Targeted Intensification by a new preparative regimen for patients with Low-Grade B-Cell Lymphoma utilizing standard dose Ytrium 90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy (RIT) combined with high dose BEAM followed by autologous stem cell transplantation (ASCT) - Z-BEAM

Phase 1

• Conditions: ow grade B-cell lymphoma CD20 positive:-Marginal zone-Lymphocytic-Follicular

• Registration Number: EUCTR2004-004349-16-BE
• Lead Sponsor: GELA Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-31
• Study Completion: 2009-03-01
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified