OncoMatch/Clinical Trials/NCT05581030
CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
Is NCT05581030 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Hyper CVAD Protocol (Standard of Care Multi-Agent Chemotherapy) and Calaspargase Pegol for acute lymphoblastic leukemia.
Treatment: Hyper CVAD Protocol (Standard of Care Multi-Agent Chemotherapy) · Calaspargase Pegol · Rituximab — The purpose of the study is to evaluate the safety and tolerability of the study drug, calaspargase pegol, when given with multi-agent chemotherapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: BCR wild-type
Philadelphia negative
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: Hyper-CVAD regimen (arm 1A) — induction
Treatment and full recovery from arm 1A of the Hyper-CVAD regimen
Cannot have received: any regimen other than Hyper-CVAD 1A
Induction therapy with any regimen other than Hyper-CVAD 1A
Lab requirements
Kidney function
Serum creatinine < 1.5x ULN
Liver function
Serum bilirubin < 1.5x ULN; AST and ALT < 3x ULN
Cardiac function
Ejection fraction ≥ 50% by echocardiography or MUGA, as measured prior to arm 1A of Hyper-CVAD
Cardiac ejection fraction ≥ 50% by echocardiography or MUGA, as measured prior to arm 1A of Hyper-CVAD. Serum bilirubin and creatinine < 1.5x upper limit of normal (ULN). AST and ALT must be <3x ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
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