A Phase 2 interventional study of choline magnesium trisalicylate and idarubicin in Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0) and Adult Acute Monoblastic Leukemia (M5a), sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-24.
Sponsored by Rutgers, The State University of New Jersey · Phase 2, Interventional, and Treatment
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.
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.
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This study's enrollment of 27 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
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Exclusion Criteria:
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
Patients receive idarubicin IV on days 1- 3 and cytarabine IV continuously on days 1-7.
Drug: idarubicin · Drug: cytarabine · Other: laboratory biomarker analysis
Given PO
Also known as: Trilisate, Trisalicylate
Given IV
Also known as: 4-demethoxydaunorubicin, 4-DMDR, DMDR, IDA
Given IV
Also known as: ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U, cytosine arabinoside
Correlative studies
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.
Time frame: 24 hours
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.
| Milestone | Arm I (Choline Magnesium Trisalicylate and Chemotherapy) | Arm II (Chemotherapy) |
|---|---|---|
| Started | 13 | 14 |
| Completed | 13 | 14 |
| Not completed | 0 | 0 |
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.
| Participants | Arm I (Choline Magnesium Trisalicylate and Chemotherapy) | Arm II (Chemotherapy) |
|---|---|---|
| Inhibition of NF-kB Target Transcripts and/or Inhibition of Drug Efflux in at Least 50% of Patients | 13 | 14 |
Collected over Adverse events were collected over a period of approximately 1.5 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I (Choline Magnesium Trisalicylate and Chemotherapy) | 0/13 (0%) | 1/13 (7.7%) | 7/13 (53.8%) |
| Arm II (Chemotherapy) | 0/14 (0%) | 0/14 (0%) | 10/14 (71.4%) |
| Event | Arm I (Choline Magnesium Trisalicylate and Chemotherapy) | Arm II (Chemotherapy) |
|---|---|---|
| Pneumonitis/pulmonary infiltratesRespiratory, thoracic and mediastinal disorders | 1/13 | 0/14 |
| Event | Arm I (Choline Magnesium Trisalicylate and Chemotherapy) | Arm II (Chemotherapy) |
|---|---|---|
| Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infeInfections and infestations | 1/13 | 4/14 |
| Low HemoglobinBlood and lymphatic system disorders | 3/13 | 3/14 |
| RashSkin and subcutaneous tissue disorders | 1/13 | 3/14 |
| Low PlateletsBlood and lymphatic system disorders | 2/13 | 2/14 |
| DiarrheaGastrointestinal disorders | 1/13 | 2/14 |
| NauseaGastrointestinal disorders | 0/13 | 2/14 |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)General disorders | 0/13 | 2/14 |
| Alkalosis (metabolic or respiratory)Blood and lymphatic system disorders | 1/13 | 0/14 |
| Dermal change lymphedema, phlebolymphedemaBlood and lymphatic system disorders | 1/13 | 0/14 |
| ConstipationGastrointestinal disorders | 1/13 | 0/14 |
| Age, Categorical(Participants) | Arm I (Choline Magnesium Trisalicylate and Chemotherapy) | Arm II (Chemotherapy) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 9 | 19 |
| >=65 years | 3 | 5 | 8 |
| Sex: Female, Male(Participants) | Arm I (Choline Magnesium Trisalicylate and Chemotherapy) | Arm II (Chemotherapy) | Total |
|---|---|---|---|
| Female | 6 | 10 | 16 |
| Male | 7 | 4 | 11 |
| Ethnicity (NIH/OMB)(Participants) | Arm I (Choline Magnesium Trisalicylate and Chemotherapy) | Arm II (Chemotherapy) | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 12 | 14 | 26 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm I (Choline Magnesium Trisalicylate and Chemotherapy) | Arm II (Chemotherapy) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 2 |
| White | 11 | 13 | 24 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Arm I (Choline Magnesium Trisalicylate and Chemotherapy) | Arm II (Chemotherapy) | Total |
|---|---|---|---|
| United States | 13 | 14 | 27 |
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