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

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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
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.

Type of Study:

Interventional

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:

Yes

Principal Investigator

Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Kyowa Hakko Kirin Company, Limited

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

0761-0501

NCT ID:

NCT00355472

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

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