Multicenter Phase I/II Study of Radioimmunotherapy With 90Y-ibritumomab Tiuxetan in a Nonmyeloablative Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation From HLA-identical Donors in Patients With Advanced Non-Hodgkin Lymphoma

University Hospital Tuebingen11 sites in 1 country60 target enrollmentMarch 2006

ConditionsNon-Hodgkin Lymphoma

DrugsRadioimmunotherapy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Non-Hodgkin Lymphoma
Sponsor: University Hospital Tuebingen
Enrollment: 60
Locations: 11
Primary Endpoint: treatment related toxicity
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study evaluates the additional use of radioimmunotherapy with a 90-Yttrium labeled monoclonal antibody targeting lymphoma cells in two dose reduced conditioning regimens for allogeneic hematopoietic cell transplantation from human leukocyte antigen (HLA)-identical donors. Radioimmunotherapy should allow an increased anti-lymphoma effect of the conditioning while the allogeneic grafts may confer potent graft versus lymphoma effects and rescue from potential hematopoietic side effects of the radioimmunotherapy. The study evaluates the feasibility and toxicity of such approach and will also analyze disease response and survival of the patients treated.

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

July 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital Tuebingen

Eligibility Criteria

Inclusion Criteria

•Patients with advanced CD20+ NHL (non-Hodgkin lymphoma) relapsed after at least two preceding chemotherapy regimens including treatment with rituximab or with relapse after autologous HCT (hematopoietic cell transplantation)
•The following entities of lymphomas can be included in Arm A of the protocol:
•Small lymphocytic lymphoma (SLL/CLL)
•Mantle cell lymphoma (MCL)
•Follicular lymphoma Grade 1-2
•Marginal zone lymphoma (MZL)
•Extranodal (MALT lymphoma)
•Nodal (Monocytoid B-cell lymphoma)
•The following lymphoma entities can be included in Arm B of the protocol:
•Diffuse large B-cell lymphoma/follicular lymphoma grade 3

Exclusion Criteria

•Patients with rapidly progressive disease
•Less than 3 months after preceding HCT
•CNS involvement with disease
•Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month
•Liver function abnormalities with bilirubin \> 2 mg/dL and elevation of transaminases higher than 2x upper limit of normal
•Chronic active viral hepatitis
•Ejection fraction \< 40% on echocardiography
•Patients with \> grade II hypertension by CTC criteria
•Creatinine clearance \< 50 ml/min
•Respiratory failure necessitating supplemental oxygen or DLCO \< 30%