E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
In this trial patients with advanced indolent and aggressive lymphoma are included. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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, <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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |