Status:
WITHDRAWN
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well arsenic trioxide works in treating patients with relapsed or refractory acute myeloid leukemia. Drugs used in chemotherapy, such as arsenic trioxide, work in diffe...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the complete remission rate of relapsed and refractory acute myeloid leukemia (AML) patients with Mutated Nucleophosmin 1 (NPM1) gene. SECONDARY OBJECTIVES: I. Dete...
Eligibility Criteria
Inclusion
- AML, any French- American- British (FAB) subtype except M3, with confirmed mutation in the NPM1 gene
- Relapsed and/or refractory AML from any duration of complete remission (CR); any number of prior therapies allowed
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2, life expectancy \> 3 months
- Serum creatinine =\< 2.0 mg/dL
- Bilirubin =\< 2.0 mg/dL
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =\< 3 x upper limit of normal (ULN)
- Ability to understand and the willingness to sign a written informed consent document
Exclusion
- Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies; pregnancy tests must be obtained in women; sexually active males or females may not participate unless they have agreed to use an effective contraceptive method
- Patients who are currently receiving another investigational drug
- Patients who are currently receiving other anti-cancer agents
- Uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
- Known hypersensitivity to arsenic trioxide
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01835288
Start Date
May 1 2013
Last Update
May 21 2018
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