Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma MedDRA version: 20.0 Level: LLT Classification code 10020328 Term: Hodgkin's lymphoma System Organ Class: 100000004864 MedDRA version: 20.1 Level: LLT Classification code 10065864 Term: Anaplastic large-cell lymphoma, primary systemic type System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Adcetris®
Product Name: Adcentris®
Product Code: SGN-35
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Brentuximab vedotin
CAS Number: 914088-09
Sponsors
Millennium Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 2 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. Patients meeting any of the following exclusion criteria are not to be enrolled in the study. If a patient is positive for ANY of the exclusion criteria, the patient will not be eligible for the study. 1. Current diagnosis of primary cutaneous ALCL (those with sALCL are eligible). 2. Received an allogeneic stem cell transplant < 3 months prior to first dose of study medication, or presence of polymerase chain reaction (PCR)-detectable CMV in any post-allogeneic transplant patient. (Prior PCR positivity that was successfully treated is acceptable provided the baseline PCR result is negative prior to first dose of study drug.) 3. Receiving immunosuppressive therapy. 4. Receiving systemic therapy for chronic graft-versus-host disease (topical therapy is allowed). 5. Previous treatment with any anti-CD30 antibody. 6. Therapeutic monoclonal antibody use within the longer of 6 weeks or 5 plasma half-lives. 7. Symptomatic cardiac disease including ventricular dysfunction, coronary artery disease, or arrhythmias, if this would, in the opinion of the investigator or medical monitor, interfere with assessment of efficacy or safety of the drug. 8. History of another primary malignancy not in remission for at least 3 years. (The following are exempt from the 3-year limit: nonmelanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear) 9. Known active cerebral/meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML) or any history of PML. 10. History of cirrhosis. 11. Active systemic viral, bacterial, or fungal infection requiring antimicrobial, antiviral therapy or antifungal therapy within 2 weeks prior to first dose of study drug (routine antimicrobial prophylaxis is acceptable). 12. Concurrent therapy with other anti-neoplastic or experimental agents. 13. Systemic corticosteroid therapy < 7 days prior to first dose of study medication. 14. Any serious underlying medical condition that, in the opinion of the investigator or medical monitor, would impair their ability to receive or tolerate the planned treatment. 15. Known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation. 16. Received nitrogen mustard agents, melphalan, or BCNU therapy within 6 weeks prior to first study dose. 17. Prior autologous hematopoietic stem cell infusion < 4 weeks prior to first study dose. 18. Grade 2 or greater unresolved toxicity from prior antineoplastic therapy. 19. Received a strong inhibitor of CYP3A4 < 2 weeks prior to first study dose. Please refer to the Study Manual for an example list of prohibited CYP3A4 inhibitors.) 20. Grade 2 or greater peripheral neuropathy. 21. Female patients who are both lactating and breastfeeding, or have a positive serum or urine pregnancy test during the screening period or a positive serum or urine pregnancy test on Day 1 before the first dose of study drug. 22. Received local palliative radiation therapy < 14 days prior to the first dose of study medication. 23. Received radiation therapy to more than 25% of the bone marrow-containing spaces < 84 days prior to first dose of study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 1: •To assess the safety profile and determine the pediatric maximum tolerated dose and/or recommended phase 2 dose of brentuximab vedotin •To assess the pharmacokinetics of brentuximab vedotin The primary objecives in Phase 2 include is: •To determine the overall response rate (complete remission, partial remission) with brentuximab vedotin at the recommended phase 2 dose;Secondary Objective: Phase 1 Secondary Objectives: The secondary objectives in phase 1 are: •To determine the immunogenicity of brentuximab vedotin •To determine the overall response rate (complete remission, partial remission) with brentuximab vedotin •To determine the time to progression, time to response, duration of response, and event-free, progression-free, and overall survival with brentuximab vedotin Phase 2 Secondary Objectives: The secondary objectives in phase 2 are: •To determine the time to progression, time to response, duration of response, and event-free, progression-free, and overall survival with brentuximab vedotin •To assess the pharmacokinetics and safety profile of brentuximab vedotin •To determine the immunogenicity of brentuximab vedotin Phase 2 Exploratory Objectives The exploratory objective in phase 2 is: •To assess immune reconstitution;Primary end point(s): Phase 1 Primary Endpoints: • Adverse events (AEs), serious adverse events (SAEs), assessments of clinical laboratory values, and vital sign measurements • Plasma concentrations of brentuximab vedotin, total therapeutic antibody, and MMAE Phase 2 Primary Endpoints: The primary endpoints in phase 2 include: • Best Overall response rate (CR, PR) as determined by an IRF using PET, CT, MRI and clinical assessment according to IWG revised response criteria ;Timepoint(s) of evaluation of this end point: Does not have a specific timepoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase 1 Secondary Endpoints: • Anti-therapeutic antibody (ATA) titer and neutralizing ATA titer •Best Overall response rate (CR, PR) as determined by an independent review facility (IRF) using positron emission tomography (PET), computed tomography (CT), magnetic resonance imaging (MRI), and clinical assessment, according to International Working Group (IWG) revised response criteria • Time to progression • Time to response • Duration of response • Event-free survival • Progression-free survival • Overall survival Phase 2 Secondary Endpoints: • Time to progression • Time to response • Duration of response • Event-free survival • Progression-free survival • Overall survival • Adverse events, serious adverse events, assessments of clinical laboratory values, and vital sign measurements • Plasma concentrations of brentuximab vedotin, total therapeutic antibody, and MMAE • Anti-therapeutic antibody (ATA) titer and neutralizing ATA titer;Timepoint(s) of evaluation of this end point: Does not have a specific timepoint. | — |
Countries
France, Germany, Italy, Mexico, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactDrug Information Call Centre
Millennium, Drug Information Call Center
Outcome results
None listed