- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02144675
Choline Magnesium Trisalicylate and Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia
A Randomized Phase II Study of Nuclear Factor-kappa B (NF-κB) Inhibition During Induction Chemotherapy for Patients With Acute Myelogenous Leukemia
Study Overview
Status
Conditions
- Recurrent Adult 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)
- Adult Acute Myeloblastic Leukemia Without Maturation (M1)
- 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)
- Untreated Adult Acute Myeloid Leukemia
- Adult Acute Myeloid Leukemia in Remission
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To determine temporal changes in leukemic cell nuclear factor of kappa light chain enhancer of B-cells 1 (NF-kB) activity when salicylate (choline magnesium trisalicylate) is administered to patients with acute myeloid leukemia (AML) during induction chemotherapy.
II. To determine toxicities associated with administration of salicylate in the setting of induction chemotherapy.
III. To determine if salicylate alters the expression of NF-kB-regulated genes in AML cells.
IV. To determine if NF-kB modulation by salicylate alters AML chemotherapy drug efflux.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive choline magnesium trisalicylate orally (PO) every 8 hours on days 0-7, idarubicin intravenously (IV) on days 1-3, and cytarabine IV continuously on days 1-7.
ARM II: Patients receive idarubicin IV on days 1-3 and cytarabine IV continuously on days 1-7.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08903
- Rutgers Cancer Institute of New Jersey
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 =< 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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (choline magnesium trisalicylate and chemotherapy)
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.
|
Correlative studies
Given IV
Other Names:
Given IV
Other Names:
Given PO
Other Names:
|
Active Comparator: Arm II (chemotherapy)
Patients receive idarubicin IV on days 1- 3 and cytarabine IV continuously on days 1-7.
|
Correlative studies
Given IV
Other Names:
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inhibition of NF-kB Target Transcripts and/or Inhibition of Drug Efflux in at Least 50% of Patients
Time Frame: 24 hours
|
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Leukemia, Myelomonocytic, Acute
- Leukemia, Monocytic, Acute
- Leukemia, Megakaryoblastic, Acute
- Leukemia, Erythroblastic, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Hypolipidemic Agents
- Lipid Regulating Agents
- Antibiotics, Antineoplastic
- Nootropic Agents
- Lipotropic Agents
- Cytarabine
- Idarubicin
- Choline
- Salicylates
- Choline magnesium trisalicylate
Other Study ID Numbers
- 0220080282 (Other Identifier: IRB number)
- P30CA072720 (U.S. NIH Grant/Contract)
- NCI-2012-00516 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 020803 (Other Identifier: Rutgers Cancer Institute of New Jersey)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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