Calaspargase pegol-mknl for Acute Myeloid Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acute Myeloid LeukemiaCalaspargase pegol-mknl - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Acute Myeloid Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: 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

After the enrollment of the study subjects
Exploratory Endpoint 1
Exploratory Endpoint 2
Exploratory Endpoint 3
Exploratory Endpoint 4
At baseline and weekly after administration of Calaspargase pegol-mknl for four weeks
7. Plasma asparagine and glutamine and other amino acids levels at baseline and weekly after administration of Calaspargase pegol-mknl. for four weeks.
8.Plasma asparaginase activity at baseline and weekly after administration of Calaspargase pegol-mknl for four weeks
During the intervention
3. Achievement of MRD <0.02% at the end of Induction therapy with Calaspargase pegol-mknl.
Month 100
4. Event-free survival (EFS).
5. Overall survival (OS)
Day 30
Measure
Immediately after the intervention
6. Proceeding to allo-HSCT after Calaspargase pegol-mknl treatment
Week 8
1. CR+CRh+CRi
immediately after the intervention
2. The duration of CR/CRh/CRi.

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Calaspargase pegol-mknl dose level 4
1 of 4
Calaspargase pegol-mknl dose level 1
1 of 4
Calaspargase pegol-mknl dose level 3
1 of 4
Calaspargase pegol-mknl dose level 2
1 of 4

Experimental Treatment

24 Total Participants · 4 Treatment Groups

Primary Treatment: Calaspargase pegol-mknl · No Placebo Group · Phase 1

Calaspargase pegol-mknl dose level 4
Drug
Experimental Group · 1 Intervention: Calaspargase pegol-mknl · Intervention Types: Drug
Calaspargase pegol-mknl dose level 1
Drug
Experimental Group · 1 Intervention: Calaspargase pegol-mknl · Intervention Types: Drug
Calaspargase pegol-mknl dose level 3
Drug
Experimental Group · 1 Intervention: Calaspargase pegol-mknl · Intervention Types: Drug
Calaspargase pegol-mknl dose level 2
Drug
Experimental Group · 1 Intervention: Calaspargase pegol-mknl · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
610 Previous Clinical Trials
333,781 Total Patients Enrolled
Ashkan Emadi, M.D.,Ph.D.Principal InvestigatorUniversity of Maryland, Baltimore
1 Previous Clinical Trials
30 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a histologically or pathologically confirmed diagnosis of AML based on WHO classification.
You are able to understand and are willing to sign a written informed consent document.
Total bilirubin ≤2x the institutional ULN.
AST/ALT ratio is greater than 3x ULN.
Creatinine Clearance (CrCl) ≥ 40 mL/min.
You agree to come to the clinic/hospital for required study visits.
You have a left ventricular ejection fraction (LVEF) of 50% or more.
References