Reduced intensity conditioning with high-dose rituximab followed by allogeneic transplantation of hematopoietic cells for the treatment of relapsed/refractory B-cell non Hodgkin?s lymphomas - ND

Phase 1

• Conditions: B-cell non-Hodgkin lymphomas; MedDRA version: 9.1Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cell

• Registration Number: EUCTR2007-003657-87-IT
• Lead Sponsor: ISTITUTO NAZIONALE PER LA CURA TUMORI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-12
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

1. Age ≥ 18 ≤ 65 years 2. Histologies as follow: 2a.Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) relapsing after at least 2 lines of conventional chemotherapy or relapsing after a first line (within one year) including purine analogue-based regimen or relapsing after autologous stem cell transplantation (as first or second line) 2b. Primary refractory CLL or SLL 2c.Follicular lymphomas (FCL) relapsing after 2 lines or relapsing after autologous stem cell transplantation 2d.Primary refractory FCL 2e.Mantle cell lymphomas (MCL) relapsing after conventional chemotherapy or autologous stem cell transplantation 2f.Diffuse large B-cell lymphomas (DLBCL) or transformed FCL relapsing after two lines of conventional chemotherapy or autologous stem cell transplantation 2g.CLL, FCL, MCL and DLBCL considered eligible for high-dose chemotherapy, with a positive bone marrow biopsy or collecting PCR positive harvests before the autografting phase 3. PS (Karnofsky)  70% 4. HLA-identical (A, B, C, DR, DQ loci) or one antigen mismatched (class I) sibling donors 5. Written informed consent
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

1. Central nervous system localization 2. Positive serologic markers for human immunodeficiency virus (HIV) 3. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection 4. Serum bilirubin levels > 2 the upper normal limit 5. Ejection fraction < 45% (or myocardial stroke in the last year) 6. Clearance of creatinine < 50 ml/min 7. DLCO < 50% 8. Pregnancy or lactation 9. Patient not agreeing to take adequate contraceptive measures during the study 10. Psychiatric disease 11. Any active, uncontrolled infection 12. Type I hypersensivity or anaphylactic reactions to rituximab

Study & Design

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