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
Investigation of Ruxolitinib with Chemotherapy for High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) in Young Patients
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.
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
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Age: 1 years - 21 years
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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
This study investigates the use of an investigational medication with standard chemotherapy in children, adolescents, and young adults who have high-risk B-cell acute lymphoblastic leukemia (HR B-ALL). HR B-ALL is a type of cancer that affects the blood and bone marrow. The purpose is to find the best dose of the investigational medication and see if it makes chemotherapy more effective.
Participants will receive either the investigational medication or a placebo along with their chemotherapy. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will compare the effects, both good and bad, of using the investigational medication with chemotherapy.
- Who can participate: Participants must be children, adolescents, or young adults diagnosed with high-risk Ph-like B-ALL. They should have completed a 4-drug induction therapy regimen and meet certain genetic criteria. Individuals with BCR-ABL1-rearranged ALL or Down syndrome are excluded.
- Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo along with standard chemotherapy.
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