Choline Magnesium Trisalicylate and Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia

NCT02144675 | Completed Phase 2 Results

• 4 other identifiers: 0220080282NCI-2012-00516P30CA072720020803
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Recurrent Adult Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Inhibition of NF-kB Target Transcripts and/or Inhibition of Drug Efflux in at Least 50% of Patients

  The clinical trial will be based on a sequential monitoring so that we will have a 90% confidence that choline magnesium trisalicylate (CMT) based modulation of NF-kB transcriptional targets and/or drug efflux occurs in at least 50% of patients.

  24 hours

Study Arms (2)

Arm I (choline magnesium trisalicylate and chemotherapy)

EXPERIMENTAL

Patients receive choline magnesium trisalicylate PO every 8 hours on days 0-7, idarubicin IV on days 1-3, and cytarabine IV continuously on days 1-7.

Drug: choline magnesium trisalicylate; Drug: idarubicin; Drug: cytarabine; Other: laboratory biomarker analysis

Arm II (chemotherapy)

ACTIVE COMPARATOR

Patients receive idarubicin IV on days 1- 3 and cytarabine IV continuously on days 1-7.

Drug: idarubicin; Drug: cytarabine; Other: laboratory biomarker analysis

Interventions

choline magnesium trisalicylate DRUG

Given PO

Also known as: Trilisate, Trisalicylate

Arm I (choline magnesium trisalicylate and chemotherapy)

idarubicin DRUG

Given IV

Also known as: 4-demethoxydaunorubicin, 4-DMDR, DMDR, IDA

Arm I (choline magnesium trisalicylate and chemotherapy); Arm II (chemotherapy)

cytarabine DRUG

Given IV

Also known as: ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U, cytosine arabinoside

Arm I (choline magnesium trisalicylate and chemotherapy); Arm II (chemotherapy)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (choline magnesium trisalicylate and chemotherapy); Arm II (chemotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 =\< 3
• Total bilirubin \< 2 times the institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) \< 3 times the institutional ULN
• Serum creatinine \< 1.5 times the institutional ULN
• Multi gated acquisition scan (MUGA) or echocardiogram with left ventricular ejection fraction (LVEF) \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Rutgers Cancer Institute of New Jersey: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Leukemia, Megakaryoblastic, Acute; Leukemia, Monocytic, Acute; Leukemia, Myeloid, Acute; Congenital Abnormalities; Leukemia, Myelomonocytic, Acute; Leukemia, Erythroblastic, Acute

Interventions

choline magnesium trisalicylate; Idarubicin; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Myeloproliferative Disorders; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Roger Strair, MD, PhD
• Organization: Rutgers Cancer Institute of New Jersey

strairrk@cinj.rutgers.edu

732-235-7298

Study Officials

• Roger Strair

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, RWJMS

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: May 22, 2014
• Study Start: January 1, 2009
• Primary Completion: April 26, 2016
• Study Completion: April 26, 2016
• Last Updated: August 24, 2021
• Results First Posted: July 24, 2018

Record last verified: 2021-08

Locations

US (1)