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Enzyme
Chemotherapy for Acute Myeloid Leukemia
Phase 1
Waitlist Available
Led By Vu Duong, MD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18-65 years old
ECOG performance status < 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first date of intervention until the first documented progression or the date of death from any causes, whichever came first, assessed up to 100 months
Awards & highlights
Study Summary
This trial is testing a new chemotherapy drug to treat AML. They are trying to find the best dose of the drug to minimize side effects while still being effective.
Who is the study for?
This trial is for adults aged 18-65 with newly diagnosed AML who can attend required visits, have normal organ function, and agree to use non-hormonal contraception. Excluded are those with severe pancreatitis unrelated to gallstones, unprovoked blood clots or strokes, major bleeding events recently, hypersensitivity to similar drugs, other treatments for cancer ongoing or certain genetic abnormalities in their leukemia.Check my eligibility
What is being tested?
The study tests Calaspargase Pegol-mknl as a chemotherapy agent for AML patients. It aims to find the highest dose patients can take without serious side effects (MTD) and decide on a recommended dose for future Phase 2 trials (RP2D).See study design
What are the potential side effects?
Potential side effects of Calaspargase Pegol-mknl may include allergic reactions due to its pegylated nature, liver dysfunction indicated by elevated bilirubin levels, abnormal blood clotting leading to thrombosis or stroke risks, and possible impact on heart function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
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I can take care of myself but may not be able to do heavy physical work.
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My diagnosis of AML is confirmed by lab tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the first date of intervention until the first documented progression or the date of death from any causes, whichever came first, assessed up to 100 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the first date of intervention until the first documented progression or the date of death from any causes, whichever came first, assessed up to 100 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measure
Secondary outcome measures
1. CR+CRh+CRi
2. The duration of CR/CRh/CRi.
3. Achievement of MRD <0.02% at the end of Induction therapy with Calaspargase pegol-mknl.
+5 moreOther outcome measures
Exploratory Endpoint 1
Exploratory Endpoint 2
Exploratory Endpoint 3
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Calaspargase pegol-mknl dose level 4Experimental Treatment1 Intervention
Induction Phase (It usually lasts 29 days):
The subject will take Cytarabine 3000 mg/m2 in an IV every 12 hours on days 1, 3, 5 for 6 doses.
The subject will take Idarubicin 12 mg/m2 for three doses in an IV after the first, third, and fifth High-dose Cytarabine.
The subject will take a dose of 2,000 U/m2 of Calaspargase pegol-mknl in an IV after the last (6th) dose of High-dose Cytarabine every 21 days ( per cycle).
Consolidation Phase ( One cycle of consolidation lasts 4-8 weeks):
The subject will take Cytarabine 3000 mg/m2 in an IV every 12 hours on days 1, 3, 5 for 6 doses.
The subject will take a dose of 2,000 U/m2 of Calaspargase pegol-mknl in an IV after the last (6th) dose of High-dose Cytarabine per cycle.
A single cycle of consolidation may last between 4-8 weeks in duration.
Group II: Calaspargase pegol-mknl dose level 3Experimental Treatment1 Intervention
Induction Phase (It usually lasts 29 days):
The subject will take Cytarabine 3000 mg/m2 in an IV every 12 hours on days 1, 3, 5 for 6 doses.
The subject will take Idarubicin 12 mg/m2 for three doses in an IV after the first, third, and fifth High- dose Cytarabine.
The subject will take a dose of 1,500 U/m2 of Calaspargase pegol-mknl in an IV after the last (6th) dose of High-dose Cytarabine every 21 days ( per cycle).
Consolidation Phase ( One cycle of consolidation lasts 4-8 weeks):
The subject will take Cytarabine 3000 mg/m2 in an IV every 12 hours on days 1, 3, 5 for 6 doses.
The subject will take a dose of 1,500 U/m2 of Calaspargase pegol-mknl in an IV after the last (6th) dose of High-dose Cytarabine.
A single cycle of consolidation may last between 4-8 weeks in duration.
Group III: Calaspargase pegol-mknl dose level 2Experimental Treatment1 Intervention
Induction Phase (It usually lasts 29 days):
The subject will take Cytarabine 3000 mg/m2 in an IV every 12 hours on days 1, 3, 5 for 6 doses.
The subject will take Idarubicin 12 mg/m2 for three doses in an IV after the first, third, and fifth High-dose Cytarabine.
The subject will take a dose of 1,000 U/m2 of Calaspargase pegol-mknl in an IV after the last (6th) dose of High-dose Cytarabine every 21 days ( per cycle).
Consolidation Phase ( One cycle of consolidation lasts 4-8 weeks):
The subject will take Cytarabine 3000 mg/m2 in an IV every 12 hours on days 1, 3, 5 for 6 doses.
