Trial · NCT02092324
Ruxolitinib Phosphate in Treating Patients With Chronic Neutrophilic Leukemia or Atypical Chronic Myeloid Leukemia
NCT02092324, Phase 2, Completed, OHSU Knight Cancer Institute; results first posted 2020-11-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ruxolitinib Phosphate in Treating Patients With Chronic Neutrophilic Leukemia or Atypical Chronic Myeloid Leukemia. Trials, record NCT02092324. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02092324
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ruxolitinib Phosphate in Treating Patients With Chronic Neutrophilic Leukemia or Atypical Chronic Myeloid Leukemia
- NCT number
- NCT02092324
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- OHSU Knight Cancer Institute
- Conditions
- Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Chronic Neutrophilic Leukemia
- Interventions
- Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration, Ruxolitinib Phosphate
- First posted
- 2014-03-20
- Last updated
- 2020-11-16
- Results first posted
- 2020-11-16
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of First 25 Enrolled Patients With a Hematologic Response to Ruxolitinib (Complete Response (CR), Partial Response (PR)) | Start of cycle 7 | A subject is defined as being responsive (responder) if he or she has achieved complete response (CR) or partial response (PR) at the beginning of cycle 7 compared to start of study (day 1,cycle 1). Subjects who do not reach the start of cycle 7 are counted as non-responders. Proportions with 95% exact confidence intervals will be computed. Protocol-defined Response evaluates changes in white blood cell count, absolute neutrophil count, marrow findings and spleen size to define response (attached protocol, Section 10.6, Clinical Response, Table 6 and Table). IWG-defined Response evaluates bone marrow cellularity and myeloblast percent, absence of osteopmyelofibrosis, peripheral blood elements (white blood cell, Neutrophil, Monocyte and platelet counts, hemoglobin density, percent blasts and Neutrophil precursors), symptom resolution, dysplasia, and spleen size to determine response (attached reference). |
| Secondary | Percentage of Participant With Any Hematologic Grade III or IV Adverse Events. | Up to 6 weeks after last dose of ruxolitinib phosphate | The frequency (percentage) of subjects with any hematologic \[thrombocytopenia, anemia or neutropenia\] grade III or IV adverse events according to CTCAE v4.0 |
| Secondary | Percentage of Participants With Any Non-hematologic Grade III or IV Adverse Events. | Up to 6 weeks after last dose of ruxolitinib phosphate | The frequency (percentage) of subjects with any non-hematologic grade III or IV adverse events according to CTCAE v4.0 |
| Secondary | Percentage of Participants Who Achieved Clinical Response of Partial Response or Better | Start of cycle 7 | Compute the percent of patients with protocol-defined objective response (CR+PR) and IWG-defined objective response (CR+PR) at the start of cycle 7 among all enrolled patients (n = 49). Patients who withdrew prior to the end of cycle 6 are considered non-responders. Protocol-defined Response evaluates changes in white blood cell count, absolute neutrophil count, marrow findings and spleen size to define response (attached protocol, Section 10.6, Clinical Response, Table 6 and Table). IWG-defined Response evaluates bone marrow cellularity and myeloblast percent, absence of osteopmyelofibrosis, peripheral blood elements (white blood cell, Neutrophil, Monocyte and platelet counts, hemoglobin density, percent blasts and Neutrophil precursors), symptom resolution, dysplasia, and spleen size to determine response (attached reference). |
| Secondary | Median Time on Study (Months) for Early Drop Offs | End of cycle 6 | Median and range of months on study for subjects who did not complete 6 cycles of Ruxolitinib |
| Secondary | Median Time on Study (Months) for All Enrolled Subjects | Outcome is measured from the first dose of study drug. If study drug continues to be effective, patient may be eligible to continue on study drug past 24 cycles (up to 4.5 years) | Median and range of months on Ruxolitinib for all enrolled subjects |
