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NCT02257684
A Dose Confirmation and Pharmacokinetic Study of Pegcrisantaspase Administered as Intravenous (IV) Infusion in Children and Young Adults With Acute Lymphoblastic Leukemia (ALL) /Lymphoblastic Lymphoma (LBL). Following Hypersensitivity to Pegaspargase (Oncaspar)
Phase 2 trial testing pegcrisantaspase in Acute Lymphoblastic Leukemia in 4 participants. Terminated before completion.
1 February 2015
Quick facts
| Lead sponsor | Jazz Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 4 |
| Start date | 1 September 2014 |
| Primary completion | 1 February 2015 |
| Estimated completion | 1 January 2016 |
| Sites | 43 locations across United States |
Drugs / interventions tested
- pegcrisantaspase — full drug profile →
Conditions studied
- Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
- Lymphoblastic Lymphoma — all drugs for Lymphoblastic Lymphoma →
Sponsor
Jazz Pharmaceuticals — full company profile →
Who can join
Adults 1 to 21, any sex, with Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The Response Rate in Children & Young Adults With ALL/LBL and Hypersensitivity to Pegaspargase Defined as the Proportion of Subjects Having a Serum Asparaginase Activity (SAA) Level of >= 0.1 IU/mL Following the First IV Dose in Course 1
Time frame: 15 days during Course 1 -
The Serum Asparaginase Activity 14 Days After the First Infusion of Study Drug and the Adverse Events in All Participants.
Time frame: 1 Year
Sponsor's own description
The purpose of this study is to evaluate the effectiveness,safety, and dosage of pegcrisantaspase in patients with Acute Lymphoblastic Leukemia (ALL) / Lymphoblastic Lymphoma (LBL).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Anti-PEG antibodies in the clinic: Current issues and beyond PEGylation.
Zhang P, Sun F, Liu S, Jiang S. · · 2016 · cited 459× · PMID 27369864 · DOI 10.1016/j.jconrel.2016.06.040
Verify or expand the search:
- PubMed search for NCT02257684
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Jazz Pharmaceuticals trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02257684 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jazz Pharmaceuticals
- Last refreshed: 6 March 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02257684.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing