An Open-Label, Multicenter Study of RC-P in Patients with Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) Following Hypersensitivity to E. coli-derived Asparaginases

About this Study

This study is being done to learn more about how the body handles the drug RC-P and to learn about the side effects.

Sponsor Protocol ID:IND 129622
IRB Number:2019-0282
Actively Enrolling
Interventional
Phase 2
January 27, 2020
Eligibility Criteria
Both Male and Female
Yes
Yes
No

Inclusion CriteriaEach patient must meet the following criteria to be enrolled in this study: 

1. Able to understand and to sign a written informed consent, and/or have their parent or a legally authorized representative sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.

2. Female subjects of childbearing potential (ie, fertile, following menarche) and male subjects who have female partners of childbearing potential must agree to use medically acceptable methods of contraception with their partners from Screening, throughout the study, and for 30 days after the last dose of RC-P. Medically acceptable methods of contraception that may be used by the subject include abstinence (when this is in line with the preferred and usual lifestyle of the patient), progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action; combination of male condom with either cap, diaphragm, or sponge with spermicide (double barrier methods).  

Exclusion Criteria1. Pregnant or lactating females or females of childbearing potential not willing to use a medically acceptable of birth control for the duration of the study. Female patients who are lactating and do not agree to stop breast-feeding.

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Cancer
Participating Locations
Batson Children’s Hospital
Contact Information
Contact Name: Julie Hornaday
Phone Number: 601-984-2712
Email: jhornaday@umc.edu
Principal Investigator:Collier, Anderson B, M.D.
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