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Phase I Dose Escalation Study of KW-0761 in Patients With Relapsed Adult T-Cell Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL)

Phase 1
20 Years
69 Years
Not Enrolling
Adult T-Cell Leukemia and Lymphoma (ATL), Adult Peripheral T-Cell Lymphoma (PTCL)

Thank you

Trial Information

Phase I Dose Escalation Study of KW-0761 in Patients With Relapsed Adult T-Cell Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL)

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.

Inclusion Criteria:

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

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

- 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

17. For any reason is judged by the Investigator to be inappropriate for study
participation, including an inability to communicate or cooperate with the

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Dose-Limiting Toxicities (DLTs)

Outcome Description:

Subjects who were properly monitored for DLTs were to be analyzed to determine the number of subjects with a DLT by dose level.

Outcome Time Frame:

28 days

Safety Issue:


Principal Investigator

Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Kyowa Hakko Kirin Company, Limited


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

February 2007

Completion Date:

October 2008

Related Keywords:

  • Adult T-Cell Leukemia and Lymphoma (ATL)
  • Adult Peripheral T-Cell Lymphoma (PTCL)
  • Adult T-Cell Leukemia
  • ATL
  • Adult Peripheral T-Cell Lymphoma
  • PTCL
  • Leukemia
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral