18 and older, any sex, with Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative or Chronic Neutrophilic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of First 25 Enrolled Patients With a Hematologic Response to Ruxolitinib (Complete Response (CR), Partial Response (PR))Primary· 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
Protocol-defined Response
Group
Value
95% CI
First 25 Enrolled Subjects
32
15 – 54
IWG-defined Response
Group
Value
95% CI
First 25 Enrolled Subjects
4
0.1 – 20
Percentage of Participant With Any Hematologic Grade III or IV Adverse Events.Secondary· 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
Group
Value
95% CI
Treatment (Ruxolitinib Phosphate)
46.9
32.5 – 61.7
Percentage of Participants With Any Non-hematologic Grade III or IV Adverse Events.Secondary· 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
Group
Value
95% CI
Treatment (Ruxolitinib Phosphate)
69.4
54.6 – 81.7
Percentage of Participants Who Achieved Clinical Response of Partial Response or BetterSecondary· 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,
Protocol-defined Response
Group
Value
95% CI
Treatment (Ruxolitinib Phosphate)
33
20 – 48
IWG-defined Response
Group
Value
95% CI
Treatment (Ruxolitinib Phosphate)
8
2.3 – 20
Median Time on Study (Months) for Early Drop OffsSecondary· End of cycle 6
Median and range of months on study for subjects who did not complete 6 cycles of Ruxolitinib
Group
Value
95% CI
Treatment (Ruxolitinib Phosphate)
2.4
.2 – 5.7
Median Time on Study (Months) for All Enrolled SubjectsSecondary· 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
Group
Value
95% CI
Treatment (Ruxolitinib Phosphate)
8.5
.2 – 50.5
Percentage of Participants With Early Drop Off (Prior to Completion of Cycle 3)Secondary· 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
Group
Value
95% CI
Treatment (Ruxolitinib Phosphate)
16
7.3 – 30
Percentage of Participants Who Reach Cycle 7Secondary· Start of cycle 7
Report percent (and 95% confidence interval) of subjects who start cycle 7(complete cycle 6)
Group
Value
95% CI
Treatment (Ruxolitinib Phosphate)
65
50 – 78
Percentage of Participants With Early Drop Off (After Completion of Cycle 3 and Prior to Completion of Cycle 6)Secondary· 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
Group
Value
95% CI
Treatment (Ruxolitinib Phosphate)
18
8.8 – 32
Maximum Clinical ResponsesSecondary· 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% reducti
Complete Response (CR)
Group
Value
95% CI
Treatment (Ruxolitinib Phosphate)
8
2.3 – 20
Partial Response (PR)
Group
Value
95% CI
Treatment (Ruxolitinib Phosphate)
24
13 – 39
Stable Disease (SD)
Group
Value
95% CI
Treatment (Ruxolitinib Phosphate)
29
17 – 43
Progressive Disease (PD)
Group
Value
95% CI
Treatment (Ruxolitinib Phosphate)
37
23 – 52
Change in Spleen Size, Evaluated by UltrasoundSecondary· Measured on Day1 Cycle 1 and Day 1 Cycle 7
Change in spleen size (median, range) evaluated by ultrasound at the start of cycle 7 (day 1, cycle 7) and the start of study (day 1, cycle 1). Spleen volume is calculated by the conventional prolate ellipsoid method. Measure spleen width, thickness and maximum length in centimeters. Multiply width by thickness by max length by 0.524 to get the total spleen volume in cm\^3. Spleen size is only one component of protocol-defined response and cannot be used to independently assess response. (see section 10.6, Clinical Response, Table 6 of attached study protocol) Change in spleen size is the diff
Group
Value
95% CI
Treatment (Ruxolitinib Phosphate)
-219.7
-1553.8 – 1061.4
Change in Symptom Score as Measured by a Modified Myeloproliferative Neoplasm Symptom Assessment Form [MPN-SAF]Secondary· Measured at baseline and Day 1 Cycle 7
Myeloproliferative Neoplasm Symptom Assessment Form Total symptom score (MPN-SAF TSS) ranges from 0 (no symptoms) to 10 (worst imaginable symptoms). The score is a sum of 10 independent measurements, generating a final score ranging from 0 - 100 and collected at baseline and on day 1, cycle 7. Change in total symptom score (TSS Median, range) is reported for those achieving day 1, cycle 7 AND responding to all 10 survey questions at baseline and Day 1, Cycle 7. Change in TSS is calculated as score on Day 1 Cycle 7 minus score at baseline.
Group
Value
95% CI
Treatment (Ruxolitinib Phosphate)
-3.0
-37.0 – 8.0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events (AE) were collected from first dose of ruxolitinib until 30 days after last dose. Any AEs occurring more than 30 days after the last dose of study drug and believed related to study drug were reported. Study drug was administered up to 96 weeks. Patients receiving ongoing clinical benefit were eligible to continue receiving study drug (up to 5 years)..
Reporting threshold: 2.5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (Ruxolitinib Phosphate)
Serious: 30/49 (61%)
Deaths: 36/49
Serious adverse events (53 terms)
Reaction
System
Treatment (Ruxolitinib Pho…
Lung infection
Infections and infestations
—
Pneumonitis
Respiratory, thoracic and mediastinal disorders
—
Anemia
Blood and lymphatic system disorders
—
Heart failure
Cardiac disorders
—
Leukocytosis
Blood and lymphatic system disorders
—
Acute kidney injury
Renal and urinary disorders
—
Death NOS
General disorders
—
Hematoma
Vascular disorders
—
Upper respiratory infection
Infections and infestations
—
Back pain
Musculoskeletal and connective tissue disorders
—
Fatigue
General disorders
—
Gastrointestinal disorders - Other, Specify
Gastrointestinal disorders
—
Infections and infestations - Other, Specify
Infections and infestations
—
Platelet count decreased
Investigations
—
Skin infection
Infections and infestations
—
Urinary tract infection
Infections and infestations
—
Abdominal pain
Gastrointestinal disorders
—
Anxiety
Psychiatric disorders
—
Avascular necrosis
Musculoskeletal and connective tissue disorders
—
Blood and lymphatic system disorders - Other, Specify
This phase II trial studies how well ruxolitinib phosphate works in treating patients with chronic neutrophilic leukemia (CNL) or atypical chronic myeloid leukemia (aCML). Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cells to reproduce. This trial also studies the genetic makeup of patients. Certain genes in cancer cells may determine how the cancer grows or spreads and how it may respond to different drugs. Studying how the genes associated with CNL and aCML respond to the study drug may help doctors learn more about CNL and aCML and improve the treatment for these diseases.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT04142385 — Incidence of HIV Infection in Screening Indian Men Who Have Sex With Men
· withdrawn
NCT05558904 — An Investigational Scan (Me-4FDG PET/CT) for the Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cance
· Phase 1, PHASE2
· recruiting
NCT05564650 — Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome
· Phase 1
· active not recruiting
NCT05396859 — Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia
· Phase 1
· active not recruiting
Other recruiting trials for Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Currently open trials in the same condition.
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Other OHSU Knight Cancer Institute trials
Trials by the same sponsor.
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· not yet recruiting
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NCT07504835 — GET FIT Together: Testing a Socially Enhanced Exercise Program in Older Men With Prostate Cancer
· NA
· not yet recruiting
NCT07498517 — Safety and Efficacy of a Single Dose of Gruticibart to Prevent CRT
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· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by OHSU Knight Cancer Institute
Last refreshed: 16 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02092324.