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
- Conditions
- In this trial patients with advanced indolent and aggressive lymphoma are included.
- Registration Number
- EUCTR2005-002206-37-DE
- Lead Sponsor
- Medizinische Universitätsklinik II , Abteilung Hämatologie, Onkologie, Immunologie und Rheumatologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 40
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, <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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method