Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kyowa Hakko Kirin Pharma, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KW-0761 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KW-0761 | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | one year |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Kurman, M.D. | Kyowa Hakko Kirin Pharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only subjects with PTCL or CTCL who subsequently relapsed after achieving a CR in Study KW 0761-001 and who provided signed informed consent were eligible to enroll in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging | Safety Analysis Set: All subjects who received at least one dose of KW-0761 (even a partial dose). | Posted | Number | days | one year |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kyowa Kirin Pharmaceutical Development | Kyowa Kirin Pharmaceutical Development | 609-919-1100 | kkd.clintrial.82@kyowakirin.com |
Not provided
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C549035 | mogamulizumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | Posted | Count of Participants | Participants | one year |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
Not provided
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
|
| With Any Serious TEAE |
|
| With Any Drug-related Serious TEAE |
|
| With Any Serious TEAE with an Outcome of Death |
|