Peripheral T-cell Lymphoma, Cutaneous T-cell Lymphoma
Conditions
Keywords
PTCL, CTCL, MF, SS
Brief 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.
Interventions
BIOLOGICALKW-0761
In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.
Sponsors
Kyowa Hakko Kirin Pharma, Inc.
Kyowa Kirin Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. 2\. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of \< 2 at study entry. 3\. The subject is \>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. 5\. 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. 6\. The subject has serum creatinine ≤1.5 x ULN or a calculated creatinine clearance \>60 mL/min. 7\. Subjects with MF and a history of staphylococcus colonization are eligible provided they continue to receive stable doses of prophylactic antibiotics.
Exclusion criteria
1. The subject has received any type of treatment for their disease since completing study, KW-0761-001. 2. 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. 3. Subjects on any immunomodulatory drug, (other than low dose corticosteroids equivalent to a daily dose of 10 mg of prednisone 4. 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. 5. The subject has experienced allergic reactions to monoclonal antibodies or other therapeutic proteins. 6. Subjects with active herpes simplex or herpes zoster. 7. Subjects with known autoimmune diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging | one year |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | one year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| KW-0761 KW-0761: In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week. | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Progressive Disease | 1 |
Baseline characteristics
| Characteristic | KW-0761 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race/Ethnicity, Customized White, Hispanic or Latino | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging
Time frame: one year
Population: Safety Analysis Set: All subjects who received at least one dose of KW-0761 (even a partial dose).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| KW-0761 | Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging | Progression-Free Survival (PFS) | 260 days |
| KW-0761 | Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging | Time to Progression (TTP) | 260 days |
| KW-0761 | Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging | Duration of Overall Response (DR) | 232 days |
Secondary
Number of Participants With Adverse Events as a Measure of Safety and Tolerability.
Time frame: one year
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| KW-0761 | Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | With Any TEAE | 1 Participants |
| KW-0761 | Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | With Any Drug-related TEAE | 0 Participants |
| KW-0761 | Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | With Any TEAE with an Outcome of Death | 0 Participants |
| KW-0761 | Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | With Any Serious TEAE | 0 Participants |
| KW-0761 | Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | With Any Drug-related Serious TEAE | 0 Participants |
| KW-0761 | Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | With Any Serious TEAE with an Outcome of Death | 0 Participants |