Can an enzyme blocker boost leukemia chemotherapy?
NCT ID NCT04953780
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
This phase 1 trial tests whether adding the experimental drug calaspargase pegol-mknl to standard chemotherapy can safely help adults with newly diagnosed acute myeloid leukemia (AML). Researchers aim to find the highest tolerable dose and watch for side effects. They will also track how many patients achieve complete remission. The study enrolls adults aged 18 to 65 with confirmed AML.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- calaspargase pegol-mknl, an experimental drug added to standard chemotherapy (high-dose cytarabine and idarubicin)
- What this could lead to
- If it works, this combination could improve remission rates for adults with newly diagnosed acute myeloid leukemia, potentially leading to a more effective first-line treatment.
- What could go wrong
- This is a small, early-phase trial focused on safety and dosing. The drug may cause serious side effects, and it is too soon to know if it will improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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6 people
The number who actually took part.
- Started
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Sep 2021
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * A histologically or pathologically confirmed diagnosis of AML based on WHO classification. Patients with myelodysplastic syndromes (MDS) or myeloproliferative neoplasms (MPN) evolving into AML who are candidates for AML induction therapy are eligible for enrollment. * Age 18-65 years old. * ECOG performance status \< 3. * Patients must have normal organ function as defined below: * Total bilirubin ≤2X the institutional upper limit of normal (ULN) (except in patients with leukemic infiltration of the liver) * AST(SGOT)/ALT(SGPT) ≤3X ULN (except if attributable to leukemic infiltration of the liver) * Creatinine Clearance (CrCl) ≥ 40 mL/min (except in patients with evidence of tumor lysis syndrome) * Left ventricular ejection fraction (LVEF) ≥50% * Female patients of childbearing potential must have a negative pregnancy test \<1 week before enrollment. Female patients of childbearing potential who are sexually active and male patients who are sexually active and have female partners of childbearing potential must agree to use a highly effective method of non-hormonal contraception. Contraception should be used during treatment and for at least 3 months after the last dose of Calaspargase pegol-mknl. * Ability to understand and willingness to sign a written informed consent document. * Agree to comply with the study requirements and agrees to come to the clinic/hospital for required study visits Exclusion Criteria: * Patients with the following clinical histories are excluded: * severe pancreatitis not related to cholelithiasis. Severe acute pancreatitis as defined by lipase elevation \>5X ULN and with signs or symptoms * unprovoked DVT * PE * serious or life-threatening thrombosis in any location of the body * hemorrhagic or thromboembolic stroke * major hemorrhagic event within three weeks before signing ICF; hemorrhage due to thrombocytopenia from underlying AML is excluded * patients with hemorrhagic diathesis * neurologic/cerebellar disorders that may confound the toxicity monitoring of HiDAC * history of serious hypersensitivity reactions to pegylated L-asparaginase therapy * Patients receiving any other investigational agents or concurrent chemotherapy or immunotherapy. Hydroxyurea for blast count control is permitted before starting treatment and up to a maximum of 10 days after starting treatment on the study. * Patients with AML with any of the following cytogenetic abnormalities: t(15;17), t(8;21), inv(16), t(16;16). * Pregnant women and female patients who are lactating and do not agree to stop breast-feeding. * Uncontrolled undercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled active seizure disorder, or psychiatric illness/social situations that per site Principal Investigator's judgment would limit compliance with study requirements
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Greenebaum Cancer Center, University of Maryland Medical Systems
Baltimore, Maryland, 21201, United States
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West Virginia University
Morgantown, West Virginia, 26506, United States
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Other studies related to the condition(s) this trial covers.
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