E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsed or Refractory Classic Systemic or Primary Cutaneous Anaplastic Large Cell Lymphoma (ALCL) |
|
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 |
To determine the objective response rate at Day 50 in patients with relapsed or refractory classic systemic anaplastic large cell lymphoma (csALCL) or primary cutaneous anaplastic large cell lymphoma (pcALCL) treated with MDX-060. |
|
E.2.2 | Secondary objectives of the trial |
1. Characterize progression-free survival 2. Determine response duration 3. Characterize the effect of MDX-060 on health-related Quality of Life 4. Evaluate patients with pcALCL using an adaptation of the NCI Response Criteria for Non-Hodgkin's Lymphoma (NHL) 5. Characterize the immunogenicity of MDX-060 6. Characterize the safety of MDX-060 7. Determine the best objective response rate during the Maintenance Phase of the study |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient or guardian must have read, understood, and provided written informed consent after the nature of the study has been fully explained. Patients 12 through 17 years old must also provide written assent 2. Confirmed diagnosis of ALCL (excluding HIV-associated ALCL) 3. Patients with csALCL must have a histologically confirmed diagnosis of CD30+ ALCL and confirmation of anaplastic lymphoma kinase status (positive or negative) 4. Patients with csALCL must have failed or relapsed following second line chemotherapy or relapsed or failed following autolougus stem cell transplant. Patients who are not candidates for stem cell transplant, exhibitit chemo-resistant disease, or refuse further chemotherapy may also be included. 5. Patients with pcALCL must have progressed after treatment with local radiation therapy or surgical excision or failed systemic therapy with a single agent or multi-agent regimen 6. Patients with pcALCL must have a histologically confirmed diagnosis of CD30+ ALCL within the past 12 months 7. ECOG Performance Status of 0 to 2 8. Patients must have bidirectionally measurable disease 9. At least 4 weeks since the last chemotherapy or radiation therapy prior to dosing of MDX-060 and have recovered from any toxicity associated with such treatment or returned to baseline 10. At lease 12 years of age 11. Life expectancy of 12 weeks or more 12. Screening laboratory valuse must meet criteria 13. Women must either be post-menopausal for at least 1 year, surgically incapable of bearing children, or utilizing a reliable form of contraception. All women must have a negative pregnancy test during screening 14. Men must agree to the use of male contraception for the duration of the study 15. Patients on corticosteroids must be tapered off the medication 2 weeks prior to the first MDX-060 administration and remain off corticosteroids until Day 365 |
|
E.4 | Principal exclusion criteria |
1. Previous treatment with any anti-CD30 antibody 2. History of allogenic transplantation 3. Any tumor lesion 10cm or greater in diameter 4. Any other malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the patient has been disease-free for at least 5 years is permissible 5. Any significant active or chronic infection 6. Prior known serum positivity for HIV antibodies, hepatitis B antigenemia, or hepatitis C veremia, as determined at screening 7. Treatment with investigational agent within 30 days or 5 half-lives (whichever is longer) of study screening 8. Apparent active or latent tuberculosis infection 9. Patients who are pregnant or nursing 10. Any underlying medical condition which, in the Principal Investigator's opinion, will make the administration of MDX-060 hazardous or obscure the interpretation of adverse events 11. Concomitant chemotherapy, corticosteroids, investigational agents, other anti-ALCL biologics, or radiation therapy 12. Patients with mycosis fungoides 13. Patients with recurrent, self-healing papulonodular eruptions only or any other lymphoma other than ALCL |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Objective response rate at Day 50 as based on an adaptation of the NCI Response Criteria for Non-Hodgkin's Lymphoma (NHL) for patients with csALCL and will be based on the Physician's Global Assessment (PGA) for patients with pcALCL. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
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.8.3 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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 |
|
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
|
The study will terminate 1 year after the last patient has recieved the last dose of MDX-060 or when all patients have progressed and are off study, whichever is earlier. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |