In this trial patients with advanced indolent and aggressive lymphoma are included.
Conditions
Interventions
Product Name: 90Yttrium-Ibritumomab Tiuxetan
Pharmaceutical Form: Intravenous infusion
Sponsors
Medizinische Universitätsklinik II , Abteilung Hämatologie, Onkologie, Immunologie und Rheumatologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Arm A: 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) - Splenic Arm B: Following lymphoma entities can be included in Arm B of the protocol: - Diffuse large B-cell lymphoma/Follicular lymphoma grade 3 - Grade 3 follicular lymphoma - Blastic mantle cell lymphoma - Mediastinal B-cell lymphoma - Age >18, 60% - HLA-identical related- or unrelated donor - CD20+ lymphoma cells on biopsy or peripheral blood - Disease Stage at inclusion: CR, PR or SD 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 2x upper limit of normal. - Chronic active viral hepatitis - Ejectionfraction grade II hypertension by CTC criteria - Creatinine clearance <50 ml/min - Respiratory failure necessitating supplemental oxygen or DLCO <30% - Allergy against murine antibodies - HIV-Infection - Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control during study treatment and for at least 12 months thereafter. (Women of childbearing potential must have a negative serum pregnancy test at study entry) - Patients with pleural effusion or ascites - Concurrent severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study - Patients who received any investigational drugs less than 4 weeks before entry in this study or who have not as yet recovered from the toxic effects of such therapy - Patients who underwent surgery within 4 weeks of entering the study or patients who have not as yet recovered from the side-effects of such treatment - Patients with a history of psychiatric illness or condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction) - Patients unwilling or unable to comply with the protocol - Unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this protocol are to evaluate treatment related toxicity and engraftment after nonmyeloablative conditioning including radioimmunotherapy with 90Y-ibritumomab tiuxetan. Toxicity will be assessed according to CTC criteria. Furthermore we will evaluate the therapy related mortality and morbidity. ;Secondary Objective: Secondary objectives are: - Evaluation of disease response, relapse rate and disease free and overall survival - Evaluation of the incidence and severity of graft versus host disease (GVHD) - Evaluation of immunreconstitution after HCT ;Primary end point(s): The study will be stopped if the rate of graft failure or non-engraftment exceeds 30% or the rate of treatment related mortality exceeds 40%. If the rejection rate or TRM is lower the study will be continued for another 10 patients in each arm. | — |
Countries
Germany
Outcome results
None listed