For Healthcare Professionals

Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma

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About the study

The purpose of this study is to assess the antitumor efficacy of single-agent brentuximab vedotin 1.8 mg/kg administered intravenously (IV) every 3 weeks, as measured by the overall objective response rate (ORR) in patients with r/r sALCL following at least 1 multiagent chemotherapy regimen (cyclophosphamide, doxorubicin hydrochloride [hydroxydaunorubicin], vincristine sulfate [Oncovin], and prednisone [CHOP] or equivalent multiagent chemotherapy regimens with curative intent).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Male or female participants age 18 years or older, with relapsed or refractory sALCL who have previously received at least 1 multiagent chemotherapy
  2. Bidimensional measurable disease
  3. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  4. 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
  5. 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
  6. Clinical laboratory values as specified in the study protocol

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Previous treatment with brentuximab vedotin.
  2. Previously received an allogeneic transplant.
  3. Participants with current diagnosis of primary cutaneous anaplastic large cell lymphoma [ALCL] (participants whose ALCL has transformed to sALCL are eligible).
  4. Known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (PML)
  5. Female participants who are lactating and breastfeeding or pregnant
  6. Known human immunodeficiency virus (HIV) positive
  7. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Lymphoma

Age (in years)

18+

Phase

Phase 4

Participants needed

50

Est. Completion Date

Oct 4, 2024

Treatment type

Interventional


Sponsor

Takeda

ClinicalTrials.gov identifier

NCT01909934

Study number

C25006

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