E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mantle cell lymphoma is a rare non-Hodgkin lymphoma (5%) with a bad prognosis with no curative therapies available at present. The disease is most often widely 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 with the third Nordic phase II trial in mantle cell lymphoma is to improve the failure-free survival in patients who are not in complete remission before high dose chemotherapy by including Zevalin radioimmunotherapy 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 and toxicity by including Zevalin in the high dose regimen. Evaluate failure-free survival in patients in complete remission before transplant. Evaluate overall survival, time to treatment failure and and time to progression. Evaluate response rate and molecular response rate before and after high dose treatment. Evaluate molceluar response and progression-free survival time in patients who are PCR+ post transplant( with increasing signal) or convert to PCR+ in the bone marrow during follow up and then recieve 4 weekly doses of rituximab. Evaluate lymphoma tissue gene expression by microarray analysis as a tool to predict 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 immunohistochemically defined diagnos 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. History of other malignancies. Severe psychiatric disorders. Unwilling or unable 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 patients recieiving Zevalin in addition to high dose chemotherapy. A comparision is to be made to patients included in the previous Nordic Mantle Cell Lymphoma phase II study comprising 150 patients. |
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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 | 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 |