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

Overview

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.

Description

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

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

  • Conditions: acute lymphoblastic leukemia
  • Age: Between 1 Years - 21 Years
  • Gender: Male or Female

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


Additional Information:
Participants will not be paid for their participation.

Updated on 30 Nov 2022 . Study ID: TX7198

Connect with a study center near you

What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Contact a study center