E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with diffuse Large B-Cell lymphoma, CD20-positive |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012820 |
E.1.2 | Term | Diffuse large B-cell lymphoma NOS |
|
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 objective of this study is to evaluate the conversion rate from PET-positive to PET-negative residual masses after 90Y-ibritumomab tiuxetan treatment in patients with PET-positive partial remission following first-line R-CHOP chemotherapy. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the progression-free survival, the overall survival (OS) and the toxicity of DLBCL-patients with PET-positive partial remission treated with 90Y-ibritumomab tiuxetan. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Age ≥ 60 years old -WHO performance status of 0-2 (see Appendix E) -Life expectancy of at least 3 months -Histologically confirmed CD20 positive Diffuse large B-cell lymphoma (DLBCL), according to the WHO classification (see Appendix B) -First-line induction treatment with R-CHOP or R-CHOP-like chemotherapy (only CHOP in combination with rituximab; CHOP14 and CHOP21 are both allowed) -Partial response on CT-scans after first-line treatment, with measurable disease -PET-positive residual mass -Patient is not eligible for high dose chemotherapy followed by autologous stem cell transplantation -Less than 25% bone marrow involvement at the end of first-line treatment during PR analysis (measurement in a representative bone marrow biopsy) -Absolute neutrophil count (ANC) ≥ 1.5 x 109/l -Hemoglobin (Hb) ≥ 6 mmol/l -Platelets ≥ 150 x 109/l -Written informed consent obtained according to local guidelines
|
|
E.4 | Principal exclusion criteria |
-Hypoplastic bone marrow at biopsy -Prolonged pancytopenia during induction chemotherapy and delayed courses during R-CHOP induction (more than two weeks delay due to insufficient bone marrow reserve) -Known hypersensitivity to murine antibodies or proteins -Significant splenomegaly -Patients with abnormal liver function (total bilirubin > 2.0 x ULN) -Patients with abnormal renal function (serum creatinine > 2.0 x ULN) -Presence of CNS involvement by NHL -Presence of any other active neoplasms or history of prior malignancy, except non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma during the past 5 years -More than one prior R-CHOP or R-CHOP-like chemotherapy regimen for DLBCL -Patients who have received prior external beam radiotherapy to > 25% of active bone marrow (involved field or regional) -Patients who have received G-CSF or GM-CSF therapy within two weeks prior to study enrollment -Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study -Patients who have received biologic therapy, immunotherapy, R-CHOP(-like) chemotherapy, surgery, or an investigational drugs less than 4 weeks prior to first day of study treatment or who have not recovered from the toxic effects of such therapy -Patients who have received systemic corticosteroids at doses higher than 20 mg/day prednisolone or equivalent less than 2 weeks prior to 90Y-ibritumomab tiuxetan administration -Known diagnosis of HIV infection -Patients unwilling or unable to comply with the protocol |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Complete response on FDG-PET (i.e. PET-negative residual masses) |
|
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 | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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 | No |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |