A Phase II Study of KW-0761 or Standard Therapy in Patients with Previously Treated Adult T-Cell Leukemia-Lymphoma

Protocol
12-251
Full Title
Multi-Center, Open-Label, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 or Investigator's Choice in Subjects with Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)
Phase
II
Purpose

The identification of effective treatments for adult T-cell leukemia-lymphoma (ATL) is limited. Conventional treatment with chemotherapy regimens is typically the standard approach, but results in relapsed or worsening disease for many patients. The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called KW-0761(mogamulizumab) in patients with ATL that has returned or persists despite prior therapy, and to see how treatment with KW-0761 compares with conventional therapy. KW-0761 is an antibody designed to reduce cancer growth by targeting a protein on ATL cells called CCR4.

Patients will be randomly assigned to receive KW-0761 or a conventional treatment chosen by the investigators (either pralatrexate; gemcitabine and oxaliplatin; or dexamethasone, cisplatin, and cytarabine). Patients whose ATL continues to grow while on conventional therapy may have the option of receiving KW-0761 instead. KW-0761 is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have HTLV-1-positive ATL that has returned or persisted despite at least one prior regimen of therapy
  • At least 2 weeks must have passed since prior chemotherapy, immunotherapy, or radiation therapy before entering the study.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Steven M. Horwitz at 212-639-3045.

Disease(s)
Leukemia
Lymphoma
Lymphoma: Non-Hodgkin's Lymphoma
Locations
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