Lymphoma, Large B-Cell, Diffuse
Conditions
Keywords
bulky diffuse large B cell lymphoma, 90Y-ibritumomab tiuxetan, clinical response, Safety and toxicity
Brief summary
This phase II study is aimed at the clinical efficacy and toxicity of 6th R-CHOP chemotherapy followed by ibritumomab tiuxetan (Zevalin) consolidation in patients with limited-stage, bulky diffuse large B cell lymphoma (DLBCL).
Detailed description
The patients with limited-stage, bulky diffuse large B cell lymphoma (DLBCL) are known to have a poor prognosis as like to those with advanced disease. However, there are very limited studies to compare the clinical outcome of therapy after chemotherapy only with combined modality using radiation. Defining local failure at bulky sites as one component of relapse, radioimmuotherapy appears to reduce the failure rates at previous bulky sites. We assessed the clinical efficacy and toxicity of 6th R-CHOP chemotherapy and followed by ibritumomab tiuxetan (Zevalin) consolidation in patients with limited-stage, bulky DLBCL.
Interventions
During Zevalin treatment, rituximab 250 mg/m2 will be administered with the same methods mentioned above on days 1 and 8. On day 8, within 4 hours following completion of the rituximab dose, 90Y Zevalin at a dose of 0.4 mCi/kg actual body weight for patients with a platelet count \> 150,000/L and 0.3 mCi/kg actual body weight for patients with a platelet count of 100,000 - 149,000/L will be injected intravenously over a period of 10 minutes. The maximum allowable dose of 90Y Zevalin is 32 mCi regardless of the patient's body weight. 90Y Zevalin should be administered within 4 hours after radiolabeling of Zevalin with 90Y.
Sponsors
Samsung Medical Center
Asan Medical Center
Chonbuk National University Hospital
Dong-A University Hospital
Pusan National University Hospital
Severance Hospital
Chonnam National University Hospital
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
* Newly diagnosed CD20+ DLBCL * Patients with stage I/II * Bulky disease defined by maximum diameter greater than 10 cm or any mediastinal mass exceeding 1/3 the maximum trans- thoracic diameter (more than 8 cm) * Patients that achieved a complete (CR) or partial response (PR) after 6th R-CHOP chemotherapy * Aged over 18 years * ECOG performance status 0-2.
Exclusion criteria
* Previous history of chemotherapy for diffuse large B cell lymphoma * Prior myeloablative therapy * Prior external-beam radiation to \>25% of active bone marrow * Pregnancy and lactation * \>25% bone marrow infiltration * Platelet counts \<100 000/µl, neutrophil counts \<1500/µl * Children and adolescents under 18 years of age * Presence of CNS involvement with diffuse large B cell lymphoma * Positive HIV serology * Seriously uncontrolled, current infections or other concomitant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response | Up to 24 weeks after the infustion of 90Y-ibritumomab tiuxetan | Patients receive six cycles of R-CHOP chemotherapy per 21-day intervals. Patients with clearly documented progressive disease will be taken off the study when progression is noted. Patients who achieved a complete or partial response after 6th R-CHOP chemotherapy will receive ibritumomab tiuxetan treatment as a consolidation. |
| Safety and toxicity | 3 years after the infusion of 90Y-ibritumomab tiuxetan | After Zevalin treatment, safety profiles will be evaluated with physical examination, vital signs, performance status, serum chemistry and electrolytes, and lymphocytes subset using NCI Common Terminology Criteria for Adverse Events version 3.0, every 4 weeks for 6 months, and then every 3 months for the next 6 months. |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | the time from start of R-CHOP to the first recording of disease progression or death of any cause |
Countries
South Korea
Outcome results
None listed