CClinicalTrials.gg
Sign In
CompletedNCT02971397Updated Aug 3, 2026Results posted

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

A Phase 1 interventional study of Bone Marrow Aspiration and Biopsy and Cytarabine in Acute Myeloid Leukemia, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by Wake Forest University Health Sciences · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

PRIMARY OBJECTIVES:

I. To assess the safety (at 3 months) and feasibility of administering daunorubicin hydrochloride (daunorubicin) as continuous infusion under the proposed treatment regimen.

SECONDARY OBJECTIVES:

I. To assess the safety (at 6 months) of administering daunorubicin as continuous infusion under the proposed treatment regimen.

II. To assess treatment outcomes (including complete remission [CR] and complete remission with incomplete recovery [CRi]) in patients with acute myeloid leukemia (AML) under the proposed treatment regimen.

III. To compare the concordance between magnetic resonance imaging (MRI) and echocardiogram (ECHO) in identifying cardiac toxicity, ie a reduction in left ventricular ejection fraction (LVEF) of >= 10% and ejection fraction (EF) =\< 50% compared to baseline LVEF.

OUTLINE:

INDUCTION: Patients receive cytarabine intravenously (IV) continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity >= 10% and > 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with core-binding factor (CBF) AML may receive 4 courses of therapy.

After completion of study treatment, patients are followed up for a minimum of 30 days, at 3 and 6 months, and then every 3 months thereafter.

02

Conditions studied

  • Acute Myeloid Leukemia
03

In context

Leukemia, Myeloid, Acute

2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 745 are open to participants now.

This study's enrollment of 40 is close to the median of 41 across 2,509 interventional studies indexed under Leukemia, Myeloid, Acute.

Browse Leukemia, Myeloid, Acute studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Treatment (cytarabine, daunorubicin hydrochloride, biopsy)

    INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity \>= 10% and \> 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy.

    Procedure: Bone Marrow Aspiration and Biopsy · Drug: Cytarabine · Drug: Daunorubicin Hydrochloride · Other: Laboratory Biomarker Analysis

Interventions

  • ProcedureBone Marrow Aspiration and Biopsy

    Undergo bone marrow aspiration and biopsy

  • DrugCytarabine

    Given IV

    Also known as: .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosar-U, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453

  • DrugDaunorubicin Hydrochloride

    Given IV

    Also known as: Cerubidin, Cerubidine, Cloridrato de Daunorubicina, Daunoblastin, Daunoblastina, Daunoblastine, Daunomycin Hydrochloride, Daunomycin, hydrochloride, Daunorubicin.HCl, Daunorubicini Hydrochloridum, FI-6339, Ondena, RP-13057, Rubidomycin Hydrochloride, Rubilem

  • OtherLaboratory Biomarker Analysis

    Correlative studies

06

What researchers measure

Primary outcomes

  1. 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

    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.

    Time frame: Baseline up to 3 months

  2. Unexpected Toxicities (Exclude Hematologic and Infectious) ≥ Grade 3, as Measured by CTCAE v 4.0

    Unexpected toxicities (exclude hematologic and infectious) ≥ grade 3, as measured by CTCAE v 4.0

    Time frame: Up to 30 days after last dose of study drug

  3. Proportion of Patients Who Complete the Infusion Therapy

    Will report these proportions with 95% confidence intervals.

    Time frame: 72 hours

  4. Proportion of Patients With Study-related Deviations

    Will report these proportions with 95% confidence intervals.

    Time frame: Approximately 1 year, 5 months

  5. 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

    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.

    Time frame: Baseline up to 3 months after last dose of study drug

Secondary outcomes

  1. EF, Assessed by MRI and ECHO

    Ejection Fraction at baseline, 3 months, and change from baseline to 3 months

    Time frame: Baseline and 3 months

  2. 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

    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.

    Time frame: Baseline up to 6 months after last dose of study drug

  3. Change in Left Ventricular End Diastolic Volume, Assessed by MRI and ECHO

    Left ventricular end diastolic volume assessed by MRI and ECHO at baseline, 3 months, and change from baseline to 3 months.

    Time frame: Baseline up to 6 months after last dose of study drug

  4. Left Ventricular End Systolic Volume, Assessed by MRI and ECHO

    Left ventricular end systolic volume assessed by MRI and ECHO at baseline, 3 months, and change from baseline to 3 months.

