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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 2
18 Years
Open (Enrolling)
Adult T-cell Leukemia-Lymphoma

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Trial Information

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)

CCR4 expression in ATL patients has been demonstrated to be very high and has been
associated with shorter survival compared with CCR4-negative patients. KW-0761, a monoclonal
antibody targeted to CCR4, has been shown to be safe and tolerable in several clinical
trials in subjects with a variety of T-cell malignancies, including ATL, mycosis fungoides
and Sézary syndrome. The objective of this study is to estimate the overall response rate of
KW-0761 for subjects with relapsed or refractory ATL.

Inclusion Criteria:

- Males and female subjects ≥ 18 years of age

- Confirmed diagnosis of ATL (excluding smoldering subtype)

- Subjects must currently have evidence of disease in at least one of the following:

- Lymph nodes

- Extranodal masses

- Spleen or liver

- Skin

- Peripheral blood

- Bone marrow

- Relapsed or refractory after at least one prior systemic therapy regimen for ATL;

- Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2 at study

- resolution of all clinically significant toxic effects of prior cancer therapy to
grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse
Events, version 4.0 (NCI-CTCAE, v.4.0)

- adequate hematological, hepatic and renal function

Exclusion Criteria:

- History of allogeneic transplant;

- Autologous hematopoietic stem cell transplant within 90 days of study entry;

- Untreated human immunodeficiency virus (HIV)

- Has known or tests positive for hepatitis B or C;

- Have had a malignancy in the past two years except non-melanoma skin cancers,
melanoma in situ, localized cancer of the prostate with current PSA < 0.1 µg/mL,
treated thyroid cancer or cervical carcinoma in situ or ductal/lobular carcinoma in
situ of the breast who is currently without evidence of disease;

- Clinical evidence of central nervous system (CNS) involvement or metastasis. In
subjects suspected of having CNS disease, an MRI of the brain and/or lumbar puncture
should be done to confirm;

- Psychiatric illness, disability or social situation that would compromise the
subject's safety or ability to provide consent, or limit compliance with study

- Significant uncontrolled intercurrent illness

- Experienced allergic reactions to monoclonal antibodies or other therapeutic

- Known active autoimmune diseases will be excluded (For example; Grave's disease;
systemic lupus erythematosus; rheumatoid arthritis; Crohn's disease);

- Is pregnant (confirmed by beta human chorionic gonadotrophin [β-HCG]) or lactating.

- Prior treatment with KW-0761;

- Initiation of treatment with systemic corticosteroids while on study is only
permitted for acute and brief complications of underlying disease (e.g.,
hypercalcemia) or for treatment related side effects (e.g., including pre-medication
for infusion reaction, nausea and vomiting). Subjects on systemic corticosteroids
prior to enrollment must be off for 7 days before initiation of study treatment,
unless specifically indicated for the treatment of hypercalcemia. (subjects may
receive inhalation corticosteroids and replacement doses of systemic corticosteroids
as needed);

- Initiation of treatment with topical corticosteroids while on study is not permitted
except to treat an acute rash;

- Have had interferon-α, zidovudine, anti-neoplastic chemotherapy, radiation,
immunotherapy, or investigational medications within 2 weeks of first study

- Subjects on any immunomodulatory drug. Subjects on any immunomodulatory drug within 4
weeks of their first dose of KW-0761 are also excluded.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate

Outcome Time Frame:

every 8 weeks

Safety Issue:


Principal Investigator

Michael Kurman, MD

Investigator Role:

Study Director

Investigator Affiliation:

Kyowa Hakko Kirin Pharma, Inc.


United States: Food and Drug Administration

Study ID:

PROTOCOL 0761-009



Start Date:

June 2012

Completion Date:

June 2015

Related Keywords:

  • Adult T-cell Leukemia-lymphoma
  • Adult T cell Leukemia-Lymphoma (ATL)
  • Leukemia
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma



Washington University School of Medicine Saint Louis, Missouri  63110
Cedars-Sinai Medical Center Los Angeles, California  90048
Montefiore Medical Center Bronx, New York  10467-2490
Northwestern University Chicago, Illinois  60611
Memorial Sloan Kettering New York, New York  10021
National Cancer Institute Bethesda, Maryland  20892-1922
The Winship Cancer Institute Atlanta, Georgia  30322
Columbia Presbyterian - Harlem New York, New York  10032
University of Miami / Sylvester Comprehensive Cancer Center Miami, Florida  33136