E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Systemic anaplastic large cell lymphoma (ALCL) |
|
E.1.1.1 | Medical condition in easily understood language |
Systemic anaplastic large 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 | 14.1 |
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 |
The main objective of this trial is to determine the antitumor efficacy of single-agent SGN-35 (1.8 mg/kg administered intravenously every 3 weeks), as measured by the overall objective response rate in patients with relapsed or refractory systemic anaplastic large cell lymphoma following front-line chemotherapy (CHOP or equivalent). |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are the following: • To assess duration of tumor control, including duration of response and progression-free survival (PFS) • To assess survival • To assess the safety and tolerability of SGN-35 • To assess the pharmacokinetics of SGN-35
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Patients with relapsed or refractory systemic ALCL (anaplastic large cell lymphoma) who have previously received front line chemotherapy. • Documented anaplastic lymphoma kinase (ALK) status. • Histologically-confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block. • Fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm as documented by both PET and spiral CT. • Received any previous ASCT (autologous stem cell transplant) at least 12 weeks (3 months) prior.
• At US sites patients greater than or equal to 12 years of age may be enrolled. At non-US sites patients must be greater than or equal to 18 years of age |
|
E.4 | Principal exclusion criteria |
• Previous treatment with SGN-35. • Previously received an allogeneic transplant. • Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible). • Known cerebral/meningeal disease. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of this study is the overall objective response rate (ORR) per an independent review facility (IRF). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
The secondary endpoints are: • Duration of response per IRF • Complete remission (CR) rate per IRF • Progression-free survival (PFS) per IRF • Overall survival (OS) • Type, incidence, severity, seriousness, and relatedness of adverse events, and laboratory abnormalities • Population estimates of selected pharmacokinetic parameters |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
• Duration of response, progression-free survival, and overall survival: Every 3 months until death or study closure • Complete remission (CR) rate per IRF: Every 2 to 3 months • Incidence of adverse events and laboratory abnormalities: Through 1 month following last dose • Population estimates of selected pharmacokinetic parameters: Every 2-3 weeks
|
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | Information not present in EudraCT |
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.8.4.1 | 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 | 14 |
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 |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
The end of the trial will be the date of final clinical database lock of the trial. It is anticipated that this will occur 60 months after the last patient completes receiving study medication. Patients will be followed for long-term survival data to assess one of the secondary endpoints, but none of these patients will be on study medication. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
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 | 5 |
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 |