Trial · NCT03123588
Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)
NCT03123588, Phase 2, Terminated, Incyte Corporation; results first posted 2021-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272). Trials, record NCT03123588. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03123588
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)
- NCT number
- NCT03123588
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- MPN (Myeloproliferative Neoplasms)
- Interventions
- Ruxolitinib, Anagrelide, Placebo, Placebo
- First posted
- 2017-04-21
- Last updated
- 2021-11-19
- Results first posted
- 2021-11-19
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects Who Achieve Platelet and White Blood Cell (WBC) Control | 52 weeks | Defined as proportion of subjects who achieve a simultaneous reduction of platelet counts to \< 600 × 10\^9/L with a reduction of WBC counts to \< 10 × 10\^9/L for at least 80% of biweekly measurements for a consecutive 12-week period between Weeks 32 and 52. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Baseline through the end of randomized period -up to 14 months per participant | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment. |
| Secondary | Proportion of Subjects Who Achieve Complete Remission or Partial Remission | 32 weeks | Defined as proportion of subjects who achieve CR or PR at Week 32 based on European LeukemiaNet (ELN) 2013 response criteria. Per ELN criteria: Complete Remission: durable resolution of disease related signs and symptoms, durable blood count normalization, absence of hemorrhagic or thrombotic events, absence of signs of progressive disease and bone marrow histological remission including disappearance of megakaryocyte hyperplasia and absence of reticulin fibrosis \>Grade 1. Partial remission: durable resolution of disease related signs and symptoms, durable blood count normalization, absence of hemorrhagic or thrombotic events, absence of signs of progressive disease, persistance of megakaryocyte hyperplasia. No response: any response that does not satisfy partial remission. Progressive Disease: transformation in PET-MF, MDS or acute leukemia. |
| Secondary | Time to Treatment Discontinuation | 98 weeks | Defined as the time when treatment is discontinued |
| Secondary | Duration of Response | 142 weeks | Defined as measurement of response from the onset of response to the loss of response for responders. |
| Secondary | Proportion of Subjects Who Achieve Reduction of Platelet Counts to < 600 × 10^9/L | Between 32 and 52 weeks | Defined as Proportion of subjects who achieve reduction of platelet counts to \< 600 × 10\^9/L for at least 80% of biweekly measurements for a consecutive 12-week period between Weeks 32 and 52. |
| Secondary | Proportion of Subjects Who Achieve a Reduction of WBC Counts to < 10 × 109/L | 52 weeks | Defined as Proportion of subjects who achieve a reduction of WBC counts to \< 10 × 109/L for at least 80% of biweekly measurements for a consecutive 12-week period between Weeks 32 and 52. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Subjects Who Achieve Platelet and White Blood Cell (WBC) Control | 52 weeks | The intent-to-treat (ITT) population will include subjects randomized in the study | proportion of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Baseline through the end of randomized period -up to 14 months per participant | The safety population includes all randomized subjects who received at least 1 dose of study drug. AE has been summarized only in randomized period. End of randomized period is defined as the earliest of discontinuation or the individual unblinding date. | participants | NUMBER |
| SECONDARY | Proportion of Subjects Who Achieve Complete Remission or Partial Remission | 32 weeks | The intent-to-treat (ITT) population will include subjects randomized in the study | proportion of participants | NUMBER |
| SECONDARY | Time to Treatment Discontinuation | 98 weeks | The intent-to-treat (ITT) population will include subjects randomized in the study | Days | MEAN |
| SECONDARY | Duration of Response | 142 weeks | The intent-to-treat (ITT) population who are responders | Days | NUMBER |
| SECONDARY | Proportion of Subjects Who Achieve Reduction of Platelet Counts to < 600 × 10^9/L | Between 32 and 52 weeks | The intent-to-treat (ITT) population will include subjects randomized in the study | Proportion of participants | NUMBER |
