A Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Hodgkin Lymphoma

Millennium Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Hodgkin Lymphoma

Treatments: Drug: Brentuximab Vedotin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01990534

C25007

U1111-1154-2250 (Registry Identifier)

2013-000232-10 (EudraCT Number)

NMRR-13-1246-18099 (Registry Identifier)

REec-2014-0619 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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 will enroll 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Brentuximab Vedotin 1.8 mg/kg

Experimental group

Description:

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 could be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.

Treatment:

Drug: Brentuximab Vedotin