An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)

  • STATUS
    Recruiting
  • End date
    Mar 21, 2021
  • participants needed
    135
  • sponsor
    Jazz Pharmaceuticals
Updated on 25 November 2020
Investigator
Associate Director Clinical Trial Disclosure
Primary Contact
Children's National Health System (5.3 mi away) Contact
+61 other location
lymphoid leukemia
lymphoma
lymphoblastic lymphoma
asparaginase

Summary

This is an open-label, multicenter, dose confirmation, and PK study of JZP-458 in patients (of any age) with ALL/LBL who are hypersensitive to E. coli-derived asparaginases (allergic reaction or silent inactivation). This study is designed to assess the tolerability and efficacy of JZP-458 (only in patients who develop hypersensitivity to an E. coli-derived asparaginase), as measured by asparaginase activity.

Details
Treatment IM JZP-458, IV JZP-458
Clinical Study IdentifierNCT04145531
SponsorJazz Pharmaceuticals
Last Modified on25 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Male or Female
Do you have any of these conditions: childhood ALL or Lymphocytic Leukemia, Acute or Lymphoid leukemia?
Do you have any of these conditions: acute lymphoblastic leukemia (all) or Lymphoid leukemia or Lymphocytic Leukemia, Acute or acute lymphoblastic leukemia or acute lymphoid leukaemia or ...?
Do you have any of these conditions: acute lymphocytic leukemia or lymphatic leukaemia or childhood ALL or lymphocytic leukemia or acute lymphoblastic leukemia (all) or lymphoblastic leuk...?
Pediatric and adult patients with a diagnosis of ALL or LBL
Have had an allergic reaction to a long-acting E. coli-derived asparaginase OR have silent inactivation
Have 1 or more courses of E. coli-derived asparaginase remaining in his/her treatment plan
Patients must have, in the opinion of the Investigator, fully recovered from their prior allergic reaction to E. coli-derived asparaginase

Exclusion Criteria

Have previously received asparaginase Erwinia chrysanthemi or JZP-458
Have relapsed ALL or LBL
Are concurrently receiving another investigational agent and/or treated with an investigational device at the same time as JZP-458 (within 48 hours) during Course 1 of JZP-458
Have a history of Grade 3 pancreatitis
Prior history of asparaginase-associated Grade 3 hemorrhagic event or asparaginase-associated thrombus requiring anticoagulation therapy, excluding catheter-related thrombotic events
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