A Phase 2 interventional study of KW-0761 in Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma, sponsored by Kyowa Kirin Co., Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-25.
Sponsored by Kyowa Kirin Co., Ltd. · Phase 2, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 1 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Kyowa Kirin Co., Ltd. is the lead sponsor of 155 studies on the registry; 10 are open to participants now.
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The subject has relapsed after achieving a complete response to treatment with KW 0761 for PTCL or CTCL on study, KW-0761-001.
Exclusion Criteria:
Biological: 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.
Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging
Time frame: one year
Number of Participants With Adverse Events as a Measure of Safety and Tolerability.
Time frame: one year
| Milestone | KW-0761 |
|---|---|
| Started | 1 |
| Completed | 0 |
| Not completed | 1 |
| Withdrew: Progressive disease | 1 |
| days | KW-0761 |
|---|---|
| Progression-Free Survival (PFS) | 260 |
| Time to Progression (TTP) | 260 |
| Duration of Overall Response (DR) | 232 |
| Participants | KW-0761 |
|---|---|
| With Any TEAE | 1 |
| With Any Drug-related TEAE | 0 |
| With Any TEAE with an Outcome of Death | 0 |
| With Any Serious TEAE | 0 |
| With Any Drug-related Serious TEAE | 0 |
| With Any Serious TEAE with an Outcome of Death | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| KW-0761 | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | KW-0761 |
|---|---|
| HypophosphataemiaMetabolism and nutrition disorders | 1/1 |
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.
| Age, Categorical(Participants) | KW-0761 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 1 |
| Sex: Female, Male(Participants) | KW-0761 |
|---|---|
| Female | 0 |
| Male | 1 |
| Race/Ethnicity, Customized(Participants) | KW-0761 |
|---|---|
| White, Hispanic or Latino | 1 |
| Region of Enrollment(participants) | KW-0761 |
|---|---|
| United States | 1 |
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Kyowa Kirin Co., Ltd.