10 mg), Glofitamab was administered intravenously with gradually increasing doses, followed by a fixed dose of 30 mg of Glofitamab on Day 1 of Cycles 2 to 6. GemOx treatment (intravenous Gemcitabine 1000 mg/m² and Oxaliplatin 100 mg/m², administered on Day 2 of Cycle 1 and then on Day 1 of subsequent cycles) was given every 21 days per cycle.
DRUGGemcitabin
On Day 1 of Cycle 1 (7 days before the first administration of Glofitamab), a single intravenous dose of 1000 mg of Obinutuzumab was administered. Then, in Cycle 1 (Day 8: 2.5 mg; Day 15: 10 mg), Glofitamab was administered intravenously with gradually increasing doses, followed by a fixed dose of 30 mg of Glofitamab on Day 1 of Cycles 2 to 6. GemOx treatment (intravenous Gemcitabine 1000 mg/m² and Oxaliplatin 100 mg/m², administered on Day 2 of Cycle 1 and then on Day 1 of subsequent cycles) was given every 21 days per cycle.
DRUGOxaliplatin
On Day 1 of Cycle 1 (7 days before the first administration of Glofitamab), a single intravenous dose of 1000 mg of Obinutuzumab was administered. Then, in Cycle 1 (Day 8: 2.5 mg; Day 15: 10 mg), Glofitamab was administered intravenously with gradually increasing doses, followed by a fixed dose of 30 mg of Glofitamab on Day 1 of Cycles 2 to 6. GemOx treatment (intravenous Gemcitabine 1000 mg/m² and Oxaliplatin 100 mg/m², administered on Day 2 of Cycle 1 and then on Day 1 of subsequent cycles) was given every 21 days per cycle.
DRUGObinutuzumab
On Day 1 of Cycle 1 (7 days before the first administration of Glofitamab), a single intravenous dose of 1000 mg of Obinutuzumab was administered. Then, in Cycle 1 (Day 8: 2.5 mg; Day 15: 10 mg), Glofitamab was administered intravenously with gradually increasing doses, followed by a fixed dose of 30 mg of Glofitamab on Day 1 of Cycles 2 to 6. GemOx treatment (intravenous Gemcitabine 1000 mg/m² and Oxaliplatin 100 mg/m², administered on Day 2 of Cycle 1 and then on Day 1 of subsequent cycles) was given every 21 days per cycle.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years; * DLBCL confirmed by pathological diagnosis according to the WHO 2016 classification; * PET-positive (Deauville score 4-5) according to Lugano response criteria after 3 cycles of first-line treatment; * No history or evidence of central nervous system involvement; * Adverse reactions from prior treatments have recovered to grade 1 or below (excluding clinically insignificant reactions such as hair loss); * ECOG performance status score ≤ 2; * Adequate bone marrow, kidney, liver, respiratory, and cardiac function: absolute neutrophil count ≥ 1000/μL; platelet count ≥ 75,000/μL; absolute lymphocyte count ≥ 100/μL; creatinine clearance ≥ 60 mL/min; ALT and AST ≤ 2.5 times the upper limit of normal; total bilirubin ≤ 1.5 mg/dL (except for Gilbert's syndrome); cardiac echocardiography showing ejection fraction ≥ 50% with no pericardial effusion (small or physiological effusions excluded); no clinically significant serosal effusions; baseline oxygen saturation \> 92%; * The subject is able to understand the study protocol, is willing to participate in this study, and provides written informed consent.
Exclusion criteria
* History of malignant tumors, excluding non-melanoma skin cancers or carcinoma in situ (cervix, bladder, breast), unless the disease has been in remission for at least 3 years; * Uncontrolled fungal, bacterial, viral, or other infections requiring intravenous anti-infective therapy; * Human immunodeficiency virus (HIV) infection, or acute/chronic active hepatitis B or C infection; * Malignant cells detectable in cerebrospinal fluid or active CNS lymphoma; * History of myocardial infarction, coronary artery bypass graft, or stent implantation within 12 months prior to enrollment; * History of deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment; * Female patients who are pregnant or breastfeeding, as determined by the investigator; * Inability of the subject to complete the study protocol or visits; * Presence of uncontrollable infection; * Currently participating in interventional study treatment, or having received other investigational drugs within 4 weeks prior to first dose (previous treatment with cetuximab, oxaliplatin, and gemcitabine is included); * Any other condition that the investigator deems the patient unsuitable for this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate | From enrollment to the end of treatment at 8 weeks | Refers to the proportion of patients whose all detectable target lesions (such as tumor lesions or affected tissues) have completely disappeared after treatment with Glofitamab combined with GemOx, and this state lasts for at least 4 weeks. This condition needs to be confirmed through imaging examinations (such as CT, MRI, or PET-CT) and assessed comprehensively in combination with ctDNA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | From enrollment to the end of treatment at 8 weeks | The overall response rate (ORR) was defined as the cumulative proportion of patients attaining either a complete response (CR) or partial response (PR) . |
| OS | From enrollment to the end of treatment at 8 weeks | OS was measured from Golfitamab combined with GemOx initiation to death or last follow-up |
| PFS | From enrollment to the end of treatment at 8 weeks | PFS defined as the time from Glofitamab combined with GemOx initiation to first documented disease progression, relapse after Glofitamab combined with GemOx, death from any cause, or last follow-up. |
| DoR | From enrollment to the end of treatment at 8 weeks | It refers to the period of time from when a patient first achieves disease remission (such as tumor shrinkage reaching a certain percentage or significant improvement in symptoms) after receiving treatment, until the disease progresses again, relapses, or related adverse events (such as death) occur. |
Countries
China
Contacts
STUDY_CHAIRCao Xinxin
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed