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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02144675
Recruitment Status : Completed
First Posted : May 22, 2014
Results First Posted : July 24, 2018
Last Update Posted : July 24, 2018
Sponsor:
Collaborators:
Rutgers Cancer Institute of New Jersey
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roger Strair, MD, PhD, Rutgers Cancer Institute of New Jersey

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
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
Interventions Drug: choline magnesium trisalicylate
Drug: idarubicin
Drug: cytarabine
Other: laboratory biomarker analysis
Enrollment 27
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Arm I (Choline Magnesium Trisalicylate and Chemotherapy) Arm II (Chemotherapy)
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 13 14
Completed 13 14
Not Completed 0 0
Arm/Group Title Arm I (Choline Magnesium Trisalicylate and Chemotherapy) Arm II (Chemotherapy) Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 13 14 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  76.9%
9
  64.3%
19
  70.4%
>=65 years
3
  23.1%
5
  35.7%
8
  29.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
Female
6
  46.2%
10
  71.4%
16
  59.3%
Male
7
  53.8%
4
  28.6%
11
  40.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
Hispanic or Latino
1
   7.7%
0
   0.0%
1
   3.7%
Not Hispanic or Latino
12
  92.3%
14
 100.0%
26
  96.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   7.1%
1
   3.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  15.4%
0
   0.0%
2
   7.4%
White
11
  84.6%
13
  92.9%
24
  88.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 13 participants 14 participants 27 participants
13
 100.0%
14
 100.0%
27
 100.0%
1.Primary Outcome
Title Inhibition of NF-kB Target Transcripts and/or Inhibition of Drug Efflux in at Least 50% of Patients
Hide Description 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.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Choline Magnesium Trisalicylate and Chemotherapy) Arm II (Chemotherapy)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 13 14
Measure Type: Count of Participants
Unit of Measure: Participants
13
 100.0%
14
 100.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Choline Magnesium Trisalicylate and Chemotherapy), Arm II (Chemotherapy)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Time Frame Adverse events were collected over a period of approximately 1.5 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Choline Magnesium Trisalicylate and Chemotherapy) Arm II (Chemotherapy)
Hide Arm/Group Description

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

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

All-Cause Mortality
Arm I (Choline Magnesium Trisalicylate and Chemotherapy) Arm II (Chemotherapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)      0/14 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Choline Magnesium Trisalicylate and Chemotherapy) Arm II (Chemotherapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/13 (7.69%)      0/14 (0.00%)    
Respiratory, thoracic and mediastinal disorders     
Pneumonitis/pulmonary infiltrates   1/13 (7.69%)  1 0/14 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Choline Magnesium Trisalicylate and Chemotherapy) Arm II (Chemotherapy)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/13 (53.85%)      10/14 (71.43%)    
Blood and lymphatic system disorders     
Alkalosis (metabolic or respiratory) *  1/13 (7.69%)  1 0/14 (0.00%)  0
Dermal change lymphedema, phlebolymphedema *  1/13 (7.69%)  1 0/14 (0.00%)  0
Low Platelets   2/13 (15.38%)  2 2/14 (14.29%)  2
Low Hemoglobin   3/13 (23.08%)  3 3/14 (21.43%)  3
Neutropenia   1/13 (7.69%)  1 0/14 (0.00%)  0
Neutrophils/granulocytes (ANC/AGC)   0/13 (0.00%)  0 1/14 (7.14%)  1
Gastrointestinal disorders     
Constipation *  1/13 (7.69%)  1 0/14 (0.00%)  0
Colitis   1/13 (7.69%)  1 0/14 (0.00%)  0
Diarrhea   1/13 (7.69%)  1 2/14 (14.29%)  2
Nausea   0/13 (0.00%)  0 2/14 (14.29%)  2
Mucositis/stomatitis (clinical exam) - Oral cavity   0/13 (0.00%)  0 1/14 (7.14%)  1
Heartburn/dyspepsia   0/13 (0.00%)  0 1/14 (7.14%)  1
Enteritis (inflammation of the small bowel)   0/13 (0.00%)  0 1/14 (7.14%)  1
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)   0/13 (0.00%)  0 1/14 (7.14%)  1
General disorders     
Glucose, serum-high (hyperglycemia)   1/13 (7.69%)  1 0/14 (0.00%)  0
Potassium, serum-low (hypokalemia)   1/13 (7.69%)  1 0/14 (0.00%)  0
Calcium, serum-low (hypocalcemia)   1/13 (7.69%)  1 0/14 (0.00%)  0
Pain - Abdomen NOS   0/13 (0.00%)  0 1/14 (7.14%)  1
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)   0/13 (0.00%)  0 2/14 (14.29%)  2
Pain - Head/headache   0/13 (0.00%)  0 1/14 (7.14%)  1
Pain - Sore Throat   0/13 (0.00%)  0 1/14 (7.14%)  1
Immune system disorders     
Allergic reaction/hypersensitivity (including drug fever)   1/13 (7.69%)  1 0/14 (0.00%)  0
Infections and infestations     
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe   1/13 (7.69%)  1 4/14 (28.57%)  4
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)   1/13 (7.69%)  1 0/14 (0.00%)  0
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e   0/13 (0.00%)  0 1/14 (7.14%)  1
Renal and urinary disorders     
Cystitis   0/13 (0.00%)  0 1/14 (7.14%)  1
Respiratory, thoracic and mediastinal disorders     
Hypoxia   0/13 (0.00%)  0 1/14 (7.14%)  1
Dyspnea (shortness of breath)   0/13 (0.00%)  0 1/14 (7.14%)  1
Skin and subcutaneous tissue disorders     
Rash   1/13 (7.69%)  1 3/14 (21.43%)  3
Vascular disorders     
Hypotension   0/13 (0.00%)  0 1/14 (7.14%)  1
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Roger Strair, MD, PhD
Organization: Rutgers Cancer Institute of New Jersey
Phone: 732-235-7298
Responsible Party: Roger Strair, MD, PhD, Rutgers Cancer Institute of New Jersey
ClinicalTrials.gov Identifier: NCT02144675     History of Changes
Other Study ID Numbers: 020803
NCI-2012-00516 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
0220080282 ( Other Identifier: IRB number )
P30CA072720 ( U.S. NIH Grant/Contract )
First Submitted: May 20, 2014
First Posted: May 22, 2014
Results First Submitted: March 20, 2017
Results First Posted: July 24, 2018
Last Update Posted: July 24, 2018