Trial · NCT01728805
Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL
NCT01728805, Phase 3, Completed, Kyowa Kirin, Inc.; results first posted 2019-04-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL. Trials, record NCT01728805. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01728805
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL
- NCT number
- NCT01728805
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 372 participants, actual
- Lead sponsor
- Kyowa Kirin, Inc.
- Conditions
- Cutaneous T-Cell Lymphoma
- Interventions
- KW-0761, Vorinostat
- First posted
- 2012-11-20
- Last updated
- 2024-04-25
- Results first posted
- 2019-04-11
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival | From date of randomization at every visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months | Progression was defined as follows, based on Olsen (2011): * Lymph nodes: ≥ 50% increase in SPD from baseline of lymph nodes, any new node \> 1.5 cm in the long axis or \> 1 cm in the short axis if 1-1.5 cm in the long axis that is proven to be N3 histologically, or \> 50% increase from nadir in SPD of lymph nodes in those with PR * Skin: ≥ 25% increase in skin disease from baseline, new tumors (T3) in patients with T1, T2 or T4 only skin disease, or in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score * Blood: B0 to B2, \> 50% increase from baseline and at least 5,000 neoplastic cells/μL36, or \> 50% increase from nadir and at least 5,000 neoplastic cells/μL * Viscera: \> 50% increase in size (SPD) of any organs involved at baseline, new organ involvement, or \> 50% increase from nadir in the size (SPD) of any previous organ involvement in those with PR |
| Secondary | Overall Response Rate | at the end of cycle 1 (26-28 days), and then every other cycle in Year 1 (cycle 3, 5, 7, 9, 11, 13), and every 16 weeks (cycle 17, 21, etc.) in Year 2 and beyond until progression up to 36 months | The ORR was defined as the count of subjects who had a confirmed CR or PR, defined as documented CR or PR per Global Composite Response Score that was confirmed by a subsequent observation at least 4 weeks later. Overall Response Rate was determined based on the response in all compartments (lymph nodes, skin, peripheral blood, and viscera), referencing Olsen, 2011 as follows: Complete Response (CR) = complete disappearance of all clinical evidence of disease; Partial Response (PR) = regression of measurable disease; Stable Disease (SD) = failure to attain CR, PR, or PD; Progressive Disease (PD) = PD in any compartment; Relapse = recurrence of disease in prior CR in any compartment. |
| Secondary | Quality of Life (QoL) Assessment - Skindex-29 Symptoms Scale Score | Cycle 1, 3, and 5 | * Skindex-29 rates 29 items assessing 3 domains (emotions, symptoms, \& functioning) on a linear scale from 0 (never) to all the time (100). Higher scores = higher impact of skin disease. * FACT-G rates 27 items in 4 domains (physical well-being, social/family well-being, emotional well-being, functional well-being) on a 5-point scale from 0 (not at all) to 4 (very much). Higher scores = better QoL. * EuroQoL lvl 3 (Eq-5D-3L) rates mobility, self-care, usual activities, pain/discomfort and anxiety/depression on 3 levels - no problems, some problems, extreme problems. Score is calculated using a set of item weights to derive a single score ranging from -0.109 to 1, with 1 representing full health. LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate. |
| Secondary | Pruritis Evaluation | Cycle 1, 3, and 5 | The Itchy QoL is a validated pruritus specific quality of life instrument. It includes 22 pruritus-specific questions covering three major domains: symptoms, functioning, and emotions. The scale ranges from Never (1) to All The Time (5). The subscale scores consist of the average of the responses to the items in a given subscale. The overall score is the average of the responses to all items. Higher Itchy QoL scores indicate worse quality of life. LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival | From date of randomization at every visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months | percentage of subjects | NUMBER | |
