Trial Outcomes & Findings for Choline Magnesium Trisalicylate and Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia (NCT NCT02144675)

Last Updated: 2021-08-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

24 hours

Results posted on

2021-08-24

Participant Flow

Subjects were recruited through the Rutgers Cancer Institute of New Jersey. The study was open to accrual on 10/31/2008 and completed on 01/06/2015. All participants visits were completed and the study was closed by the Principal Investigator on 04/26/2016.

Participant milestones

Participant milestones
Measure	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. choline magnesium trisalicylate: Given PO idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies	Arm II (Chemotherapy) Patients receive idarubicin IV on days 1- 3 and cytarabine IV continuously on days 1-7. idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies
Overall Study STARTED	13	14
Overall Study COMPLETED	13	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Choline Magnesium Trisalicylate and Chemotherapy) n=13 Participants 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. choline magnesium trisalicylate: Given PO idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies	Arm II (Chemotherapy) n=14 Participants Patients receive idarubicin IV on days 1- 3 and cytarabine IV continuously on days 1-7. idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Outcome measures

Outcome measures
Measure	Arm I (Choline Magnesium Trisalicylate and Chemotherapy) n=13 Participants 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. choline magnesium trisalicylate: Given PO idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies	Arm II (Chemotherapy) n=14 Participants Patients receive idarubicin IV on days 1- 3 and cytarabine IV continuously on days 1-7. idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies
Inhibition of NF-kB Target Transcripts and/or Inhibition of Drug Efflux in at Least 50% of Patients	13 Participants	14 Participants

Adverse Events

Arm I (Choline Magnesium Trisalicylate and Chemotherapy)

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Arm II (Chemotherapy)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Choline Magnesium Trisalicylate and Chemotherapy) n=13 participants at risk 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. choline magnesium trisalicylate: Given PO idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies	Arm II (Chemotherapy) n=14 participants at risk Patients receive idarubicin IV on days 1- 3 and cytarabine IV continuously on days 1-7. idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.	0.00% 0/14 • Adverse events were collected over a period of approximately 1.5 months.

Other adverse events

Additional Information

Roger Strair, MD, PhD

Rutgers Cancer Institute of New Jersey

Phone: 732-235-7298

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm I (Choline Magnesium Trisalicylate and Chemotherapy) n=13 participants at risk 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. choline magnesium trisalicylate: Given PO idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies	Arm II (Chemotherapy) n=14 participants at risk Patients receive idarubicin IV on days 1- 3 and cytarabine IV continuously on days 1-7. idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies
Blood and lymphatic system disorders Alkalosis (metabolic or respiratory)	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.	0.00% 0/14 • Adverse events were collected over a period of approximately 1.5 months.
Blood and lymphatic system disorders Dermal change lymphedema, phlebolymphedema	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.	0.00% 0/14 • Adverse events were collected over a period of approximately 1.5 months.
Gastrointestinal disorders Constipation	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.	0.00% 0/14 • Adverse events were collected over a period of approximately 1.5 months.
Gastrointestinal disorders Colitis	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.	0.00% 0/14 • Adverse events were collected over a period of approximately 1.5 months.
Gastrointestinal disorders Diarrhea	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.	14.3% 2/14 • Number of events 2 • Adverse events were collected over a period of approximately 1.5 months.
Skin and subcutaneous tissue disorders Rash	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.	21.4% 3/14 • Number of events 3 • Adverse events were collected over a period of approximately 1.5 months.
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.	0.00% 0/14 • Adverse events were collected over a period of approximately 1.5 months.
Blood and lymphatic system disorders Low Platelets	15.4% 2/13 • Number of events 2 • Adverse events were collected over a period of approximately 1.5 months.	14.3% 2/14 • Number of events 2 • Adverse events were collected over a period of approximately 1.5 months.
Infections and infestations Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.	28.6% 4/14 • Number of events 4 • Adverse events were collected over a period of approximately 1.5 months.
Blood and lymphatic system disorders Low Hemoglobin	23.1% 3/13 • Number of events 3 • Adverse events were collected over a period of approximately 1.5 months.	21.4% 3/14 • Number of events 3 • Adverse events were collected over a period of approximately 1.5 months.
Blood and lymphatic system disorders Neutropenia	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.	0.00% 0/14 • Adverse events were collected over a period of approximately 1.5 months.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.	0.00% 0/14 • Adverse events were collected over a period of approximately 1.5 months.
General disorders Glucose, serum-high (hyperglycemia)	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.	0.00% 0/14 • Adverse events were collected over a period of approximately 1.5 months.
General disorders Potassium, serum-low (hypokalemia)	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.	0.00% 0/14 • Adverse events were collected over a period of approximately 1.5 months.
General disorders Calcium, serum-low (hypocalcemia)	7.7% 1/13 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.	0.00% 0/14 • Adverse events were collected over a period of approximately 1.5 months.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	0.00% 0/13 • Adverse events were collected over a period of approximately 1.5 months.	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.
Vascular disorders Hypotension	0.00% 0/13 • Adverse events were collected over a period of approximately 1.5 months.	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.
Gastrointestinal disorders Nausea	0.00% 0/13 • Adverse events were collected over a period of approximately 1.5 months.	14.3% 2/14 • Number of events 2 • Adverse events were collected over a period of approximately 1.5 months.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	0.00% 0/13 • Adverse events were collected over a period of approximately 1.5 months.	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.
Gastrointestinal disorders Heartburn/dyspepsia	0.00% 0/13 • Adverse events were collected over a period of approximately 1.5 months.	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.
Gastrointestinal disorders Enteritis (inflammation of the small bowel)	0.00% 0/13 • Adverse events were collected over a period of approximately 1.5 months.	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.
Gastrointestinal disorders Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)	0.00% 0/13 • Adverse events were collected over a period of approximately 1.5 months.	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.
Infections and infestations Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e	0.00% 0/13 • Adverse events were collected over a period of approximately 1.5 months.	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.
Renal and urinary disorders Cystitis	0.00% 0/13 • Adverse events were collected over a period of approximately 1.5 months.	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/13 • Adverse events were collected over a period of approximately 1.5 months.	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	0.00% 0/13 • Adverse events were collected over a period of approximately 1.5 months.	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.
General disorders Pain - Abdomen NOS	0.00% 0/13 • Adverse events were collected over a period of approximately 1.5 months.	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	0.00% 0/13 • Adverse events were collected over a period of approximately 1.5 months.	14.3% 2/14 • Number of events 2 • Adverse events were collected over a period of approximately 1.5 months.
General disorders Pain - Head/headache	0.00% 0/13 • Adverse events were collected over a period of approximately 1.5 months.	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.
General disorders Pain - Sore Throat	0.00% 0/13 • Adverse events were collected over a period of approximately 1.5 months.	7.1% 1/14 • Number of events 1 • Adverse events were collected over a period of approximately 1.5 months.