Low grade B-cell lymphoma CD20 positive: -Marginal zone -Lymphocytic -Follicular
Conditions
Interventions
Trade Name: Zevalin
Product Name: Ibritumomab tiuxetan
Pharmaceutical Form: Kit for radiopharmaceutical preparation
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentr
Sponsors
GELA Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Aged from 18 to 65 years -patient with pathologically proven at relapse, low grade B-Cell lymphoma CD20+: Marginal zone or Lymphocytic or Follicular -In relapse after CR, less than PR o partial response (max 3 lines of treatment) -Previously treated with or without chemotherapy regimen containing rituximab -With chemo-sensitive disease using salvage therapy -Eligible for autologous stem cell transplantation -With a minimum life expectancy of 3 months -Negative HIV, HBV and HCV serologies -signed informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=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 -Prior transplantation -Contraindication to any drug contained in the chemotherapy regimens -Large bonne marrow irradiation> 40% -Bone marrow infiltration > 25% -Lack of suffiscient autologous stem cell transplantation -Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study -Ay serious active disease or co-morbid medical condition -Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100G/l, unless related to bone marrow infiltration -Poor renal function -Poor hepatic function -Any history of cancer during the last 5 years -Presence of anti-murine antibody (HAMA) reactivity -Known hypersensitivity to murine antibodies or proteins -Pregnant woman -Adult patient unable to give informed consent because of intellectual impairement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and the safety of a new preparative regimen for patients with low grade B-Cell lymphoma utilizing standard dose Yttrium-90 Ibritumomab Tiuxetan(Zevalin) radioimmunotherapy combined with high dose BEAM followed by ASCT;Secondary Objective: -Overall response rate (ORR) 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 analyse biological factors of the patients and their tumoirs 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 after treatment and changes of therapy | — |
Countries
Belgium
Outcome results
None listed