Open-Label phase 1 study to assess the aaximum tolerated dose, Pharmacokinetics, and Safety of Ixazomib administered intravenously to pediatric patients Aged 0 to <18 years with relapsed or refractory aAcute Lymphoblastic Leukemia, with or without Extramedullary Disease, or welapsed or Refractory Lymphoblastic Lymphoma

About this Study

This study is to determine the maximum tolerated dose and/or recommended phase 2 dose of intravenous ixazomib when given in combination with reinducing chemotherapy in pediatric patients with relapsed or refractory ALL or LLy. To identify the safety and toxicity of intravenous ixazomib in combination with reinduction chemotherapy in those same patients. To characterize the pharmacokientics of IV ixazomib in combination with reinduction chemotherapy in those same patients.

Sponsor Protocol ID:C16051
IRB Number:2019-0190
Actively Enrolling
Phase 1
August 26, 2019
Eligibility Criteria
18 years old
Both Male and Female

Inclusion Criteria Age

Exclusion Criteria

 Have a planned administration of chemotherapy, radiation therapy, or immunotherapy, other than the study drugs used for this protocol (during the study period). 
 Have Down syndrome. 
 Have received any investigational products within 28 days before the first dose of study treatment. 
 Pregnancy and breastfeeding exclusions: 
 Female patients who are pregnant are excluded because fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential. 
 Lactating females who plan to breastfeed their infants are excluded. 
 Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation. 
 Major surgery within 10 days before the first dose of study drug.

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Participating Locations
Children’s of Mississippi Hospital - Blair E. Batson Tower
Contact Information
Contact Name: Julie Hornaday
Phone Number: 601-984-2712
Principal Investigator:Collier, Anderson B, M.D.
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