    Time frame: Baseline, 3 months

  5. Myocardial Strain, Assessed by MRI and ECHO

    Myocardial strain (Global Longitudinal Strain %) assessed by ECHO at baseline, 3 months, and change from baseline to 3 months. GLS was not measured with MRI.

    Time frame: Baseline and 3 months

  6. Disease-free Survival for Those Patients Who Achieve Remission

    Disease-free survival is calculated for patients who achieve CR and measured from the date of CR until relapse from CR or death. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse.

    Time frame: From the date of CR until relapse from CR or death, approximately 1 year, 9 months

  7. Induction Death Rate

    Number of patients who had an induction death

    Time frame: Up to 28 days

  8. Overall Response Rate, Defined as CR + CRi

    Overall response rate, defined as CR + CRi. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.

    Time frame: Approximately 1 year and 9 months

07

Results

Posted Mar 23, 2026

Participant flow

Participant flow — Overall Study
MilestoneTreatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
Started40
Completed12
Not completed28
Withdrew: Lack of efficacy5
Withdrew: Adverse event3
Withdrew: Death7
Withdrew: Withdrawal by subject1
Withdrew: Physician decision12

Outcome measures

PrimaryNumber 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

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.

Time frame:
Baseline up to 3 months
Reported as:
Count of participants · Participants
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
ParticipantsTreatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
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 MRI3
PrimaryUnexpected Toxicities (Exclude Hematologic and Infectious) ≥ Grade 3, as Measured by CTCAE v 4.0

Unexpected toxicities (exclude hematologic and infectious) ≥ grade 3, as measured by CTCAE v 4.0

Time frame:
Up to 30 days after last dose of study drug
Reported as:
Number · events
Unexpected Toxicities (Exclude Hematologic and Infectious) ≥ Grade 3, as Measured by CTCAE v 4.0
eventsTreatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
Alkalosis3
Anxiety2
Atrial fibrillation3
Atrial flutter1
Bone pain2
Cardiac arrest2
Encephalopathy2
Hyperglycemia14
Hypertension25
Hypoglycemia2
Pain2
Ventricular fibrillation1
Ventricular tachycardia2
Blood and lymphatic system disorders - Other: Acute blood loss1
PrimaryProportion of Patients Who Complete the Infusion Therapy

Will report these proportions with 95% confidence intervals.

Time frame:
72 hours
Reported as:
Count of participants · Participants
Proportion of Patients Who Complete the Infusion Therapy
ParticipantsTreatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
Proportion of Patients Who Complete the Infusion Therapy40
PrimaryProportion of Patients With Study-related Deviations

Will report these proportions with 95% confidence intervals.

Time frame:
Approximately 1 year, 5 months
Reported as:
Count of participants · Participants
Proportion of Patients With Study-related Deviations
ParticipantsTreatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
Proportion of Patients With Study-related Deviations1
PrimaryIncidence 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

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.

Time frame:
Baseline up to 3 months after last dose of study drug
Reported as:
Count of participants · Participants
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
ParticipantsTreatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
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 ECHO4
SecondaryEF, Assessed by MRI and ECHO

Ejection Fraction at baseline, 3 months, and change from baseline to 3 months

Time frame:
Baseline and 3 months
Reported as:
Mean · percentage of ejection fraction
EF, Assessed by MRI and ECHO
percentage of ejection fractionTreatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
Baseline MRI59.8 ± 6.3
3 months MRI56.7 ± 7.9
Change from baseline to 3 months MRI-4.0 ± 8.0
Baseline ECHO56.3 ± 5.2
3 months ECHO53.6 ± 8.8
Change from baseline to 3 months ECHO-3.5 ± 8.6
SecondaryIncidence 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

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.

Time frame:
Baseline up to 6 months after last dose of study drug
Reported as:
Count of participants · Participants
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
ParticipantsTreatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
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 MRI1
SecondaryChange in Left Ventricular End Diastolic Volume, Assessed by MRI and ECHO

Left ventricular end diastolic volume assessed by MRI and ECHO at baseline, 3 months, and change from baseline to 3 months.

Time frame:
Baseline up to 6 months after last dose of study drug
Reported as:
Mean · ml
Change in Left Ventricular End Diastolic Volume, Assessed by MRI and ECHO
mlTreatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
Baseline MRI140.4 ± 33.2
3 months MRI141.3 ± 46.5
Change from baseline to 3 months MRI2.5 ± 28.4
Baseline ECHO98.6 ± 31.2
3 month ECHO99.0 ± 35.6
Change from baseline to 3 months ECHO-5.2 ± 35.3
SecondaryLeft Ventricular End Systolic Volume, Assessed by MRI and ECHO

Left ventricular end systolic volume assessed by MRI and ECHO at baseline, 3 months, and change from baseline to 3 months.

