Characterizing the regimen limiting toxicity (RLT) of chemotherapeutic drug Calaspargase Pegol-mknl as remission induction and consolidation chemotherapy in patients with newly diagnosed Acute Myeloid Leukemia (AML) and Identifying the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Calaspargase Pegol-mknl.
This is a single center, non-randomized, open-label, phase I study evaluating regimen-limiting toxicities of Calaspargase Pegol-mknl administered intravenously in Adult Patients with Newly Diagnosed Acute Myeloid Leukemia (AML). The trial will consist of the induction and consolidation phases of therapy. At the induction phase ( it usually lasts for 29 days): a high-dose of Cytarabine will be administered IV for six doses, plus Idarubicin administered IV for three doses and Calaspargase Pegol-mknl administered IV one dose, using a dose-escalation scheme. At the consolidation phase (single cycle of consolidation lasts 4-8 weeks): a high-dose of Cytarabine will be administered IV for six doses, and Calaspargase Pegol-mknl administered IV for one dose, using a dose-escalation scheme. The FDA (The US Food and Drug Administration) has not approved Calaspargase Pegol-mknl for Adult Patients with Newly Diagnosed Acute Myeloid Leukemia (AML).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Calaspargase pegol-mknl
Greenebaum Cancer Center, University of Maryland Medical Systems
Baltimore, Maryland, United States
West Virginia University
Morgantown, West Virginia, United States
Primary Outcome Measure
1\. Incidence of regimen limiting toxicities (RLTs) and Incidence of treatment-emergent adverse events (TEAE).
Time frame: From the first day of treatment until 30 days after receiving Calaspargase Pegol-mknl
1. CR+CRh+CRi
Complete remission (CR) + complete remission with partial hematologic recovery (CRh) + complete remission with incomplete count recovery (CRi)
Time frame: Within 4-8 weeks following completion of induction regimen and completion of consolidation therapy
2. The duration of CR/CRh/CRi.
The duration of Complete remission (CR) / complete remission with partial hematologic recovery (CRh) / complete remission with incomplete count recovery (CRi)
Time frame: immediately after the intervention
3. Achievement of MRD <0.02% at the end of Induction therapy with Calaspargase pegol-mknl.
Achievement of MRD \<0.02% at the end of Induction therapy with Calaspargase pegol-mknl.
Time frame: During the intervention
4. Event-free survival (EFS).
Event-free survival (EFS).
Time frame: 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
5. Overall survival (OS)
Overall survival (OS)
Time frame: 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
6. Proceeding to allo-HSCT after Calaspargase pegol-mknl treatment
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Proceeding to allo-HSCT after Calaspargase pegol-mknl treatment
Time frame: Immediately after the intervention
7. Plasma asparagine and glutamine and other amino acids levels at baseline and weekly after administration of Calaspargase pegol-mknl. for four weeks.
Plasma asparagine and glutamine and other amino acids levels at baseline and weekly after administration of Calaspargase pegol-mknl. for four weeks.
Time frame: 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
Plasma asparaginase activity at baseline and weekly after administration of Calaspargase pegol-mknl for four weeks
Time frame: At baseline and weekly after administration of Calaspargase pegol-mknl for four weeks