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

NCT ID: NCT01950364

Last Updated: 2016-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-06-30

Brief Summary

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.

Conditions

Hodgkin Lymphoma; Anaplastic Large-cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: Brentuximab vedotin

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

Group Type: EXPERIMENTAL

brentuximab vedotin

Intervention Type: DRUG

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

Arm B: Brentuximab vedotin and rifampicin

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.

Group Type: EXPERIMENTAL

Brentuximab vedotin and rifampicin

Intervention Type: DRUG

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.

Interventions

brentuximab vedotin

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

Intervention Type: DRUG

Brentuximab vedotin and rifampicin

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.

Intervention Type: DRUG

Other Intervention Names

SGN-35; SGN-35

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Millennium Pharmaceuticals, Inc.

Locations

Brussels, , Belgium

Ghent, , Belgium

Vilnius, , Lithuania

Barcelona, , Spain

Madrid, , Spain

Salamanca, , Spain

Countries

Belgium; Lithuania; Spain

Other Identifiers

2013-000193-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1174-1958

Identifier Type: REGISTRY

Identifier Source: secondary_id

C25005

Identifier Type: -

Identifier Source: org_study_id