Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Phase I Study of KW-0761 in Relapsed Patients With CCR4-Positive ATL and PTCL
This study is ongoing, but not recruiting participants.
Sponsored by: Kyowa Hakko Kogyo Co., Ltd.
Information provided by: Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier: NCT00355472
  Purpose

This is a Phase I label dose dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell lymphoma (PTCL).


Condition Intervention Phase
Adult T-Cell Leukemia and Lymphoma (ATL)
Adult Peripheral T-Cell Lymphoma (PTCL)
Drug: KW-0761
Phase I

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: Phase I Dose Escalation Study of KW-0761 in Patients With Relapsed Adult T-Cell Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL)

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

Primary Outcome Measures:
  • Safety and tolerability as assessed by adverse events [ Time Frame: At every study visit ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: At selected study visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response (time to progression) [ Time Frame: At every visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
KW-0761
Drug: KW-0761
IV administration at 4 escalating dose levels.

Detailed Description:

This is a Phase I open-label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL). This study is designed to evaluate safety, pharmacokinetics, immunogenicity and preliminary efficacy. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose (RPIID) have been established.

  Eligibility

Ages Eligible for Study:   20 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Histologically confirmed diagnosis of a CCR4-positive ATL and PTCL that is any of the following:

A. ATL (Adult T-Cell Leukemia-Lymphoma)

  • Seropositive for anti-Human T-lymphotrophic Virus type-I (HTLV-I) antibody;
  • Acute, Lymphoma, or Chronic phase with high-risk factors (within 14 days before the study entry);

B. PTCL (Peripheral T-Cell Lymphoma)

  • Includes Mycosis Fungoides and Sezary Syndrome;

    2: Relapsed to the latest standard chemotherapy;

    3: Received at least one prior chemotherapy;

    4: After 4 weeks from a prior therapy;

    5: Have measurable disease;

    6:Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;

    7: Male or female, at least 20 years and not older than 70 years of age;

    8: Signed written informed consent;

    9: Stay in hospital for 4 weeks;

    10: HBs antigen: negative, HBV-DNA: below the limit of quantification (within 14 days before the study entry);

    11: Adequate bone marrow, hepatic and cardiac function including the followings:

  • Neutrophil count ≥ 1,500 /mm3,
  • Platelets ≥ 75,000 /mm3,
  • Hemoglobin ≥ 8.0 g/dL
  • Serum creatinine ≤ 1.5 x ULN;
  • Serum SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN (≤ 5.0 x ULN if considered due to disease involvement in liver);
  • Serum bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN if considered due to disease involvement in liver)
  • Serum calcium ≤ 11.0 mg/dL
  • PaO2 ≥ 65 mmHg or SaO2 ≥ 90%
  • No clinically significant Electrocardiogram abnormality
  • Left Ventricular Ejection Fraction ≥ 50% [by ECHO or MUGA]

Exclusion Criteria:

  1. Co-existing active infection or any co-existing medical condition that may compromise the safety of patients during the study, affect the patient's ability to complete the study, or interfere with interpretation of study results;
  2. Active tuberculosis;
  3. Prior stem cell transplantation;
  4. Myocardial infarction (within 12 months prior to the study entry);
  5. Concurrent acute or chronic hepatitis, or cirrhosis;
  6. Anti-HCV: positive, Anti-HIV: positive
  7. Concurrent active malignant disease;
  8. Known allergic reaction to antibody therapy;
  9. Concomitant treatment with systemic steroids;
  10. Prior and Concurrent psychiatric disorder including dementia, epilepsy or any other CNS diseases;
  11. Evidence of CNS metastasis at baseline;
  12. Prior and Concurrent spinal cord disease;
  13. Radiation therapy for bulky mass disease at the time of study entry or considered to require radiation therapy during the study;
  14. Female patients who are pregnant or breast feeding;
  15. Female patients of childbearing potential, unwilling to use an approved, effective means of contraception in accordance with the institution's standards;
  16. Treatment with any other investigational agent within the 4 months prior to study entry;
  17. For any reason is judged by the Investigator to be inappropriate for study participation, including an inability to communicate or cooperate with the Investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00355472

Locations
Japan
Contact Kyowa Hakko Kogyo, Ltd
Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kogyo Co., Ltd.
Investigators
Study Director: Study Director Kyowa Hakko Kogyo
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Kyowa Hakko Kogyo, Ltd. ( Study Director )
Study ID Numbers: 0761-0501
Study First Received: July 20, 2006
Last Updated: December 4, 2008
ClinicalTrials.gov Identifier: NCT00355472  
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Kyowa Hakko Kirin Pharma, Inc.:
Adult T-Cell Leukemia
ATL
Adult Peripheral T-Cell Lymphoma
PTCL

Study placed in the following topic categories:
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Leukemia-Lymphoma, Adult T-Cell
Lymphoma, T-Cell
Leukemia, T-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma, T-Cell, Peripheral
Lymphoma
Peripheral T-cell lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009