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Enzyme

CalPeg + Chemotherapy for Acute Lymphoblastic Leukemia

Phase 1
Recruiting
Led By Bijal Shah, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new drug, given with chemotherapy, to see if it's safe and well-tolerated.

Who is the study for?
This trial is for adults with newly diagnosed acute lymphoblastic leukemia (ALL) who are in good physical condition (ECOG 0-1), have a functioning heart, liver, and kidneys, and can follow the study schedule. Women must use effective non-hormonal birth control or abstain from sex; men also need to use contraception. Excluded are those with other cancers, certain infections like HIV/Hepatitis B/C, recent major surgery or radiation therapy, CNS leukemia symptoms, severe health conditions affecting participation safety.
What is being tested?
The trial tests calaspargase pegol's safety when combined with Hyper CVAD chemotherapy and rituximab in treating ALL. Participants will receive this combination treatment to see how well they tolerate it compared to standard treatments alone.
What are the potential side effects?
Potential side effects include reactions related to the immune system such as allergies or inflammation of organs due to calaspargase pegol; nausea, hair loss, fatigue from chemotherapy; and possible infusion-related reactions from rituximab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mortality Rate of Hyper-CVAD after first infusion of calaspargase pegol
Secondary study objectives
Minimal Residual Disease Remission Rate
Overall Survival
Progression Free Survival

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hyper-CVAD + Calaspargase pegol TreatmentExperimental Treatment3 Interventions
Participants will receive calaspargase pegol administered over 1 hour with each cycle of Hyper-CVAD, mini-CVD, and late intensification, beginning with Cycle 1B. Responding patients will have dose reduction of HyperCVAD for Cycles 2B-4B. Participants with CD20+ ALL will also be given Rituximab once per cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~2990

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
561 Previous Clinical Trials
144,809 Total Patients Enrolled
ServierIndustry Sponsor
50 Previous Clinical Trials
44,239 Total Patients Enrolled
Bijal Shah, MDPrincipal InvestigatorMoffitt Cancer Center

Media Library

Calaspargase Pegol (Enzyme) Clinical Trial Eligibility Overview. Trial Name: NCT05581030 — Phase 1
Acute Lymphoblastic Leukemia Research Study Groups: Hyper-CVAD + Calaspargase pegol Treatment
Acute Lymphoblastic Leukemia Clinical Trial 2023: Calaspargase Pegol Highlights & Side Effects. Trial Name: NCT05581030 — Phase 1
Calaspargase Pegol (Enzyme) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05581030 — Phase 1
~4 spots leftby May 2025