| SECONDARY | Overall Response Rate | at the end of cycle 1 (26-28 days), and then every other cycle in Year 1 (cycle 3, 5, 7, 9, 11, 13), and every 16 weeks (cycle 17, 21, etc.) in Year 2 and beyond until progression up to 36 months | The total number of patients analyzed are further broken out by disease type \[mycosis fungoides (MF) and Sezary Syndrome (SS)\] | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Quality of Life (QoL) Assessment - Skindex-29 Symptoms Scale Score | Cycle 1, 3, and 5 | The number of subjects analyzed in each row is the number of subjects with values at baseline and the specified post-baseline timepoint. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Pruritis Evaluation | Cycle 1, 3, and 5 | The number of participants analyzed were subjects with values at baseline and post-baseline. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival | KW-0761 | Rate (%) of Being Alive w/o Progression at 6 mos. | 55.3 | 95% Confidence Interval 47.1 to 62.6 | percentage of subjects |
| Progression Free Survival | Vorinostat | Rate (%) of Being Alive w/o Progression at 6 mos. | 28.8 | 95% Confidence Interval 21.6 to 36.3 | percentage of subjects |
| Progression Free Survival | KW-0761 | Rate (%) of Being Alive w/o Progression at 12 mos. | 38.3 | 95% Confidence Interval 30.2 to 46.4 | percentage of subjects |
| Progression Free Survival | Vorinostat | Rate (%) of Being Alive w/o Progression at 12 mos. | 15.3 | 95% Confidence Interval 9.5 to 22.3 | percentage of subjects |
| Progression Free Survival | KW-0761 | Rate (%) of Being Alive w/o Progression at 18 mos. | 28.0 | 95% Confidence Interval 19.8 to 36.8 | percentage of subjects |
| Progression Free Survival | Vorinostat | Rate (%) of Being Alive w/o Progression at 18 mos. | 7.2 | 95% Confidence Interval 2.7 to 14.5 | percentage of subjects |
| Progression Free Survival | KW-0761 | Rate (%) of Being Alive w/o Progression at 24 mos. | 14.1 | 95% Confidence Interval 6.4 to 24.8 | percentage of subjects |
| Progression Free Survival | Vorinostat | Rate (%) of Being Alive w/o Progression at 24 mos. | 7.2 | 95% Confidence Interval 2.7 to 14.5 | percentage of subjects |
| Progression Free Survival | KW-0761 | Rate (%) of Being Alive w/o Progression at 30 mos. | 4.7 | 95% Confidence Interval 0.5 to 17.7 | percentage of subjects |
| Progression Free Survival | Vorinostat | Rate (%) of Being Alive w/o Progression at 30 mos. | 7.2 | 95% Confidence Interval 2.7 to 14.5 | percentage of subjects |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization Period | STARTED | KW-0761 | 186 | |
| Randomization Period | STARTED | Vorinostat | 186 | |
| Randomization Period | STARTED | Vorinostat Original Then Crossover to KW-0761 | 0 | |
| Randomization Period | COMPLETED | KW-0761 | 186 | |
| Randomization Period | COMPLETED | Vorinostat | 186 | |
| Randomization Period | COMPLETED | Vorinostat Original Then Crossover to KW-0761 | 0 | |
| Randomization Period | NOT COMPLETED | KW-0761 | 0 | |
| Randomization Period | NOT COMPLETED | Vorinostat | 0 | |
| Randomization Period | NOT COMPLETED | Vorinostat Original Then Crossover to KW-0761 | 0 | |
| Crossover Period | STARTED | KW-0761 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events729
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 | Anaemia | Blood and lymphatic system disorders | KW-0761 | 20 | 184 | 35 |
| other | Anaemia | Blood and lymphatic system disorders | Vorinostat | 18 | 186 | 20 |
| other | Anaemia | Blood and lymphatic system disorders | Vorinostat Original Then Crossover to KW-0761 | 9 | 135 | 10 |
| other | Neutropenia | Blood and lymphatic system disorders | KW-0761 | 0 | 184 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Vorinostat | 0 | 186 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Vorinostat Original Then Crossover to KW-0761 | 7 | 135 | 8 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | KW-0761 | 21 | 184 | 34 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Vorinostat | 56 | 186 | 83 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Vorinostat Original Then Crossover to KW-0761 | 11 | 135 | 48 |
| other | Dry Eye | Eye disorders | KW-0761 | 7 | 184 | 7 |
1 to 10 of 729Source ClinicalTrials.gov
See all 729 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | KW-0761 | 40 | 184 |
| Total, all-cause mortality | Vorinostat | 47 | 186 |
| Total, all-cause mortality | Vorinostat Original Then Crossover to KW-0761 | 32 | 135 |
| Total, other adverse events | KW-0761 | 178 | 184 |
| Total, other adverse events | Vorinostat | 182 | 186 |
| Total, other adverse events | Vorinostat Original Then Crossover to KW-0761 | 128 | 135 |
| Total, serious adverse events | KW-0761 | 69 | 184 |
| Total, serious adverse events | Vorinostat | 46 | 186 |
| Total, serious adverse events | Vorinostat Original Then Crossover to KW-0761 | 40 | 135 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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.
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