Trial · NCT01226472
Extension Study in Subjects Who Relapsed After Complete Response on Study KW-0761-001
NCT01226472, Phase 2, Completed, Kyowa Kirin Co., Ltd.; results first posted 2020-12-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extension Study in Subjects Who Relapsed After Complete Response on Study KW-0761-001. Trials, record NCT01226472. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01226472
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study in Subjects Who Relapsed After Complete Response on Study KW-0761-001
- NCT number
- NCT01226472
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Conditions
- Peripheral T-cell Lymphoma, Cutaneous T-cell Lymphoma
- Interventions
- KW-0761
- First posted
- 2010-10-22
- Last updated
- 2024-04-25
- Results first posted
- 2020-12-29
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging | one year | |
| Secondary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | one year |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging | one year | Safety Analysis Set: All subjects who received at least one dose of KW-0761 (even a partial dose). | days | NUMBER |
| SECONDARY | Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | one year | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging | KW-0761 | Progression-Free Survival (PFS) | 260 | days | |
| Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging | KW-0761 | Time to Progression (TTP) | 260 | days | |
| Global Composite Response (Skin, Blood, Lymph Nodes)as Determined by Skin Evaluations, Blood Counts and PET/CT Imaging | KW-0761 | Duration of Overall Response (DR) | 232 | days | |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | KW-0761 | With Any TEAE | 1 | Participants | |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | KW-0761 | With Any Drug-related TEAE | 0 | Participants | |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | KW-0761 | With Any TEAE with an Outcome of Death | 0 | Participants | |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | KW-0761 | With Any Serious TEAE | 0 | Participants | |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | KW-0761 | With Any Drug-related Serious TEAE | 0 | Participants | |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability. | KW-0761 | With Any Serious TEAE with an Outcome of Death | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | KW-0761 | 1 | |
| Overall Study | COMPLETED | KW-0761 | 0 | |
| Overall Study | NOT COMPLETED | KW-0761 | 1 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypophosphataemia | Metabolism and nutrition disorders | KW-0761 | 1 | 1 | 2 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | KW-0761 | 0 | 1 |
| Total, other adverse events | KW-0761 | 1 | 1 |
| Total, serious adverse events | KW-0761 | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01226472
GET https://conductscience.org/api/trials/v1/NCT01226472/registered