Status:
COMPLETED
1336GCC: Study of Erwinaze for Treatment of Acute Myeloid Leukemia (AML)
Lead Sponsor:
Ashkan Emadi
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 cou...
Detailed Description
For safety: Erwinaze has been already used in clinical practice for treatment of patients with acute leukemia with known side effect profile. For this reason, in this protocol, we use the "3+3+3" des...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT02283190
Start Date
April 1 2014
End Date
September 1 2017
Last Update
March 12 2018
Active Locations (1)
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1
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201