E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mantle cell lymphoma is a non-Hodgkin lymphoma which is rare and holds a bad prognosis with no known curative therapies available. The lymphoma is most often disseminated at diagnosis. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of the third Nordic phase II trial in mantle cell lymhoma is to improve the failure-free survivial in pasients who are not in complete remission before transplant by including Zevalin radioimmuntherapy as part of the high-dose regimen before autologous stem cell support. |
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E.2.2 | Secondary objectives of the trial |
Evaluate safety by including Zevalin in the high-dose regimen Evaluate FFS in patients who are in CR before transplant and thus not receiving Zevalin Evaluate OS in all both patient groups Evaluate TTF in both patient groups Evaluate TTP in both patient groups Evaluate response rates Evaluate molecular response rates Evaluate molecular response and progression-free survival in patients who become PCR positive in bone marrow post-transplant and receive treatment with Rituximab Evaluate lymphoma tissue gene expression profiles and correlate this to outcome |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Histologically and immunhistologically defined diagnosis of mantle cell lymphoma Previously untreated, except one course of any regimen 18-65 years of age WHO performance status 0-3 Written informed consent |
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E.4 | Principal exclusion criteria |
Previously treated for lymphoma Severe medical conditions or infections Pregnancy Other malignancies in the past Severe psyciatric disorders Unwilling or anable to comply with the protocol |
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to treatment failure for pasients receiving not in complete remission prior to transplant and thus receiving Zevalin in addition to the high-dose chemotherapy regimen. A comparisom is to be made to patients included in the previous phase II study, where patients received identical treatment, but without Zevalin. 150 patients have been included in the previoous trial. |
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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 | No |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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When the last patient has been followed for 5 years post-transplant |
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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 | 9 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 9 |