Purpose:

This research study will find out if the study drug, ruxolitinib, in combination with standard high risk B-ALL treatment is safe and effective in children, adolescents, and young adults with high risk B-ALL. High risk meaning that the patients have tested positive for having a genetic abnormality including a rearranged CRFL2 gene or mutation in the JAK1 or JAK2. Or other alterations involving the JAK pathway(such as JAK2 fusions, EPO-R fusions, SH2B3 deletions, IL7RA mutations).

Primary:

To find the best dose of ruxolitinib to use with standard chemotherapy in children, adolescents, and young adults with high risk B-ALL.

Secondary:

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.

 

Study Summary:

This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent chemotherapy regimen for the treatment of B-ALL. Approximately 4 subjects with newly diagnosed B-ALL, aged 1 to 21 years at the time of diagnosis, will be evaluated for genetic eligibility during the Induction phase of a 4 drug chemotherapy regimen. If they have the eligible genetic abnormalities they will be assigned to a cohort group and study group based upon genetic analysis depending on the time of enrollment. Toxicity will be evaluated during therapy while ruxolitinib will be co-administered. If combination therapy is found to be safe in Part 1. Then in Part 2, subjects will be evaluated for the efficacy of combination therapy with chemotherapy and ruxolitinib. The efficacy outcomes will be compared with control data.  Subject will undergo planned physical examination and laboratory monitoring that coincide with standard of care for multi-agent chemotherapy regimen. Assessments will occur weekly during the early phases of treatment and become less intensive during the later phases. Additionally, subjects will undergo long term follow-up for efficacy after the chemotherapeutic regimen is complete.

 

Basic Eligibility Criteria:

All newly diagnosed HR B-ALL patients between the age of 1 and 21 years of age with one of the PH-like chromosome genetic lesions including cytokine receptor–like factor 2 rearrangement with JAK1 or JAK2 mutation (JAK+), Cytokine receptor–like factor 2 rearrangement without JAK mutation, or other JAK pathway alterations (eg, JAK2 fusions, EPO-R fusions, SH2B3 deletions, IL7RA mutations) with or without CRLF2-R. Patients must have also completed the 4 drug regimen Induction therapy on Study AALL1131 or as standard of care for HR B-ALL.

 

Study Location(s):

Phoenix Children's Hospital

 

Study Contact(s):

Jessica Boklan MD

Sejal Patel  602-933-0203  spatel10@phoenixchildrens.com

 

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