Time frame:
Baseline, 3 months
Reported as:
Mean · ml
Left Ventricular End Systolic Volume, Assessed by MRI and ECHO
mlTreatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
Baseline MRI56.9 ± 17.7
3 month MRI60.7 ± 22.0
Change from baseline to 3 months MRI6.0 ± 14.1
Baseline ECHO40.1 ± 15.7
3 months ECHO40.5 ± 14.1
Change from baseline to 3 months ECHO-2.0 ± 17.1
SecondaryMyocardial Strain, Assessed by MRI and ECHO

Myocardial strain (Global Longitudinal Strain %) assessed by ECHO at baseline, 3 months, and change from baseline to 3 months. GLS was not measured with MRI.

Time frame:
Baseline and 3 months
Reported as:
Mean · percentage of original length
Myocardial Strain, Assessed by MRI and ECHO
percentage of original lengthTreatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
Baseline-20.2 ± 2.2
3 months-18.5 ± 2.4
Change: 3 months - baseline1.7 ± 3.2
SecondaryDisease-free Survival for Those Patients Who Achieve Remission

Disease-free survival is calculated for patients who achieve CR and measured from the date of CR until relapse from CR or death. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse.

Time frame:
From the date of CR until relapse from CR or death, approximately 1 year, 9 months
Reported as:
Median · months
Disease-free Survival for Those Patients Who Achieve Remission
monthsTreatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
Disease-free Survival for Those Patients Who Achieve Remission16.5 (2.4 to 24)
SecondaryInduction Death Rate

Number of patients who had an induction death

Time frame:
Up to 28 days
Reported as:
Count of participants · Participants
Induction Death Rate
ParticipantsTreatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
Induction Death Rate5
SecondaryOverall Response Rate, Defined as CR + CRi

Overall response rate, defined as CR + CRi. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.

Time frame:
Approximately 1 year and 9 months
Reported as:
Count of participants · Participants
Overall Response Rate, Defined as CR + CRi
ParticipantsTreatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
Overall Response Rate, Defined as CR + CRi23

Adverse events

Collected over From start of treatment until 30 days post treatment. Average time of 3.4 months with a maximum of 9.4 months.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)9/40 (22.5%)40/40 (100%)40/40 (100%)
Most frequent serious events
Showing 10 of 36
Most frequent serious events
EventTreatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
Platelet count decreasedInvestigations40/40
Neutrophil count decreasedInvestigations39/40
White blood cell decreasedInvestigations37/40
Lymphocyte count decreasedInvestigations32/40
SepsisInfections and infestations8/40
AnemiaBlood and lymphatic system disorders7/40
Respiratory failureRespiratory, thoracic and mediastinal disorders4/40
Cardiac arrestCardiac disorders3/40
Lung infectionInfections and infestations3/40
HyperkalemiaMetabolism and nutrition disorders3/40
Most frequent other events
Showing 10 of 162
Most frequent other events
EventTreatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
HyperglycemiaMetabolism and nutrition disorders39/40
HypoalbuminemiaMetabolism and nutrition disorders37/40
AnorexiaMetabolism and nutrition disorders36/40
HypomagnesemiaMetabolism and nutrition disorders36/40
FatigueGeneral disorders and administration site conditions35/40
HypokalemiaMetabolism and nutrition disorders35/40
AnemiaBlood and lymphatic system disorders32/40
HypocalcemiaMetabolism and nutrition disorders32/40
DiarrheaGastrointestinal disorders31/40
NauseaGastrointestinal disorders31/40

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
Mean60.1 ± 15.5
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
Female22
Male18
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
Hispanic or Latino0
Not Hispanic or Latino40
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment (Cytarabine, Daunorubicin Hydrochloride, Biopsy)
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American7
White33
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • Comprehensive Cancer Center of Wake Forest University
    Winston-Salem, North Carolina 27157, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 2, 2017
  • Informed consent form · Dec 30, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02971397
Lead sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Nov 23, 2016
Start date
Nov 2016
Primary completion
Mar 2018
Completion
Aug 8, 2018
Results posted
Mar 23, 2026
Last update
Aug 3, 2026

Study contacts

Bayard Powell
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Leukemia, Myeloid, Acute→

Other studies from this sponsor

Wake Forest University Health Sciences

Start the discussion