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

NCT02971397 | Completed Phase 1 Results DMC FDA Drug

• 4 other identifiers: IRB00040792NCI-2016-01464CCCWFU 22616P30CA012197
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline up to 3 months

• 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

  Up to 30 days after last dose of study drug

• Proportion of Patients Who Complete the Infusion Therapy

  Will report these proportions with 95% confidence intervals.

  72 hours

• Proportion of Patients With Study-related Deviations

  Will report these proportions with 95% confidence intervals.

  Approximately 1 year, 5 months

• 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.

  Baseline up to 3 months after last dose of study drug

Secondary Outcomes (8)

• EF, Assessed by MRI and ECHO

  Baseline and 3 months

• 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

  Baseline up to 6 months after last dose of study drug

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

  Baseline up to 6 months after last dose of study drug

• Left Ventricular End Systolic Volume, Assessed by MRI and ECHO

  Baseline, 3 months

• Myocardial Strain, Assessed by MRI and ECHO

  Baseline and 3 months

Study Arms (1)

Treatment (cytarabine, daunorubicin hydrochloride, biopsy)

EXPERIMENTAL

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

Bone Marrow Aspiration and Biopsy PROCEDURE

Undergo bone marrow aspiration and biopsy

Treatment (cytarabine, daunorubicin hydrochloride, biopsy)

Cytarabine DRUG

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

Treatment (cytarabine, daunorubicin hydrochloride, biopsy)

Daunorubicin Hydrochloride DRUG

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

Treatment (cytarabine, daunorubicin hydrochloride, biopsy)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (cytarabine, daunorubicin hydrochloride, biopsy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Biopsy; Cytarabine; Daunorubicin

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Principal Investigator
• Organization: Wake Forest Baptist Comprehensive Cancer Center

bpowell@wakehealth.edu

336-716-4464

Study Officials

• Bayard Powell

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: November 23, 2016
• Study Start: November 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: August 8, 2018
• Last Updated: March 23, 2026
• Results First Posted: March 23, 2026

Record last verified: 2026-03

Locations

US (1)