Relapsed or Refractory Hodgkin Lymphoma MedDRA version: 18.0 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Sponsors
Millennium Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patients 18 years or older. A diagnosis of relapsed or refractory classical HL, confirmed by biopsy if clinically feasible on the basis of local pathology review. A history of at least 1 prior systemic chemotherapeutic regimen. Not suitable for SCT or multiagent chemotherapy Bidimensional measurable disease, of at least 1.5 cm, as documented by radiographic technique (spiral CT scan preferred), per IWG Revised Response Criteria for Malignant Lymphoma. Patients must have completed any prior immunotherapy (eg, rituximab) or radioisotopic therapy at least 12 weeks before the first dose of brentuximab vedotin in the absence of clear disease progression. Patient has recovered to Grade 1 or lower toxicity related to radiotherapy, immunotherapy, and chemotherapy unless evidence of toxicity is due to underlying HL. If toxicity is related to underlying HL, Grade 2 or lower toxicity is acceptable Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Previous treatment with brentuximab vedotin. 2. Previously received an ASCT or alloSCT. 3. Female patients who are 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 first dose of study drug. 4. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol. 5. Treatment with any investigational products within 4 weeks before the first dose of study drug. 6. Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug: - New York Heart Association Class III or IV heart failure (refer to Section 15.3) - Myocardial infarction within 6 months before the first dose of study drug - Evidence of current uncontrolled cardiovascular conditions, including clinically relevant cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities 7. History of another primary malignancy that has not been in remission for at least 3 years. (The following are exempt from the 3-year limit: nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.) 8. Any active uncontrolled systemic viral, bacterial, or fungal infection. 9. Any antimicrobial, antiviral, or antifungal therapy within 1 week prior to the first dose of brentuximab vedotin (routine prophylaxis is acceptable). 10. Known cerebral/meningeal disease, including signs or symptoms suggestive of PML, or any history of PML. 11. Known human immunodeficiency virus (HIV). 12. Known hepatitis B surface antigen positive, or known or suspected active hepatitis C infection. 13. Grade 2 or higher peripheral neuropathy. Current therapy with other systemic antineoplastic or investigational agents. 15. Therapy with corticosteroids at higher than or equal to 20 mg/day of prednisone equivalent within 1 week before administration of the first dose of brentuximab vedotin. 16. Patients with a known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation. 17. Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the antitumor efficacy, as determined by the objective response rate (ORR) of single-agent brentuximab vedotin 1.8 mg/kg administered intravenously (IV) every 3 weeks, in patients with relapsed or refractory classical HL who are considered to be not suitable for SCT or multiagent chemotherapy;Secondary Objective: To determine the duration of tumor control, including the duration of response (DOR), progression-free survival (PFS), and complete remission (CR) rate by independent review facility (IRF) assessment after treatment with brentuximab vedotin To determine the proportion of patients who receive hematopoietic SCT, either autologous stem cell transplantation (ASCT) or allogeneic stem cell transplantation (alloSCT) after treatment with brentuximab vedotin To determine overall survival (OS) after treatment with brentuximab vedotin To assess the safety and tolerability of brentuximab vedotin in this patient population To assess the pharmacokinetics (PK) of brentuximab vedotin To determine the immunogenicity of brentuximab vedotin;Primary end point(s): Objective response rate (ORR) per independent review facility (IRF);Timepoint(s) of evaluation of this end point: - Screening - At the End of Treatment Visit: 30 days after last dose of study drug - During the follow up period: Every 3 months for 18 months from EOT or until the sooner of disease progression, death or study closure.Overall survival data will be collected every 3 months from EOT for 18 months, then every 6 months thereafter until the sooner of death or study closure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: -Duration of response, PFS, CR rate, and duration of CR, by IRF assessment Proportion of patients who receive SCT after treatment with brentuximab vedotin -OS -Incidence, severity, and relatedness of AEs; SAEs; and clinical laboratory abnormalities -PK for brentuximab vedotin, MMAE, and total antibody -Determine the Immunogenecity The exploratory endpoints are: -TTP, time to response (either CR or PR), time to best response, and time to CR, by IRF assessment -Serum and/or plasma concentrations of serum biomarkers, sCD30, IL-6, and TARC -B symptom resolution rate -Health care utilization data;Timepoint(s) of evaluation of this end point: The secondary endpoints will be evaluated at the end of trial visit. | — |
Countries
Czech Republic, Germany, Malaysia, Poland, Spain, Thailand, Turkey
Contacts
Public ContactDrug Information Call Centre
Millennium, Drug Information Call Centre
Outcome results
None listed