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New treatment option for BCR-JAK2 Fusion Protein Expression
Official title Ruxolitinib in Treating Patients With Hypereosinophilic Syndrome or Primary Eosinophilic Disorders
ClinicalTrials.gov ID: NCT03801434
What this study is testing
What is Ruxolitinib?
Ruxolitinib is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for bcr-jak2 fusion protein expression.
Also referred to as INCB-18424, INCB18424.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial studies how well ruxolitinib works in treating patients with hypereosinophilic syndrome or primary eosinophilic disorders.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject with idiopathic hypereosinophilic syndrome must meet the following:
- Has as at least 2 readings with an absolute eosinophil count \>= 1,500/mm\^3 in the preceding 3 months prior to starting ruxolitinib (one reading...
- Dependent, intolerant or refractory to corticosteroids OR has relapsed/refractory disease to other therapy besides corticosteroids.
- Symptomatic from his/her disease OR has one or more signs of organ damage (assessed by the investigator as possibly-related to eosinophilia or...
- Subject with lymphocyte-variant hypereosinophilia must meet the following
You likely can't join if
- Active life-threatening complication(s) from underlying eosinophilic disease (i.e., leukostasis; acute thromboembolic disease including central...
- World Health Organization (WHO)-defined myeloid neoplasm associated with eosinophilia other than CEL NOS and JAK2 rearranged neoplasms (e.g...
- Reactive hypereosinophilia due to connective tissue disease, sarcoidosis or eosinophilic granulomatosis with polyangiitis.
- Organ-restricted ?tissue? eosinophilia with the absence of peripheral eosinophilia in the blood.
- Invasive malignancy over the previous 2 years except treated early stage carcinomas of the skin, completely resected intraepithelial carcinoma of the...
- Myeloid or lymphoid neoplasm with eosinophilia and abnormalities of PDGFRA, PDGFRB or FGFR1.
See the full eligibility criteria
Who can join
- Subject with idiopathic hypereosinophilic syndrome must meet the following:
- Has as at least 2 readings with an absolute eosinophil count \>= 1,500/mm\^3 in the preceding 3 months prior to starting ruxolitinib (one reading must be during the screening period).
- Dependent, intolerant or refractory to corticosteroids OR has relapsed/refractory disease to other therapy besides corticosteroids.
- Symptomatic from his/her disease OR has one or more signs of organ damage (assessed by the investigator as possibly-related to eosinophilia or biopsy-proven). This can include skin, lung, cardiac, central nervous...
- Subject with lymphocyte-variant hypereosinophilia must meet the following
- Has at least 2 readings with an absolute eosinophil count \>= 1,500/mm\^3 in the preceding 3 months prior to starting ruxolitinib (one reading must be during the screening period).
- Dependent, intolerant or refractory to corticosteroids\ OR has relapsed/refractory disease to other therapy besides corticosteroids.
- Symptomatic from his/her disease OR has one or more signs of organ damage (assessed by the investigator as possibly-related to eosinophilia or biopsy-proven). This can include skin, lung, cardiac, central nervous...
- Has abnormal T-lymphocyte immuno-phenotype by flow cytometry.
- Subject with chronic eosinophilic leukemia, not otherwise specified (CEL,NOS) must meet the following
- Has at least 2 readings with an absolute eosinophil count \>= 500/mm\^3 in the preceding 3 months prior to starting ruxolitinib (one reading must be during the screening period).
- Newly-diagnosed OR receiving corticosteroids OR has relapsed/refractory disease to any therapy besides corticosteroids.
- Has increased blasts in the blood or bone marrow (\> 5% and \< 20%), and/or a clonal cytogenetic or molecular abnormality
- people with JAK2 mutations are included within this group.
- Subject with JAK2-rearranged eosinophilic neoplasm must meet the following
- Has at least 2 readings with an absolute eosinophil count \>= 500/mm\^3 in the preceding 3 months prior to starting ruxolitinib (one reading must be during the screening period).
- Newly-diagnosed OR receiving corticosteroids OR has relapsed/refractory disease to any therapy besides corticosteroids.
- This group includes people with PCM1-JAK2, BCR-JAK2, ETV6-JAK2 or other JAK2 rearrangements.
- If receiving corticosteroids, must be a stable dose for \>= 28 days prior to Day 1 (unstable dosing not eligible).
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 3.
- Willing and able to review and execute informed consent (legally-authorized consent acceptable).
What rules you out
- Active life-threatening complication(s) from underlying eosinophilic disease (i.e., leukostasis; acute thromboembolic disease including central nervous system (CNS) involvement; severe pulmonary or cardiac dysfunction)...
- World Health Organization (WHO)-defined myeloid neoplasm associated with eosinophilia other than CEL NOS and JAK2 rearranged neoplasms (e.g., myelodysplastic syndrome (MDS); myeloproliferative neoplasms (MPN); MDS/MPN...
- Reactive hypereosinophilia due to connective tissue disease, sarcoidosis or eosinophilic granulomatosis with polyangiitis.
- Organ-restricted ?tissue? eosinophilia with the absence of peripheral eosinophilia in the blood.
- Invasive malignancy over the previous 2 years except treated early stage carcinomas of the skin, completely resected intraepithelial carcinoma of the cervix, and completely resected papillary thyroid and follicular...
- Myeloid or lymphoid neoplasm with eosinophilia and abnormalities of PDGFRA, PDGFRB or FGFR1.
- Anticipated to receive a hematopoietic stem cell transplant within the first 6 months of treatment on trial.
- Major surgery within 4 weeks prior to entering the study.
- Life expectancy of \< 6 months.
- Known diagnosis of human immunodeficiency virus (HIV).
- Known diagnosis of chronic active hepatitis B or C (viral testing is not required). people with a known history of hepatitis B and/or C are allowed on trial if at the time of enrollment, the virus is not active and...
- Clinically serious infections requiring ongoing antibiotic therapy.
- Parasitic infection diagnosed within 24 weeks prior to enrollment.
- Platelet count =\< 25 x 10\^9/L at baseline.
- Alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) \> 4 x upper limit of normal (ULN) or direct bilirubin \> 4 x ULN (if considered to be unrelated to the underlying eosinophilic disorder).
- End-stage renal function (creatinine clearance [CrCl] \< 15 mL/min or glomerular filtration rate [GFR] \< 15 mL/min) regardless of whether hemodialysis is required.
- Use of investigational or commercial therapies with the intent to treat the underlying eosinophilic disorder within 28 days of study start, including interferon; imatinib; alemtuzumab; cyclosporine; methotrexate...
- Use of hydroxyurea within 7 days of study start.
- Prior therapy with ruxolitinib or other JAK inhibitors.
- Previous allergic reactions to JAK inhibitors or excipients.
- Unwilling to commit to abstinence from heterosexual contact or agree to use and comply with highly effective contraception, 28 days prior to starting study drug, during the treatment period and for 12 weeks after...
- Females of childbearing potential who have a positive pregnancy test (urine or serum) during screening period.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Portland, Oregon, United States
- Salt Lake City, Utah, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Portland, Oregon, United States; Salt Lake City, Utah, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.