A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway Mutant Acute Lymphoblastic Leukemia

Recruiting
1 years - 21 years
All
Phase N/A
1 Location

Brief description of study

The purpose of this study is to find the best dose of ruxolitinib to use with standard chemotherapy in children, adolescents, and young adults with HR B-ALL; and to find out if the investigational drug ruxolitinib helps chemotherapy to work better and to compare the effects, good and/or bad, of using ruxolitinib with chemotherapy.

Detailed description of study

The purpose of this study is to find the best dose of ruxolitinib to use with standard chemotherapy in children, adolescents, and young adults with HR B-ALL; and to find out if the investigational drug ruxolitinib helps chemotherapy to work better and to compare the effects, good and/or bad, of using ruxolitinib with chemotherapy.

Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: acute lymphoblastic leukemia,lymphoblastic leukemia,lymphoblastic,leukemia,JAK pathway,JAK,pediatric,riley,childhood,children,child,kid,kids,teen,teens,teenager,teenagers,youth,adolescent
  • Age: 1 years - 21 years
  • Gender: All

Inclusion Criteria
De novo high-risk (HR) Ph-like B-ALL for which any of following criteria are present at diagnosis:
Age ? 10 years
White blood cell (WBC) ? 50 ? 10^3/?L
CNS3 leukemia
One of the following Ph-like ALL genetic lesions must be present in the diagnostic bone marrow or peripheral blood sample:
CRLF2 rearrangement with JAK1 or JAK2 mutation (JAK+)
CRLF2 rearrangement without JAK mutation
Other JAK pathway alterations (eg, JAK2 fusions, erythropoietin receptor (EPO-R) fusions, SH2B3 deletions, interleukin-7 receptor-alpha (IL7RA) mutations) with or without CRLF2 rearrangement
Completed a 4-drug Induction therapy regimen (modified aBFM regimen or equivalent) in Study AALL1131 or as the institutional standard of care for HR B-ALL and have had end-Induction minimal residual disease (MRD) assessed
Male and female subjects of reproductive non childbearing potential or willing to take appropriate precautions to avoid pregnancy or fathering a child for the duration of study participation
Exclusion Criteria
Receipt of any other cytotoxic chemotherapy before Induction therapy (except pre-Induction hydroxyurea or steroid pretreatment)
BCR-ABL1-rearranged ALL
Trisomy 21 (Down syndrome)
History or evidence of cirrhosis
Positive screen for hepatitis B or C
Known human immunodeficiency virus infection

Updated on 04 Aug 2024. Study ID: 1610845060 (PHO-FALON-INCYTE-AALL1521)

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