| Secondary | Percentage of Participants With Early Drop Off (Prior to Completion of Cycle 3) | up to the end of cycle 3 (12 weeks) | Percent (and 95% confidence interval) of subjects who discontinue Ruxolitinib prior to completion of cycle 3 |
| Secondary | Percentage of Participants Who Reach Cycle 7 | Start of cycle 7 | Report percent (and 95% confidence interval) of subjects who start cycle 7(complete cycle 6) |
| Secondary | Percentage of Participants With Early Drop Off (After Completion of Cycle 3 and Prior to Completion of Cycle 6) | Between cycle 3 and cycle 6 | Percent (and 95% confidence interval) of subjects who discontinue after completion of 3 cycles but prior to completion of 6 cycles |
| Secondary | Maximum Clinical Responses | Up to 6 weeks after last dose of ruxolitinib phosphate | Percent (and 95% confidence interval) of subjects' maximum or "best" protocol-defined response \[CR \> PR \> SD \> PD\]. Protocol-defined Response combines changes in white blood cell count, absolute neutrophil count, marrow findings and spleen size to define response (attached protocol, Section 10.6, Clinical Response, Table 6 and Table). Duration of maximum response was not available from the final data set. PR requires \> 50% reduction in white blood cell and absolute neutrophil counts, \> 50% reduction in granulocytic hyperplasia (CNL) or granulocytic dyspoiesis (aCML), and \> 25% reduction in spleen size. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of First 25 Enrolled Patients With a Hematologic Response to Ruxolitinib (Complete Response (CR), Partial Response (PR)) | Start of cycle 7 | First 25 enrolled subjects enrolled, received at least one dose of study drug, and were evaluated for protocol-defined and International Working Group (IWG) defined objective response | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participant With Any Hematologic Grade III or IV Adverse Events. | Up to 6 weeks after last dose of ruxolitinib phosphate | All subjects receiving at least one dose of ruxolitinib | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Any Non-hematologic Grade III or IV Adverse Events. | Up to 6 weeks after last dose of ruxolitinib phosphate | All subjects receiving at least one dose of ruxolitinib | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Clinical Response of Partial Response or Better | Start of cycle 7 | All enrolled subjects who receive at least one dose of ruxolitinib. Subjects who withdraw prior to the start of cycle 7 are considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Median Time on Study (Months) for Early Drop Offs | End of cycle 6 | Enrolled subjects who received at least one dose of study drug but did not complete 6 full cycles of Ruxolitinib | months | MEDIAN |
| SECONDARY | Median Time on Study (Months) for All Enrolled Subjects | Outcome is measured from the first dose of study drug. If study drug continues to be effective, patient may be eligible to continue on study drug past 24 cycles (up to 4.5 years) | Enrolled subjects who received at least one dose of Ruxolitinib | months | MEDIAN |
| SECONDARY | Percentage of Participants With Early Drop Off (Prior to Completion of Cycle 3) | up to the end of cycle 3 (12 weeks) | Enrolled subjects who received at least one dose of Ruxolitinib | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Reach Cycle 7 | Start of cycle 7 | Enrolled subjects who received at least one dose of Ruxolitinib | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Early Drop Off (After Completion of Cycle 3 and Prior to Completion of Cycle 6) | Between cycle 3 and cycle 6 | Enrolled subjects who received at least one dose of Ruxolitinib | percentage of participants | NUMBER |
| SECONDARY | Maximum Clinical Responses | Up to 6 weeks after last dose of ruxolitinib phosphate | All enrolled subjects who received at least one dose of ruxolitinib. Subject who withdraw prior to disease response evaluation are considered non-responders (PD). One subject who was inevaluable for response was included in the denominator. | percentage of participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of First 25 Enrolled Patients With a Hematologic Response to Ruxolitinib (Complete Response (CR), Partial Response (PR)) | First 25 Enrolled Subjects | Protocol-defined Response | 32 | 95% Confidence Interval 15 to 54 | percentage of participants |
