Actively Recruiting
CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-03-06
7
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
S
Servier
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of the study is to evaluate the safety and tolerability of the study drug, calaspargase pegol, when given with multi-agent chemotherapy.
CONDITIONS
Official Title
CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed Philadelphia negative B- or T-cell acute lymphoblastic leukemia with >10% peripheral blood or bone marrow lymphoblasts at diagnosis
- Completed treatment and fully recovered from arm 1A of the Hyper-CVAD regimen
- Willing and able to provide written informed consent or assent for the trial
- Able to comply with study visit schedule and protocol requirements
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Cardiac ejection fraction ≥ 50% by echocardiography or MUGA measured before arm 1A of Hyper-CVAD
- Serum bilirubin and creatinine less than 1.5 times upper limit of normal (ULN); AST and ALT less than 3 times ULN
- Females of childbearing potential must have a negative serum pregnancy test at screening
- Females of childbearing potential must use two highly effective non-hormonal contraceptive methods, be surgically sterile, or abstain from heterosexual activity during the study and for 3 months after the last treatment dose
- Male subjects must use adequate contraception starting with first dose through 30 days after last dose and agree not to donate sperm during and for 3 months after the study
You will not qualify if you...
- Received induction therapy with any regimen other than Hyper-CVAD 1A
- Diagnosis of L3 type Burkitt's lymphoma
- Clinical evidence of active central nervous system leukemia
- Major surgery or radiation therapy within 4 weeks
- Diagnosis of Down Syndrome
- Active infection requiring systemic therapy including HIV, Hepatitis B, or Hepatitis C
- History or current condition that could interfere with trial participation or outcomes, including unstable angina, pre-existing liver disease, recurrent pancreatitis, uncontrolled diabetes, hypertriglyceridemia, pulmonary hypertension, or severe heart failure (NYHA Class III-IV)
- Recurrent thrombosis or non-central venous catheter associated thrombosis within 3 months before enrollment
- Severe comorbid conditions with life expectancy less than 6 months
- Active uncontrolled or metastatic second malignancies
- Pregnant, breastfeeding, or expecting to conceive or father children during the study and for 3 months after the last treatment dose
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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