EUCTR2005-002206-37-DEActive, not recruitingNot Applicable
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
Medizinische Universitätsklinik II , Abteilung Hämatologie, Onkologie, Immunologie und Rheumatologie0 sites40 target enrollmentStarted: September 27, 2005Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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)
- •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, <70 years
- •- Karnofsky score >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
- •- 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 <40 % on echocardiography
- •- Patients with > 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
Investigators
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