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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003657-87-IT

Enrollment

190

Registered

2008-02-12

Start date

2007-09-14

Completion date

Unknown

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-cell non-Hodgkin lymphomas MedDRA version: 9.1 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell

Interventions

Trade Name: MABTHERA Pharmaceutical Form: Solution for infusion INN or Proposed INN: Rituximab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Progression-free survival at one year;Secondary Objective: Overall survival Engraftment Incidence of acute graft-versus-host disease (aGVHD) Incidence of chronic graft-versus-host disease (cGVHD) Nonrelapse mortality at one year Percentage of molecular remissions at one year for patient having a molecular marker;Primary end point(s): Progression free survival	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026