A randomized, double-blind, placebo-controlled, phase 3 study of brentuximab vedotin and CHP (A+CHP) versus CHOP in the frontline treatment of patients with CD30-positive mature T-cell lymphomas: the ARROVEN study

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women with mature T-cell lymphoma (MTCL) that has never been treated.

The study uses a drug called brentuximab vedotin (also called ADCETRIS) in combination with other drugs approved for use in cancer patients. Brentuximab vedotin is FDA-approved to treat certain types of lymphoma but not for untreated MTCL.

The standard of care for newly diagnosed MTCL is treatment with a combination of drugs called CHOP (cyclophosphamide, hydroxydoxorubicin, vincristine(also called Oncovin), and prednisone). This study is being done to compare CHOP to a combination that replaces vincristine with brentuximab vedotin. This combination is called A+CHP (brentuximab vedotin (ADCETRIS) plus cyclophosphamide, hydroxydoxorubicin, and prednisone).

Brentuximab vedotin is a type of drug called an antibody drug conjugate, or ADC. ADCs usually have two parts—a part that targets cancer cells (the antibody) and the part that kills cancer cells (the chemotherapy). The antibody part of brentuximab vedotin sticks to a target called CD30, an important molecule on some cancer cells. This study will enroll people who have CD30 on their tumor cells.

Study participants will be randomly assigned to receive:

  • 6 to 8 cycles of treatment with CHOP, or
  • 6 to 8 cycles of brentuximab vedotin plus CHP (A + CHP)

Treatment cycles are 21 days. After completing treatment (approximately 6 months to complete 8 cycles), participants will be followed up for up to 7 years. 

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Disease Status and/or Stage

Untreated Mature T-Cell Lymphoma

Sponsor

Seattle Genetics

Key Eligibility

  • Men and women age 18 and older
  • Newly diagnosed, CD30-positive mature T-cell lymphomas
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Jia Ruan, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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