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PEG-Asparaginase

Phase 1

Acute Lymphoblastic Leukemia | Small molecule | Oncology |Novartis AG|Last Updated: Jul 18, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

PEG-Asparaginase · 1 trial · 1 indication

Phase 1 1
NCT01523977Everolimus With Multiagent Re-Induction Chemotherapy in Pediatric Patients With ALLAcute Lymphoblastic Leukemia
COMPLETED22 Analytics
PHASE1COMPLETED
Everolimus With Multiagent Re-Induction Chemotherapy in Pediatric Patients With ALL
Acute Lymphoblastic LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Feasibility
2 years

To determine the safety and feasibility of treatment with everolimus in combination with vincristine, prednisone, PEG-asparaginase and doxorubicin in patients with relapsed acute lymphoblastic leukemia (ALL)

Secondary Endpoints

Clinical Activity
2 years
Impact on biologic markers
2 years
Determinants of Response
2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
EverolimusDRUGOrally, daily days 1-32 per assigned dose level
PrednisoneDRUG40 mg/m2/day orally 3 x daily days 4-32
VincristineDRUG1.5 mg/m2 IV daily on days 4, 11, 18, and 25
PEG-AsparaginaseDRUG2,500 U/m2 IV 1 x daily on days 5 and 18
DoxorubicinDRUG30 mg/m2 IV on days 4 and 5
DexrazoxaneDRUG300 mg/m2 IV on days 4 and 5
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Eligibility Criteria

Age Range18 Months to 21 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * ALL in first bone marrow relapse occuring \> 18 months from initial diagnosis * Normal organ function * Maximum prior cumulative doxorubicin dose of \</= 360 mg/m2 or equivalent Exclusion Criteria: * Prior therapy for ALL except for intrathecal (IT) chemotherapy * Pregnant o...

Countries:United States
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Frequently asked questions about PEG-Asparaginase

What is PEG-Asparaginase used for in Acute Lymphoblastic Leukemia?

PEG-Asparaginase is used for the treatment of Acute Lymphoblastic Leukemia (ALL). It is being studied as part of a multiagent re-induction chemotherapy regimen in pediatric patients with ALL. The drug is currently in Phase 1 clinical development and is considered investigational.

Who makes PEG-Asparaginase?

PEG-Asparaginase is developed by Novartis AG, which is publicly traded under the ticker symbol NVS. The company is conducting clinical research on this drug for the treatment of Acute Lymphoblastic Leukemia.

What phase is PEG-Asparaginase in?

PEG-Asparaginase is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, with no active trials currently ongoing.

What clinical trials is PEG-Asparaginase in?

PEG-Asparaginase has been studied in one completed clinical trial, identified as NCT01523977. This Phase 1 trial, titled 'Everolimus With Multiagent Re-Induction Chemotherapy in Pediatric Patients With ALL,' enrolled 22 participants in the United States.

How does PEG-Asparaginase work?

PEG-Asparaginase is a small molecule drug. It is being investigated for its role in treating Acute Lymphoblastic Leukemia, though its specific molecular target has not been disclosed in available information.