E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hodgkin lymphoma
Anaplastic large cell lymphoma
CD30-positive cutaneous T-cell lymphoma |
|
E.1.1.1 | Medical condition in easily understood language |
Hodgkin lymphoma
Anaplastic large cell lymphoma
CD30-positive cutaneous T-cell lymphoma |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020328 |
E.1.2 | Term | Hodgkin's lymphoma |
E.1.2 | System Organ Class | 100000004864 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011677 |
E.1.2 | Term | Cutaneous T-cell lymphoma |
E.1.2 | System Organ Class | 100000004864 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065864 |
E.1.2 | Term | Anaplastic large-cell lymphoma, primary systemic type |
E.1.2 | System Organ Class | 100000004864 |
|
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 |
• To provide the option of treatment with brentuximab vedotin for patients in study SGN35-005 who experience progression of Hodgkin lymphoma (HL), and for those patients in study C25001 on the experimental arm with an objective response at the time of discontinuation of brentuximab vedotin or the control arm who experience progression of CD30-positive (CD30+) cutaneous T-cell lymphoma (CTCL) per independent review facility (IRF).
• To assess the safety and tolerability of brentuximab vedotin
• In the US only, to provide access to brentuximab vedotin for patients with relapsed or refractory HL and patients with relapsed or refractory anaplastic large cell lymphoma (ALCL)(Amendment 5 and later, not applicable). |
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E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Participated in the SGN35-005 clinical study and experienced progression of HL as defined by the SGN35-005 study protocol.
Or,
Patients who met all Inclusion/Exclusion criteria for the the C25001 clinical study, and experienced disease progression per IRF: patients on he control arm or patients on the experimental arm with an objective response at the time of discontinuation of brentuximab vedotin.
Or in the US only; Patients with relapsed or refractory HL or patients with relapsed or refractory systemic ALCL who have previously failed frontline chemotherapy and documented anaplastic lymphoma kinase(ALK) status (Amendment 5 and later, not applicable).
-Completed any previous treatment with radiation, chemotherapy,
biologics and/or investigational agents at least 4 weeks prior to the first dose of brentuximab vedotin unless underlying disease is progressing on therapy
|
|
E.4 | Principal exclusion criteria |
-History of another primary malignancy that has not been in remission
for at least 3 years
-Known cerebral/meningeal disease
-Peripheral neuropathy of grade 2 or greater
- Females who are pregnant or lactating
-Patients who are eligible to participate in other brentuximab vedotin clinical studies(Amendment 5 and later, not applicable)
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The safety endpoints are the type, incidence, severity, seriousness, and study drug relatedness of adverse events (AEs). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From study enrolment through 1 month after each patient's last dose. |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | 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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 27 |
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 | No |
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 |
Australia |
Belgium |
Bulgaria |
France |
Germany |
Hungary |
Italy |
Poland |
Romania |
Russian Federation |
Serbia |
Spain |
Switzerland |
United Kingdom |
United States |
|
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 | 7 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |