Phase 2
N=27
Choline Magnesium Trisalicylate and Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia
Adult Acute Megakaryoblastic Leukemia (M7) · Adult Acute Minimally Differentiated Myeloid Leukemia (M0) · Adult Acute Monoblastic Leukemia (M5a) · Adult Acute Monocytic Leukemia (M5b) · Adult Acute Myeloblastic Leukemia With Maturation (M2)
Bottom Line
View on ClinicalTrials.gov: NCT02144675 ↗Enrolled (actual)
27
Serious AEs
3.7%
Results posted
Jul 2018
Primary outcome: Primary: Inhibition of NF-kB Target Transcripts and/or Inhibition of Drug Efflux in at Least 50% of Patients — 13; 14 Participants — p=<.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- choline magnesium trisalicylate (Drug); idarubicin (Drug); cytarabine (Drug); laboratory biomarker analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inhibition of NF-kB Target Transcripts and/or Inhibition of Drug Efflux in at Least 50% of Patients |
13; 14 | <.05 sig |
Summary
This randomized phase II trial studies how well choline magnesium trisalicylate with idarubicin and cytarabine works in treating patients with acute myeloid leukemia. Drugs used in chemotherapy, such as choline magnesium trisalicylate, idarubicin, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet know whether choline magnesium trisalicylate and combination chemotherapy is more effective than combination chemotherapy alone in treating patients with acute myeloid leukemia.
Eligibility Criteria
Inclusion Criteria
- Patients must have a diagnosis of non-M3 AML (patients with M3 subtype are excluded); determination of the presence of cytogenetic abnormalities will be by standard cytogenetics +/- fluorescent-in-situ (FISH) studies; additional molecular analyses for nucleophosmin (NPM) mutation and fms-related tyrosine kinase 3 (flt3) internal tandem duplication will be obtained as a part of standard care by institutional procedures
- Leukemic blast count > 1500/mm^3 of peripheral blood
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status = 50%
- Women of childbearing potential must have a negative pregnancy test
- No uncontrolled psychiatric illness that the principal investigator feels will compromise obtaining informed consent from a patient
- Patient must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines; patients who do not provide informed consent will not be eligible for the study
Exclusion Criteria
- Any coexisting medical condition or medications precluding full compliance with any of the arms of the study
- Allergies to any investigational drugs and/or to the chemotherapeutic agents
- Allergies to any non-steroidal anti-inflammatory drugs (NSAIDs)/salicylates (e.g., aspirin)
- Endoscopically documented upper or lower gastrointestinal (GI) related hemorrhage within last 6 months; also, patients with a clinical diagnosis of GI bleeding requiring blood transfusions will be excluded
Data sourced from ClinicalTrials.gov (NCT02144675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.