Clinical trial · Interventional
1336GCC: Study of Erwinaze for Treatment of Acute Myeloid Leukemia (AML)
1336GCC: Open-Label, Single-Arm PK Study of IV Erwinaze (Asparaginase Erwinia Chrysanthemi) to Find the Dose With Acceptable Therapeutic and Safety Profile in Adults With Acute Myeloid Leukemia With or Without Isocitrate Dehydrogenase Mutations
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Erwinaze will be administered intravenously at a dose of 25,000 IU/m2 (dose cohort 0) for 6 doses MWF over a period of 2 weeks to 9 patients (as described below and in the following schema). Blood counts, chemistries including bilirubin, amylase and lipase, and coagulation studies including fibrinogen will be measured and reviewed before each asparaginase dose. Fibrinogen (\<100 mg/dL) can be replaced with cryoprecipitate before each dose at the discretion of treating physician. Treatment will be stopped for elevation of amylase, lipase or direct bilirubin above normal range.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erwinase | Drug | Asparaginase | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ewwinase
- description
- Six doses of Erwinase given three times weekly (Monday-Wednesday-Friday) for two weeks. Possible dose levels used are 20.000 IU/m2/day, 25,000IU/m2/day, and 30,000IU/m2/day.
- interventionNames
- Drug: Erwinase
Primary outcomes (6)
- measure
- To determine the dose of Erwinase that produces a plasma glutamine level ≤120 μmol/L with an acceptable safety profile.
- timeFrame
- Day 3
- description
- The dose of Erwinase that produces a plasma glutamine level ≤120 µmol/L with an acceptable safety profile.
- measure
- Efficacy of Erwinase doses as measured by plasma glutamine level
- timeFrame
- Day 5
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed AML * 18 years and older * AML has relapsed after, or is refractory to, first-line therapy, with or without subsequent additional therapy * Have received or are ineligible for immediate established curative regimens * ASCT patients are eligible provided that they are \>= 4 weeks from stem cell infusion * alloSCT patients are eligible if they are \>= 60 days post stem cell infusion, have no evidence of graft versus host disease (GVHD) \> Grade 1, and are \>= 2 weeks off all immunosuppressive therapy * Previous cytotoxic chemotherapy completed at least 3 weeks and radiotherapy at least 2 weeks prior to day 1 of study treatment * Biologic agents stopped at least 1 week prior to day 1 of study treatment * DNA methyltransferase inhibitors stopped at least 3 weeks prior to day 1 of study treatment * ECOG performance status ≤2 * Patients must have normal organ function * Female patients of childbearing potential must have a negative pregnancy test. * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * Patients receiving any other investigational agents, or concurrent chemotherapy, radiation therapy, or immunotherapy * Patients with acute promyelocytic leukemia * Patients with active central nervous system leukemia * Prior treatment with Erwinaze * Hyperleukocytosis with \> 50,000 blasts/μL * History of a major thrombotic event * History of pancreatitis * Active, uncontrolled infection * Uncontrolled intercurrent illness * Pregnant women * Uncontrolled active seizure disorder or a history of seizure
References
Publications (0)
Data not yet available