Status:
COMPLETED
Phase I Study of KW-0761 in Relapsed Patients With CCR4-Positive ATL and PTCL
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Adult T-Cell Leukemia and Lymphoma (ATL)
Adult Peripheral T-Cell Lymphoma (PTCL)
Eligibility:
All Genders
20-69 years
Phase:
PHASE1
Brief Summary
This is a Phase I 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).
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...
Eligibility Criteria
Inclusion
- 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
- 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;
- Active tuberculosis;
- Prior stem cell transplantation;
- Myocardial infarction (within 12 months prior to the study entry);
- Concurrent acute or chronic hepatitis, or cirrhosis;
- Anti-HCV: positive, Anti-HIV: positive
- Concurrent active malignant disease;
- Known allergic reaction to antibody therapy;
- Concomitant treatment with systemic steroids;
- Prior and Concurrent psychiatric disorder including dementia, epilepsy or any other CNS diseases;
- Evidence of CNS metastasis at baseline;
- Prior and Concurrent spinal cord disease;
- Radiation therapy for bulky mass disease at the time of study entry or considered to require radiation therapy during the study;
- Female patients who are pregnant or breast feeding;
- Female patients of childbearing potential, unwilling to use an approved, effective means of contraception in accordance with the institution's standards;
- Treatment with any other investigational agent within the 4 months prior to study entry;
- For any reason is judged by the Investigator to be inappropriate for study participation, including an inability to communicate or cooperate with the Investigator.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00355472
Start Date
February 1 2007
End Date
October 1 2008
Last Update
October 18 2012
Active Locations (1)
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1
Tokyo, Japan