Phase 1 N=40 Treatment

Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Acute Myeloid Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT02971397 ↗

Enrolled (actual)

Serious AEs

100.0%

Results posted

Mar 2026

Primary outcome: Primary: Number of Participants With Cardiac Toxicity, Defined as Reduction in LVEF of >= 10% Compared to Baseline LVEF and EF =< 50% on the Follow-up Scan, Assessed Using MRI — 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Bone Marrow Aspiration and Biopsy (Procedure); Cytarabine (Drug); Daunorubicin Hydrochloride (Drug); Laboratory Biomarker Analysis (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Mar 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Cardiac Toxicity, Defined as Reduction in LVEF of >= 10% Compared to Baseline LVEF and EF =< 50% on the Follow-up Scan, Assessed Using MRI	3	—
PRIMARY Unexpected Toxicities (Exclude Hematologic and Infectious) ≥ Grade 3, as Measured by CTCAE v 4.0	3; 2; 3; 1; 2; 2	—
PRIMARY Proportion of Patients Who Complete the Infusion Therapy	40	—
PRIMARY Proportion of Patients With Study-related Deviations	1	—
PRIMARY Incidence of Cardiac Toxicity, Defined as Reduction in LVEF of >= 10% Compared to Baseline LVEF and EF =< 50% on the Follow-up Scan, Assessed Using ECHO	4	—
SECONDARY EF, Assessed by MRI and ECHO	59.8; 56.7; -4.0; 56.3; 53.6; -3.5	—
SECONDARY Incidence of Cardiac Toxicity, Defined as Reduction in LVEF of >= 10% Compared to Baseline LVEF and EF =< 50% on the Follow-up Scan, Assessed Using MRI	1	—
SECONDARY Change in Left Ventricular End Diastolic Volume, Assessed by MRI and ECHO	140.4; 141.3; 2.5; 98.6; 99.0; -5.2	—
SECONDARY Left Ventricular End Systolic Volume, Assessed by MRI and ECHO	56.9; 60.7; 6.0; 40.1; 40.5; -2.0	—
SECONDARY Myocardial Strain, Assessed by MRI and ECHO	-20.2; -18.5; 1.7	—
SECONDARY Disease-free Survival for Those Patients Who Achieve Remission	16.5	—
SECONDARY Induction Death Rate	5	—
SECONDARY Overall Response Rate, Defined as CR + CRi	23	—

Summary

This pilot clinical trial studies the side effects of cytarabine and daunorubicin hydrochloride and to see how well they work in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as cytarabine and daunorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading, and may be safer for the heart.

Eligibility Criteria

Inclusion Criteria

Patients must have morphologically confirmed newly diagnosed acute myelogenous leukemia (AML) with blood or bone marrow disease; patients with only extramedullary disease in the absence of bone marrow or blood involvement are eligible; note: this protocol uses World Health Organization (WHO) diagnostic criteria for AML; patients with acute promyelocytic leukemia (APL, French-American-British Classification [FAB], M3) or blastic transformation of chronic myelogenous leukemia (CML) are not eligible
Eastern Cooperative Oncology Group (ECOG) performance status 0-3
Patients with ECHO EF >= 45% within 28 days prior to registration
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document

Exclusion Criteria

Patients who have received prior induction chemotherapy for AML or myelodysplastic syndrome (MDS); temporary prior measures such as apheresis or hydroxyurea are allowed; patients who have received a limited and short-term exposure of ATRA (all trans retinoic acid) while AML-M3 (acute promyelocytic leukemia) was being ruled out, and which has been discontinued, will be eligible
Patients receiving any other investigational agents
Patients with prolonged corrected QT (QTc) interval (> 500 msec) determined by electrocardiogram (EKG) within 28 days prior to registration
Patients not suitable for cardiac MRI; contraindications include:
Intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices, or other implanted electronic devices
Ferromagnetic cerebral aneurysm clips, or other intraorbital/intracranial metal
Allergy to gadolinium or other severe drug allergies
Claustrophobia
Congestive heart failure (New York Heart Association [NYHA] class III or IV)
Significant valvular disease, or significant pulmonary disease requiring supplemental oxygen therapy
History of allergic reactions attributed to compounds of similar chemical or biologic composition to daunorubicin or cytarabine
Patients with documented central nervous system (CNS) involvement
Patients who are known to be human immunodeficiency virus (HIV) positive (+) may be eligible providing they meet all of the following additional criteria within 28 days prior to registration:
CD4 cells >= 500/mm^3
Viral load of < 50 copies HIV messenger ribonucleic acid (mRNA)/mm^3 if on combination antiretroviral therapy (cART) or < 25,000 copies HIV mRNA if not on cART
No zidovudine or stavudine as part of cART Patients who are HIV+ and do not meet all of these criteria are not eligible for this study
Patients with other uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study; breastfeeding should be discontinued prior to beginning treatment

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02971397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.