KW 0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01626664
First received: June 19, 2012
Last updated: May 11, 2015
Last verified: May 2015
  Purpose

The purpose of this study is to estimate the overall response rate of subjects with relapsed or refractory Adult T-cell Leukemia-Lymphoma (ATL).


Condition Intervention Phase
Adult T-cell Leukemia-Lymphoma
Biological: KW-0761
Drug: investigator's choice (pralatrexate; gemcitabine/oxaliplatin; dexamethasone/cisplatin/cytarabine)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Pharma, Inc.:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression free survival [ Time Frame: From date of randomization until the date of first documented progression, start of alternative therapy, or date of death from any cause, whichever came first, up to 36 months ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
  • Quality of Life assessments [ Time Frame: up tp 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: June 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KW-0761
anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)
Biological: KW-0761
1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
Other Names:
  • mogamulizumab
  • POTELIGEO®
Active Comparator: investigator's choice
Comparator is investigator's choice of pralatrexate or gemcitabine plus oxaliplatin or DHAP
Drug: investigator's choice (pralatrexate; gemcitabine/oxaliplatin; dexamethasone/cisplatin/cytarabine)
  • pralatrexate (30 mg/m2 weekly for 3 weeks until progression)
  • gemcitabine plus oxaliplatin (gemcitabine 1000 mg/m2, oxaliplatin 100 mg/m2 every 2 weeks until progression)
  • DHAP (dexamethasone 40 mg on day 1-4, cisplatin 100 mg/m2, cytarabine 2000 mg/m2 every 4 weeks until progression)
Other Names:
  • Folotyn
  • Gemzar
  • Eloxitin

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 entry
  • 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:

  • Smoldering subtype of ATL;
  • Lymphomatous or acute subtype subject with > 2 prior systemic therapy regimens and who has not achieved a response (CR or PR) or maintained stable disease for at least 12 weeks on last immediate prior therapy;
  • History of allogeneic transplant;
  • Autologous hematopoietic stem cell transplant within 90 days of study entry;
  • Untreated human immunodeficiency virus (HIV)
  • Has known hepatitis C. Patients who are hepatitis C antibody positive but are hepatitis C quantitative PCR negative may be enrolled;
  • Has hepatitis B based on PCR testing for hepatitis B virus DNA. Patients who are hepatitis B core antibody positive but PCR negative may be enrolled if placed on appropriate anti-hepatitis B virus prophylaxis prior to commencing treatment with KW-0761. Patients who are hepatitis B core antibody positive based on prior vaccination need not receive prophylaxis;
  • 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 requirements;
  • Significant uncontrolled intercurrent illness
  • Experienced allergic reactions to monoclonal antibodies or other therapeutic proteins;
  • 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. Subjects on a stable dose of medium or low potency topical corticosteroids for at least 4 weeks prior to Pre-treatment Visit may continue use at the same dose, although the investigator should attempt to taper the use to lowest dose tolerable;
  • Have had interferon-α and/or zidovudine within 1 week, or anti-neoplastic chemotherapy, radiation, immunotherapy, or investigational medications within 2 weeks of first study treatment;
  • Subjects on any immunomodulatory drug. Subjects on any immunomodulatory drug within 4 weeks of their first dose of KW-0761 are also excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626664

Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
University of Miami / Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
National Cancer Institute
Bethesda, Maryland, United States, 20892
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Columbia Presbyterian
New York, New York, United States, 10032
Memorial Sloan Kettering
New York, New York, United States, 10021
Weill Cornell Medical College
New York, New York, United States, 10065
Belgium
Cliniques Universitaires Saint-Luc
Bruxelles, Belgium, 1200
Brazil
Hospital Universitario Professor Edgard Santos- UFBA
Salvador, Bahia, Brazil, 40110-060
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Sao Paulo- SP, Brazil, CEP 05403-000
France
CHU de Fort de France
Fort de France Cedex, France, BP 632 97261
Hospital Necker
Paris, France, 75743
Peru
Instituto Oncologico Miraflores
Lima, Peru, Lima18
Hospital Nacional Edgardo Rebagliati Martins
Lima, Peru, Lima11
United Kingdom
Guy's Hospital
London, United Kingdom, SE1 9RT
Imperial College
London, United Kingdom, W2 1PG
Sandwell General Hospital
West Midlands, United Kingdom, B71 4HJ
Sponsors and Collaborators
Kyowa Hakko Kirin Pharma, Inc.
Investigators
Study Director: Michael Kurman, MD Kyowa Hakko Kirin Pharma, Inc.
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01626664     History of Changes
Other Study ID Numbers: PROTOCOL 0761-009
Study First Received: June 19, 2012
Last Updated: May 11, 2015
Health Authority: United States: Food and Drug Administration
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Belgium: Federal Agency for Medicines and Health Products, FAMHP
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Brazil: National Committee of Ethics in Research
Peru: Instituto Nacional de Salud

Keywords provided by Kyowa Hakko Kirin Pharma, Inc.:
Adult T cell Leukemia-Lymphoma (ATL)

Additional relevant MeSH terms:
Leukemia
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Leukemia, Lymphoid
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cytarabine
Dexamethasone
Gemcitabine
Oxaliplatin
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antiviral Agents
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 27, 2015