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 March 2016
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 participants with histologically confirmed CD30+ relapsed or refractory classical Hodgkin Lymphoma 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

Intervention model single group assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
Brentuximab vedotin 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 in every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
brentuximab vedotin SGN-35
Brentuximab vedotin IV infusion

Primary Outcomes

Measure
Objective Response Rate (ORR)
time frame: Baseline up to Cycle 16 (3-week cycle) until disease progression, death or end of treatment (EOT) (Up to 12.2 months)

Secondary Outcomes

Measure
Duration of Response (DOR)
time frame: From first documented response until disease progression (Up to 12.2 months)
Progression Free Survival (PFS)
time frame: Baseline up to Cycle 16 (3-week cycle) until disease progression, death or EOT, and then every 3 months up to data cut-off: 23 May 2016 (approximate median follow-up 6.9 months)
Complete Remission Rate
time frame: Baseline up to Cycle 16 (3-week cycles) until disease progression, death or EOT (Up to 12.2 months)
Duration of Complete Remission (CR)
time frame: From first documented response until disease progression (Up to 12.2 months)
Overall Survival (OS)
time frame: Every 3 months for 18 months after EOT, thereafter, every 6 months until the sooner of death, study closure, or 5 years after enrollment of the last participant up to data cut-off: 23 May 2016 (approximate median follow-up 16.6 months)
Percentage of Participants who Received Stem Cell Transplantation (SCT)
time frame: Baseline up to EOT (Up to 12.2 months)
Number of Participants with Adverse Events (AEs), Drug-Related AEs, Grade 3 or Higher AEs, Serious Adverse Events (SAEs), Drug-Related SAEs and Grade 3 or Higher SAEs
time frame: From the first dose through 30 days after the last dose of study medication (Up to 12.2 months)
Number of Participants with Abnormal Clinical Laboratory Values Reported as AEs
time frame: From the first dose through 30 days after the last dose of study medication (Up to 12.2 months)
Antibody-drug Conjugate (ADC) Serum Concentrations
time frame: Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 12.2 months)
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
time frame: Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 12.2 months)
Monomethyl Auristatin E (MMAE) Serum Concentrations
time frame: Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 12.2 months)
Number of Participants With Antitherapeutic Antibodies (ATA)
time frame: Day 1 of every 3-week cycle up to 16 cycles and EOT (Up to 12.2 months)

Eligibility Criteria

All participants at least 18 years old.

Inclusion Criteria: Each participant must meet all of the following inclusion criteria to be enrolled in the study: 1. Male or female participants 18 years or older, with relapsed or refractory classical Hodgkin lymphoma (HL), who have previously received at least 1 prior systemic chemotherapeutic regimen 2. Not suitable for stem cell transplantation (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 participants 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 participants 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: Participants 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 autologous stem cell transplantation (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 participants 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
Description The drug being tested in this study is called brentuximab vedotin. Brentuximab vedotin is being tested to treat people who have relapsed or refractory Hodgkin Lymphoma. This study will look at the overall response of people who took brentuximab vedotin. The study enrolled 60 patients. Participants received: • Brentuximab vedotin 1.8 mg/kg This multicenter trial is being conducted worldwide. The overall time to participate in this study is approximately 6 to 7 years. Participants will make multiple visits to the clinic, and will be contacted by telephone every 3 months for 18 months after the end of treatment (EOT) for follow-up assessment of overall survival and then every 6 months until death, study closure, or 5 years after enrollment of the last participant.
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Takeda.