The subject will take a dose of 1,000 U/m2 of Calaspargase pegol-mknl in an IV after the last (6th) dose of High-dose Cytarabine(every 21 days ( per cycle).
A single cycle of consolidation may last between 4-8 weeks in duration.
Group IV: Calaspargase pegol-mknl dose level 1Experimental Treatment1 Intervention
Induction Phase (It usually lasts 29 days):
The subject will take Cytarabine 3000 mg/m2 in an IV every 12 hours on days 1, 3, 5 for 6 doses.
The subject will take Idarubicin 12 mg/m2 for three doses in an IV after the first, third, and fifth High-dose Cytarabine.
The subject will take a dose of 750 U/m2 of Calaspargase pegol-mknl in an IV after the last (6th) dose of High-dose Cytarabine every 21 days ( per cycle).
Consolidation Phase ( One cycle of consolidation lasts 4-8 weeks):
The subject will take Cytarabine 3000 mg/m2 in an IV every 12 hours on days 1, 3, 5 for 6 doses.
The subject will take a dose of 750 U/m2 of Calaspargase pegol-mknl in an IV after the last (6th) dose of High-dose Cytarabine.
A single cycle of consolidation may last between 4-8 weeks in duration.
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,650 Total Patients Enrolled
Vu Duong, MDPrincipal InvestigatorUniversity of Maryland, Baltimore
2 Previous Clinical Trials
29 Total Patients Enrolled
Ashkan Emadi, M.D.,Ph.D.Principal InvestigatorUniversity of Maryland, Baltimore
1 Previous Clinical Trials
27 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding, or I agree to stop breastfeeding if I am.I have had a blood clot in my leg that occurred without any clear reason.I am between 18 and 65 years old.I am not pregnant and agree to use effective birth control during the study.I do not have any brain disorders that could affect my treatment's side effect monitoring.I am not currently on any experimental drugs or receiving chemotherapy or immunotherapy.I have had a stroke caused by bleeding or blood clots.I have had a serious blood clot.I have bleeding issues due to low platelet counts from my AML.My condition has progressed from MDS or MPN to AML, and I am a candidate for AML induction therapy.I have a bleeding disorder.I can take care of myself but may not be able to do heavy physical work.My diagnosis of AML is confirmed by lab tests.I have had severe pancreatitis not caused by gallstones.My AML has specific genetic changes.I agree to follow the study rules and attend all required visits.
Research Study Groups:
This trial has the following groups:- Group 1: Calaspargase pegol-mknl dose level 2
- Group 2: Calaspargase pegol-mknl dose level 4
- Group 3: Calaspargase pegol-mknl dose level 1
- Group 4: Calaspargase pegol-mknl dose level 3
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.
What is the total participant count for this clinical research endeavor?
"Affirmative. Clinicaltrials.gov reveals that this clinical trial, initially posted on September 27th 2021 is presently recruiting patients. To complete the study, 24 individuals need to be recruited from one centre."
Answered by AI
What are the security considerations for utilizing Calaspargase pegol-mknl?
"As this is a preliminary Phase 1 trial, there is minimal data supporting the safety and effectiveness of Calaspargase pegol-mknl. Hence our team at Power assign it a score of 1 on the scale from one to three."
Answered by AI
What prior investigations have occurred involving the usage of Calaspargase pegol-mknl?
"Presently, 6 distinct clinical trials are being conducted on Calaspargase pegol-mknl. Two of the active studies have reached Stage 3. Although most tests take place in Portland, Oregon, a total of 240 sites across America offer this medication to patients."
Answered by AI
Does this medical research still have room for participants?
"Affirmative. Clinicaltrials.gov confirms that this research trial was posted on September 27th 2021 and is currently searching for participants, with 24 individuals required at a single medical centre."
Answered by AI
To whom is this clinical trial open for participation?
"This medical trial seeks to enrol 24 individuals of ages 18-65 who have been diagnosed with myeloid leukemia. Furthermore, these patients must meet a number of additional criteria that include having an ECOG performance status < 3, total bilirubin ≤2X the institutional upper limit of normal (ULN), AST(SGOT)/ALT(SGPT) ≤3X ULN, CrCl ≥ 40 mL/min; additionally female and male participants between childbearing age must agree to use birth control during treatment plus three months after the last dose is taken. Additionally all potential participants need to have LVEF ≥50%."
Answered by AI
Does this medical trial accept participants of a minimum age of 20?
"This medical trial is only open to adults between 18 and 65 years of age. However, there are an additional 453 trials for minors and 1,234 studies specifically targeting seniors."
Answered by AI
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