Overview

This trial is active, not recruiting.

Condition hodgkin lymphoma
Treatment brentuximab vedotin
Phase phase 4
Sponsor Millennium Pharmaceuticals, Inc.
Start date March 2014
End date December 2015
Trial size 60 participants
Trial identifier NCT01990534, 2013-000232-10, C25007, NMRR-13-1246-18099, REec-2014-0619, U1111-1154-2250

Summary

This phase 4, single-arm, open-label, multicenter study is designed to evaluate the efficacy and safety of brentuximab vedotin as a single agent in adult patients with histologically confirmed CD30+ relapsed or refractory classical HL who have not received a prior stem cell transplantation (SCT) and are considered to be not suitable for SCT or multiagent chemotherapy at the time of study entry.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg.
brentuximab vedotin SGN-35
Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg.

Primary Outcomes

Measure
Objective response rate (ORR, complete remission (CR) + partial remission (PR)) as assessed by an independent review facility (IRF) according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma
time frame: Until disease progression, death or study closure (up to 5 years after the enrollment of the last patient)

Secondary Outcomes

Measure
Duration of response, PFS, CR rate, and duration of CR, by IRF assessment
time frame: Until disease progression, death or study closure (up to 5 years after the enrollment of the last patient)
Proportion of patients who receive SCT after treatment with brentuximab vedotin
time frame: Until disease progression, death or study closure (up to 5 years after the enrollment of the last patient)
Overall survival
time frame: Every 3 months for 18 months after end of treatment (EOT), thereafter, every 6 months until the sooner of death, study closure, or 5 years after enrollment of the last patient

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria Each patient must meet all of the following inclusion criteria to be enrolled in the study: 1. Male or female patients 18 years or older, with relapsed or refractory classical HL, who have previously received at least 1 prior systemic chemotherapeutic regimen 2. Not suitable for SCT or multiagent chemotherapy, according to 1 of the following criteria: - Disease progression within 90 days of the earliest date of complete remission (CR) or complete remission unconfirmed (CRu) after the end of treatment with multiagent chemotherapeutic regimens and/or radiotherapy - Progressive disease during frontline multiagent chemotherapy - Disease relapse after treatment with at least 2 chemotherapeutic regimens, including any salvage treatments 3. Bidimensional measurable disease 4. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 5. Female patients who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception at the same time, or agree to practice true abstinence. 6. Male patients who agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug or agree to practice true abstinence. 7. Clinical laboratory values as specified in the study protocol. Exclusion Criteria Patients who meet any of the following exclusion criteria are not to be enrolled in the study: 1. Previous treatment with brentuximab vedotin 2. Previously received an ASCT or alloSCT 3. Known cerebral/meningeal disease, including signs or symptoms suggestive of progressive multifocal leukoencephalopathy (PML), or any history of PML. 4. Female patients who are lactating and breastfeeding or pregnant. 5. Known human immunodeficiency virus (HIV). 6. Known hepatitis B surface antigen positive, or known or suspected active hepatitis C infection. 7. Grade 2 or higher peripheral neuropathy.

Additional Information

Official title A Single-arm Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma Who Are Not Suitable for Stem Cell Transplantation or Multiagent Chemotherapy
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Takeda.