Phase 2
N=1
Extension Study in Subjects Who Relapsed After Complete Response on Study KW-0761-001
Peripheral T-cell Lymphoma · Cutaneous T-cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01226472 ↗Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging — 260; 260; 232 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- KW-0761 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kyowa Kirin Co., Ltd.
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging |
260; 260; 232 | — |
| SECONDARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability. |
1; 0; 0; 0; 0; 0 | — |
Summary
This study will enroll subjects with either Peripheral T-Cell Lymphoma (PTCL) or Cutaneous T-Cell Lymphoma(CTCL),including mycosis fungoides (MF) and Sezary Syndrome (SS), who have relapsed after achieving a complete response in study, KW-0761-001.
Eligibility Criteria
Inclusion Criteria
- 1. The subject has relapsed after achieving a complete response to treatment with KW 0761 for PTCL or CTCL on study, KW-0761-001.
- The subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 18 years of age. 4. The subject has adequate hematological function: absolute neutrophil count [ANC] >1,500 cells/uL and platelets >100,000 cells/uL,except in patients with known bone marrow involvement where absolute neutrophil count [ANC] must be > 1,000 cells/uL and platelets >75,000 cells/uL.
- The subject has adequate hepatic function: bilirubin ≤ 1.5 times the specific institutional upper limit of normal [ULN]; aspartate transaminase [AST] and alanine transaminase [ALT] each ≤ 2.5 x ULN or ≤ 5.0 x ULN in the presence of known hepatic malignancy.
- The subject has serum creatinine ≤1.5 x ULN or a calculated creatinine clearance >60 mL/min.
- Subjects with MF and a history of staphylococcus colonization are eligible provided they continue to receive stable doses of prophylactic antibiotics.
Exclusion Criteria
- The subject has received any type of treatment for their disease since completing study, KW-0761-001.
- The subject has a significant uncontrolled intercurrent illness including, but not limited to: uncontrolled infection requiring antibiotics; clinically significant cardiac disease (class III or IV of the New York Heart Association [NYHA] classification); unstable angina pectoris; angioplasty, stenting, or myocardial infarction within 6 months; uncontrolled hypertension (systolic blood pressure >160 mmHg, diastolic BP >100 mmHg, found on two consecutive measurements separated by a 1 week period) despite two anti-hypertensive medications; clinically significant cardiac arrhythmia; or uncontrolled diabetes.
- Subjects on any immunomodulatory drug, (other than low dose corticosteroids equivalent to a daily dose of 10 mg of prednisone
- The subject has a psychiatric illness, disability or social situation that would compromise the subject's safety or ability to provide consent, or limit his or her compliance with study requirements.
- The subject has experienced allergic reactions to monoclonal antibodies or other therapeutic proteins.
- Subjects with active herpes simplex or herpes zoster.
- Subjects with known autoimmune diseases
Data sourced from ClinicalTrials.gov (NCT01226472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.