Ruxolitinib Phosphate in Treating Patients With Chronic Neutrophilic Leukemia or Atypical Chronic Myeloid Leukemia
Part of paid clinical trials in Palo Alto, California.
- Sponsor
- OHSU Knight Cancer Institute
- Study ID
- NCT02092324
- Phase
- PHASE2
- Status
- Completed
Conditions
- Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
- Chronic Neutrophilic Leukemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Laboratory Biomarker Analysis — OTHERCorrelative studies
- Quality-of-Life Assessment — OTHERAncillary studies
- Questionnaire Administration — OTHERAncillary studies
- Ruxolitinib Phosphate — DRUGGiven PO
Study Details
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.
Key Dates
- Start date
- Jul 8, 2014
- Status verified
- Oct 2020
- Primary completion
- Nov 22, 2019
- Completion
- Jan 24, 2020
Study Design
- Enrollment
- 51 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (ruxolitinib phosphate)Patients receive ruxolitinib phosphate PO every other day, QD, or BID on days 1-28. Each patient will be followed for a maximum of 96 weeks (24 cycles, 1 cycle is 4 weeks long). If the study drug continues to be effective, the patient may be eligible to continue on study drug past 24 cycles.
Primary Outcome Measure
Percentage of First 25 Enrolled Patients With a Hematologic Response to Ruxolitinib (Complete Response (CR), Partial Response (PR)) [ Time Frame: Start of cycle 7 ]
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Stanford Cancer Institute Palo Alto | Palo Alto | California | 94304 | - |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | - |
| Washington University School of Medicine | St Louis | Missouri | 63110 | - |
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | - |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | - |
| M D Anderson Cancer Center | Houston | Texas | 77030 | - |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | - |
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