Diffuse Large B cell Lymphoma MedDRA version: 9.1 Level: LLT Classification code 10012818 Term: Diffuse large B-cell lymphoma
Conditions
Interventions
Trade Name: ZEVALIN
Product Name: Ibritumomab tiuxetan
Pharmaceutical Form: Kit for radiopharmaceutical preparation
INN or Proposed INN: ibritumomab tiuxétan
Concentration unit: mg/ml milligram(s)/mi
Sponsors
GELA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Aged from 18 to 65 years, -Patient with pathologically proven large B-Cell lymphoma CD20 positive (WHO classification):Diffuse large B cell lymphoma, Adverse prognostic factors: IPI >1. -In CR, or partial response to first line treatment, -Treated with first line chemotherapy regimen containing rituximab, R CHOP like or R ACVBP -Chemo-sensitive disease - PET scan before transplant -Eligible for autologous stem cell transplantation, -ECOG performance status 0 to 2, -With a minimum life expectancy of 3 months, -Negative HIV, HBV and HCV serologies =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Histological transformation in diffuse large cell from a low grade B-Cell lymphoma, Any type of low grade lymphoma -Prior transplantation, Prior exposure to Zevalin - Contraindication to any drug contained in the chemotherapy regimens, - Large bone marrow irradiation > 40%, -Bone marrow infiltration -Lack of sufficient autologous hematopoietic stem cells for transplantation, -Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study, -Any serious active disease or co-morbid medical condition (according to the investigator’s decision and information provided in the IDB), -Poor bone marrow reserve as defined by neutrophils 2.5 maximum normal level) unless these abnormalities are related to the lymphoma, -Poor hepatic function (total bilirubin level > 30 µmol/l,, transaminases > 2.5 maximum normal level) unless these abnormalities are related to the lymphoma, -Central nervous system or meningeal involvement by lymphoma, -Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma, -Prior treatment with murine antibodies -Known hypersensitivity to murine antibodies or proteins, -Pregnant woman, -Adult patient unable to give informed consent because of intellectual impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and the safety of a preparative regimen utilizing standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy combined with high-dose BEAM followed by ASCT after first line treatment in patients aged from 18 to 65 years with poor prognosis CD 20 Diffuse Large B-Cell lymphoma PRIMARY ENDPOINT: Event free survival (EFS) at 2 years: events being death from any cause, relapse for complete responders and unconfirmed complete responders, progression during and after treatment and changes of therapy.;Secondary Objective: SECONDARY ENDPOINTS - Overall response rate (ORR) (complete response CR and partial response PR) at day 100 after ASCT. - Toxicities, transplant related mortality at 1 and 2 years. - Hematological reconstitution after ASCT and at 1 year. - Time to progression or relapse, disease-free survival for complete responders after ASCT, overall survival. - To analyze biological factors of the patients and their tumors that influence treatment response and prognosis. ;Primary end point(s): Event free survival (EFS) at 2 years: events being death from any cause, relapse for complete responders and unconfirmed complete responders, progression during and after treatment and changes of therapy. | — |
Countries
Belgium
Outcome results
None listed