A Phase 1 Study in Patients With Relapsed or Refractory Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma

Millennium Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hodgkin Lymphoma; Anaplastic Large-cell Lymphoma

Treatments: Drug: brentuximab vedotin; Drug: Brentuximab vedotin and rifampicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01950364

2013-000193-29 (EudraCT Number)

U1111-1174-1958 (Registry Identifier)

C25005

Details and patient eligibility

About

This is an open-label trial to estimate the concentrations of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma (HL) or relapsed/refractory systemic anaplastic large cell lymphoma (sALCL) participants treated with either brentuximab vedotin or brentuximab vedotin + rifampicin.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female participants between 18 years and 75 years old, with relapsed or refractory HL or relapsed or refractory sALCL who have previously received at least 1 multiagent chemotherapy
• Measurable disease
• An Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1
• 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, from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to practice true abstinence
• 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
• Clinical laboratory values as specified in the study protocol

Exclusion criteria

• Participants for whom rifampicin is contraindicated
• Previously received an allogeneic transplant.
• Participants with current diagnosis of primary cutaneous anaplastic large cell lymphoma (ALCL) (participants whose ALCL has transformed to sALCL are eligible).
• Known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (PML)
• Female participants who are lactating and breastfeeding or pregnant
• Known human immunodeficiency virus (HIV) positive,
• Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Arm A: Brentuximab vedotin

Experimental group

Description:

Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg.

Treatment:

Drug: brentuximab vedotin

Arm B: Brentuximab vedotin and rifampicin

Experimental group

Description:

Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg beginning on Cycle 1, Day 1; daily rifampicin (600 mg PO) will be administered during Cycles 0 through 3 only, beginning on Cycle 0, Day 1 (7 days before the Cycle 1, Day 1 dose of brentuximab vedotin) and continuing through Cycle 3, Day 21.

Treatment:

Drug: Brentuximab vedotin and rifampicin