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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Kyowa Hakko Kirin Pharma, Inc.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01626664
First received: June 19, 2012
Last updated: March 12, 2014
Last verified: March 2014
  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 ]

Estimated Enrollment: 70
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: July 2014 (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)
  • Positive for hepatitis B or hepatitis C via quantitative PCR;
  • 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;
  • 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

Contacts
Contact: Mei Hentrup 609-580-7414 mhentrup@kyowa-kirin-pharma.com
Contact: Karen Dwyer 609-580-7362 kdwyer@kyowa-kirin-pharma.com

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Almar Guevarra    310-423-1365    almar.guevarra@cshs.org   
Principal Investigator: Maria Delioukina, MD         
United States, Florida
University of Miami / Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Nathalie Luis    305-243-7648    nluis@med.miami.edu   
Principal Investigator: Juan C Ramos, M.D.         
United States, Georgia
The Winship Cancer Institute Withdrawn
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Angela Cisneros    312-695-1384    angela-cisneros@northwestern.edu   
Principal Investigator: Adam Petrich, MD         
United States, Maryland
National Cancer Institute Recruiting
Bethesda, Maryland, United States, 20892
Contact: Tat'Yana Worthy    301-496-0499    worthyt@mail.nih.gov   
Principal Investigator: Kevin Conlon         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Sarah Larson    314-362-3257    salarson@dom.wustl.edu   
Principal Investigator: Lee Ratner         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Marisa Valentinetti    551-996-8073    Mvalentinetti@Hackensackumc.org   
Principal Investigator: Tatyana Feldman         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Lawrence Almanzar    718-920-6642    lalmanza@montfiore.org   
Principal Investigator: Murali Janakiram         
Columbia Presbyterian Recruiting
New York, New York, United States, 10032
Contact: Delcia Rivas    212-305-2696    dr2570@cumc.columbia.edu   
Principal Investigator: Adrienne Phillips, M.D., M.P.H.         
Memorial Sloan Kettering Recruiting
New York, New York, United States, 10021
Contact: Sumithra Nair    646-449-1305    nairs2@mskcc.org   
Principal Investigator: Steven Horwitz, MD         
Belgium
Cliniques Universitaires Saint-Luc Recruiting
Bruxelles, Belgium, 1200
Contact: Annick Bourgois    3227641810    annick.bourgois@uclouvain.be   
Principal Investigator: Violaine Havelange         
Brazil
Hospital Universitario Professor Edgard Santos- UFBA Not yet recruiting
Salvador, Bahia, Brazil, 40110-060
Contact: Estela Luz    55 71 3283-8123    eluz5@yahoo.com.br   
Principal Investigator: Carlos Brites Alves         
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Not yet recruiting
Sao Paulo- SP, Brazil, CEP 05403-000
Contact: Maris Stella Sugino    55 11 3061.5544 ext 243    maris.sugino@hc.fm.usp.br   
Principal Investigator: Juliana Pereira         
France
CHU de Fort de France Recruiting
Fort de France Cedex, France, BP 632 97261
Contact: Rose Mickaëlle    05 96 59 26 23    Mickaelle.Rose@chu-fortdefrance.fr   
Principal Investigator: Jean-Come Meniane         
Hospital Necker Recruiting
Paris, France, 75743
Contact: Thamila Saheb    33 14-449-5663    thamila.berdous-saheb@nck.aphp.fr   
Principal Investigator: Olivier Hermine, M.D.         
Peru
Hospital Nacional Edgardo Rebagliati Martins Recruiting
Lima, Peru, Lima11
Contact: Liliana Osorio    511 4702121    aliliana_investigación@yahoo.es   
Principal Investigator: Brady Beltran         
Hospital Peruano Cayetano Heredia Not yet recruiting
Lima, Peru, Lima31
Contact: Milagro Melendez    51 96-375-7147    milagroaraujo@yahoo.com   
Principal Investigator: Miro Rodriguez Inocente         
Instituto Oncologico Miraflores Recruiting
Lima, Peru, Lima18
Contact: Mireya Tejada    511 6512958    mireyatejada2003@yahoo.es   
Principal Investigator: Luis Casanova         
United Kingdom
Guy's Hospital Recruiting
London, United Kingdom, SE1 9RT
Contact: Claire Woodley    +44 207 188 1425 ext 2294    claire.woodley@gstt.nhs.uk   
Principal Investigator: Paul Fields, M.D.         
Imperial College Recruiting
London, United Kingdom, W2 1PG
Contact: Lucy Cook    44 203 312 1521    l.cook@imperial.ac.uk   
Principal Investigator: Graham Taylor, M.D.         
Sandwell General Hospital Recruiting
West Midlands, United Kingdom, B71 4HJ
Contact: Lisa Smith    0121 507 2470    lisa.smith26@nhs.net   
Principal Investigator: Farooq Wandroo         
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: March 12, 2014
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
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Cytarabine
Gemcitabine
Oxaliplatin
Cisplatin
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents

ClinicalTrials.gov processed this record on July 22, 2014