Clinical trial · Interventional
Gene Expression During Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Treated With Choline Magnesium Trisalicylate
A Pilot Study of Nuclear Factor-kappa B (NFkB) Inhibition During Induction Chemotherapy for Patients With Acute Myelogenous Leukemia (AML)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Replaced by another study
Summary
Brief summary (as posted)
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in cancer cells. It may also help doctors understand how cancer cells respond to treatment with choline magnesium trisalicylate. PURPOSE: This pilot clinical trial is studying gene expression in cancer cells during chemotherapy and the safety of choline magnesium trisalicylate in treating patients with newly diagnosed acute myeloid leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| choline magnesium trisalicylate | Drug | — | UNRESOLVED |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dexamethasone plus Choline Magnesium Trisalicylate
- description
- Dexamethasone plus Choline Magnesium Trisalicylate
- interventionNames
- Drug: choline magnesium trisalicylate
- Drug: Dexamethasone
- type
- EXPERIMENTAL
- label
- Choline Magnesium Trisalicylate
- description
- Choline Magnesium Trisalicylate
- interventionNames
- Drug: choline magnesium trisalicylate
Primary outcomes (1)
- measure
- Temporal changes in leukemic cell NF-kB activity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed acute myeloid leukemia * Newly diagnosed disease * Presence of cytogenetic abnormalities must be determined by standard cytogenetics with or without FISH studies * Leukemic blast count \> 5,000/mm³ of peripheral blood * No acute promyelocytic leukemia (M3) PATIENT CHARACTERISTICS: * ECOG performance status 0-3 * Bilirubin \< 2.0 times upper limit of normal (ULN) * AST \< 3.0 times ULN * Creatinine \< 1.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled psychiatric illness that, in the opinion of the principal investigator, would preclude study compliance * No other concurrent medical condition that would preclude study compliance * No allergies to any investigational drugs and/or chemotherapeutic agents * No upper or lower gastrointestinal (GI) related hemorrhage within the past 6 months as determined by endoscopy * No clinical diagnosis of GI bleeding requiring blood transfusions PRIOR CONCURRENT THERAPY: * No prior induction therapy * No prior chemotherapy for acute leukemia * No concurrent medications that would preclude study compliance
References
Publications (1)
- RESULTStrair RK, Gharibo M, Schaar D, Rubin A, Harrison J, Aisner J, Lin HC, Lin Y, Goodell L, Anand M, Balsara B, Dudek L, Rabson A, Medina DJ. Nuclear factor-kappaB modulation in patients undergoing induction chemotherapy for acute myelogenous leukemia. Clin Cancer Res. 2008 Nov 15;14(22):7564-8. doi: 10.1158/1078-0432.CCR-08-1390. PMID 19010875