| SECONDARY | Proportion of Subjects Who Achieve a Reduction of WBC Counts to < 10 × 109/L | 52 weeks | The intent-to-treat (ITT) population will include subjects randomized in the study | Proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Subjects Who Achieve Platelet and White Blood Cell (WBC) Control | Group A : Ruxolitinib and Anagrelide Placebo | 0 | proportion of participants | ||
| Proportion of Subjects Who Achieve Platelet and White Blood Cell (WBC) Control | Group B : Anagrelide and Ruxolitinib PLacebo | 0.17 | proportion of participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Group A : Ruxolitinib and Anagrelide Placebo | 5 | participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Group B : Anagrelide and Ruxolitinib PLacebo | 4 | participants | ||
| Proportion of Subjects Who Achieve Complete Remission or Partial Remission | Group A : Ruxolitinib and Anagrelide Placebo | 0 | proportion of participants | ||
| Proportion of Subjects Who Achieve Complete Remission or Partial Remission | Group B : Anagrelide and Ruxolitinib Placebo | 0.17 | proportion of participants | ||
| Time to Treatment Discontinuation | Group A : Ruxolitinib and Anagrelide Placebo | 261.2 | Standard Deviation 238.85 | Days | |
| Time to Treatment Discontinuation | Group B : Anagrelide and Ruxolitinib Placebo | 437.2 | Standard Deviation 183.99 | Days | |
| Duration of Response | Group B : Anagrelide and Ruxolitinib PLacebo | 442 | Days | ||
| Proportion of Subjects Who Achieve Reduction of Platelet Counts to < 600 × 10^9/L | Group A : Ruxolitinib and Anagrelide Placebo | 0 | Proportion of participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A : Ruxolitinib and Anagrelide Placebo | 6 | |
| Overall Study | STARTED | Group B : Anagrelide and Ruxolitinib Placebo | 6 | |
| Overall Study | COMPLETED | Group A : Ruxolitinib and Anagrelide Placebo | 0 | |
| Overall Study | COMPLETED | Group B : Anagrelide and Ruxolitinib Placebo | 0 | |
| Overall Study | NOT COMPLETED | Group A : Ruxolitinib and Anagrelide Placebo | 6 | |
| Overall Study | NOT COMPLETED | Group B : Anagrelide and Ruxolitinib Placebo | 6 |
Source ClinicalTrials.gov
Adverse events94
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 | Abdominal pain | Gastrointestinal disorders | Group A : Ruxolitinib and Anagrelide Placebo | 0 | 5 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Group B : Anagrelide and Ruxolitinib Placebo | 1 | 6 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Group A : Ruxolitinib and Anagrelide Placebo | 1 | 5 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Group B : Anagrelide and Ruxolitinib Placebo | 0 | 6 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Group A : Ruxolitinib and Anagrelide Placebo | 2 | 5 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Group B : Anagrelide and Ruxolitinib Placebo | 0 | 6 | 0 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Group A : Ruxolitinib and Anagrelide Placebo | 0 | 5 | 0 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Group B : Anagrelide and Ruxolitinib Placebo | 1 | 6 | 1 |
| other | Aspartate aminotransferase increased | Investigations | Group A : Ruxolitinib and Anagrelide Placebo | 1 | 5 | 2 |
| other | Aspartate aminotransferase increased | Investigations | Group B : Anagrelide and Ruxolitinib Placebo | 0 | 6 | 0 |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A : Ruxolitinib and Anagrelide Placebo | 0 | 5 |
| Total, all-cause mortality | Group B : Anagrelide and Ruxolitinib Placebo | 0 | 6 |
| Total, other adverse events | Group A : Ruxolitinib and Anagrelide Placebo | 5 | 5 |
| Total, other adverse events | Group B : Anagrelide and Ruxolitinib Placebo | 4 | 6 |
| Total, serious adverse events | Group A : Ruxolitinib and Anagrelide Placebo | 0 | 5 |
| Total, serious adverse events | Group B : Anagrelide and Ruxolitinib Placebo | 1 | 6 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group A : Ruxolitinib and Anagrelide Placebo vs Group B : Anagrelide and Ruxolitinib Placebo: deaths from any cause | Trial comparisons |
| Group A : Ruxolitinib and Anagrelide Placebo vs Group B : Anagrelide and Ruxolitinib PLacebo: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Trial comparisons |
| Group A : Ruxolitinib and Anagrelide Placebo vs Group B : Anagrelide and Ruxolitinib Placebo: serious adverse events | Trial comparisons |
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/NCT03123588
GET https://conductscience.org/api/trials/v1/NCT03123588/events?page=2