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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mortality Rate of Hyper-CVAD after first infusion of calaspargase pegol
Secondary outcome measures
Minimal Residual Disease Remission Rate
Overall Survival
Progression Free Survival
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
~1880
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,472 Total Patients Enrolled
ServierIndustry Sponsor
49 Previous Clinical Trials
43,436 Total Patients Enrolled
Bijal Shah, MDPrincipal InvestigatorMoffitt Cancer Center
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor still open for enrollment?
"Indeed, up-to-date information from clinicaltrials.gov confirms that this trial is actively recruiting applicants. This study was initially posted on September 16th 2022 and the latest update occured October 12th of the same year. The experiment requires 20 volunteers at a single location to be successful."
Answered by AI
What criteria must I fulfill to become a participant in this research endeavor?
"Only persons with acute lymphoblastic leukemia (ALL) who are between 18 and 50 years old may be eligible for this clinical trial. The study aims to recruit a total of 20 individuals."
Answered by AI
How many individuals have registered to participate in this experiment?
"Affirmative. According to clinicaltrials.gov, this experiment was first advertised on September 16th 2022 and has since been edited as recently as October 12th 2022. The study is aiming to recruit 20 participants from a single location."
Answered by AI
Has Hyper-CVAD + Calaspargase pegol Treatment been granted approval by the FDA?
"Data suggests that Hyper-CVAD + Calaspargase pegol Treatment carries a moderate risk, our team at Power gave it an assessment of 1 on the safety scale. This is because Phase 1 trials typically have limited clinical data to support both efficacy and safety."
Answered by AI
Does this investigation include persons aged 25 or over?
"As outlined in the selection criteria, only people aged 18 to 50 can join this clinical trial."
Answered by AI
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