OncoMatch/Clinical Trials/NCT05581030
CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
Is NCT05581030 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: BCR wild-type
Philadelphia negative
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05581030 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior any regimen other than Hyper-CVAD 1A disqualifies patients from enrollment.
Does this trial require BCR?
Yes, BCR wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 50 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages