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 — OTHER
    Correlative studies
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Ruxolitinib Phosphate — DRUG
    Given 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)

FacilityCityStateZIPSite coordinators
Stanford Cancer Institute Palo AltoPalo AltoCalifornia94304-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
Washington University School of MedicineSt LouisMissouri63110-
OHSU Knight Cancer InstitutePortlandOregon97239-
UT Southwestern/Simmons Cancer Center-DallasDallasTexas75390-
M D Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-

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