| Percentage of First 25 Enrolled Patients With a Hematologic Response to Ruxolitinib (Complete Response (CR), Partial Response (PR)) | First 25 Enrolled Subjects | IWG-defined Response | 4 | 95% Confidence Interval 0.1 to 20 | percentage of participants |
| Percentage of Participant With Any Hematologic Grade III or IV Adverse Events. | Treatment (Ruxolitinib Phosphate) | 46.9 | 95% Confidence Interval 32.5 to 61.7 | percentage of participants | |
| Percentage of Participants With Any Non-hematologic Grade III or IV Adverse Events. | Treatment (Ruxolitinib Phosphate) | 69.4 | 95% Confidence Interval 54.6 to 81.7 | percentage of participants | |
| Percentage of Participants Who Achieved Clinical Response of Partial Response or Better | Treatment (Ruxolitinib Phosphate) | Protocol-defined Response | 33 | 95% Confidence Interval 20 to 48 | percentage of participants |
| Percentage of Participants Who Achieved Clinical Response of Partial Response or Better | Treatment (Ruxolitinib Phosphate) | IWG-defined Response | 8 | 95% Confidence Interval 2.3 to 20 | percentage of participants |
| Median Time on Study (Months) for Early Drop Offs | Treatment (Ruxolitinib Phosphate) | 2.4 | Full Range .2 to 5.7 | months | |
| Median Time on Study (Months) for All Enrolled Subjects | Treatment (Ruxolitinib Phosphate) | 8.5 | Full Range .2 to 50.5 | months | |
| Percentage of Participants With Early Drop Off (Prior to Completion of Cycle 3) | Treatment (Ruxolitinib Phosphate) | 16 | 95% Confidence Interval 7.3 to 30 | percentage of participants | |
| Percentage of Participants Who Reach Cycle 7 | Treatment (Ruxolitinib Phosphate) | 65 | 95% Confidence Interval 50 to 78 | percentage of participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Ruxolitinib Phosphate) | 51 | |
| Overall Study | End of Cycle 6 | Treatment (Ruxolitinib Phosphate) | 25 | |
| Overall Study | Wildtype CSF3R | Treatment (Ruxolitinib Phosphate) | 23 | |
| Overall Study | Mutant CSF3R | Treatment (Ruxolitinib Phosphate) | 26 | |
| Overall Study | COMPLETED | Treatment (Ruxolitinib Phosphate) | 32 | |
| Overall Study | NOT COMPLETED | Treatment (Ruxolitinib Phosphate) | 19 |
Source ClinicalTrials.gov
Adverse events60
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 | Anemia | Blood and lymphatic system disorders | Treatment (Ruxolitinib Phosphate) | 16 | 49 | 28 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Ruxolitinib Phosphate) | 1 | 49 | 2 |
| other | Fatigue | General disorders | Treatment (Ruxolitinib Phosphate) | 2 | 49 | 3 |
| other | Hyponatremia | Metabolism and nutrition disorders | Treatment (Ruxolitinib Phosphate) | 3 | 49 | 3 |
| other | Leukocytosis | Blood and lymphatic system disorders | Treatment (Ruxolitinib Phosphate) | 4 | 49 | 5 |
| other | Lymphocyte count decreased | Investigations | Treatment (Ruxolitinib Phosphate) | 3 | 49 | 5 |
| other | Platelet count decreased | Investigations | Treatment (Ruxolitinib Phosphate) | 7 | 49 | 11 |
| serious | Abdominal pain | Gastrointestinal disorders | Treatment (Ruxolitinib Phosphate) | 1 | 49 | 1 |
| serious | Acute kidney injury | Renal and urinary disorders | Treatment (Ruxolitinib Phosphate) | 3 | 49 | 3 |
| serious | Anemia | Blood and lymphatic system disorders | Treatment (Ruxolitinib Phosphate) | 4 | 49 | 4 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Ruxolitinib Phosphate) | 36 | 49 |
| Total, other adverse events | Treatment (Ruxolitinib Phosphate) | 27 | 49 |
| Total, serious adverse events | Treatment (Ruxolitinib Phosphate) | 30 | 49 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA069533 | OHSU Knight Cancer Institute | KUMMAR, SHIVAANI | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1997 to 2025 |
Source NIH RePORTER
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/NCT02092324
GET https://conductscience.org/api/trials/v1/NCT02092324/results?page=2