Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leu… (NCT03571321) | Clinical Trial Compass
RecruitingPhase 1
Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia
United States15 participantsStarted 2019-05-28
Plain-language summary
This study will test if adding ruxolitinib to standard multi-drug chemotherapy regimen will be safe and tolerated in adolescents and young adults with newly diagnosed Ph-like acute lymphoblastic leukemia (ALL).
Who can participate
Age range18 Years – 39 Years
SexALL
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Inclusion Criteria:
* Newly diagnosed de novo B-precursor acute lymphoblastic leukemia (ALL) as determined by World Health Organization (WHO) criteria. Patients must have unequivocal diagnosis of precursor B ALL. This includes an institutional immunophenotyping report that is to assign B-lineage or T-lineage.
* "Ph-like" signature, as determined by low density micro-array (LDA) card
* Jak-targetable genetic signature as defined by any of the following:
* Cytokine receptor-like factor 2 (CRLF2) rearranged (JAK2 mutant or wild-type)
* JAK2 or erythropoietin receptor (EPOR) fusions.
* Other JAK pathway alterations at the discretion of the principle investigator including, but not limited to:
* SH2B adaptor protein 3 (SH2B3) deletions
* Interleukin-7 receptor subunit alpha (IL7RA) mutations
* Prior therapy
* Prior to starting ruxolitinib, patients must have completed a 4-drug induction regimen with intrathecal chemotherapy (modified aBFM regimen or equivalent) as per the institutional standard of care. Recommended induction treatment is outlined in Section 5.1.2.
* No additional prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys. When indicated, leukapheresis or exchange transfusion is recommended to reduce the white blood cell count (WBC).
* Screening may occur at any point prior to or during induction therapy
* A…
What they're measuring
1
Feasibility of adding ruxolitinib to a standard-of-care pediatric-based chemotherapy regimen in adolescents and young adult patients as determined by rate of side effects seen when combination is given