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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with L3 type Burkitt's lymphoma.I have active leukemia in my brain or spinal cord.I am fully active or can carry out light work.I received initial cancer treatment that was not Hyper-CVAD 1A.I agree to follow strict birth control measures or abstain from sex during and 3 months after the study.I haven't had major surgery or radiation therapy in the last 4 weeks.I do not have any infections needing treatment through the bloodstream.I agree to use contraception and not donate sperm during the study and for 3 months after.My life expectancy is more than 6 months despite my severe health conditions.I have had a blood clot not related to a central venous catheter in the last 3 months.I have completed and fully recovered from the first part of the Hyper-CVAD treatment.I am a woman who can have children and have a negative pregnancy test.My leukemia is not Philadelphia chromosome positive and was confirmed with more than 10% cancer cells in my blood or bone marrow.I don't have any health issues that could affect my trial participation or results.I do not have any other spreading cancers that are not under control.My heart pumps well, with an ejection fraction of 50% or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Hyper-CVAD + Calaspargase pegol Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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