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Low-Dose Daunorubicin Hydrochloride in Treating Patients with Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

Trial Status: Active

This phase I trial studies how well low-dose daunorubicin hydrochloride works in treating patients with acute myeloid leukemia or acute lymphoblastic leukemia that has come back or has not responded to treatment. Drugs used in chemotherapy, such as 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.

Inclusion Criteria

  • Ability to understand and the willingness to sign a written informed consent or have parental consent
  • Pathological confirmation by bone marrow documenting the following: * Acute myeloid leukemia (AML) which has relapsed after complete remission * AML which has been refractory to two prior induction attempts * Acute lymphoblastic leukemia (ALL) which has relapsed after complete remission * ALL which has been refractory to two prior induction attempts
  • Disease status allows delay of additional anti-leukemia therapy for the duration of the study (hydroxyurea is allowed for control of white blood cell count [WBC] throughout study)
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3
  • Able to adhere to the study visit schedule and other protocol requirements
  • Cardiac ejection fraction >= 45% by echocardiogram (ECHO)
  • Serum alanine aminotransferase or aspartate aminotransferase < 3 times the upper limit of normal (ULN)
  • Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: ** Has not undergone a hysterectomy or bilateral oophorectomy or ** Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

Exclusion Criteria

  • Concurrent use of conventional or investigational anticancer agents, except hydroxyurea
  • Patient has received chemotherapy or radiotherapy within 2 weeks prior to entering the study or has not recovered from adverse events due to agents administered more than 2 weeks earlier, with the exception of hydroxyurea
  • Patients with known active uncontrolled central nervous system (CNS) leukemia
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to daunorubicin
  • Patients with a total lifetime anthracycline exposure exceeding the equivalent of 900 mg/m^2 of daunorubicin
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Unwilling or unable to undergo serial bone marrow aspirate/biopsy
  • Pregnant or nursing


Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Raymond P. Perez
Phone: 913-945-7552


I. To determine the molecular pharmacodynamic effects of low dose daunorubicin hydrochloride (daunorubicin) on beta-catenin phosphorylation in serial bone marrow samples of patients with relapsed leukemia.


I. To demonstrate the safety and feasibility of low-dose daunorubicin hydrochloride (DNR) administration in patients with relapsed/refractory acute leukemia.

II. To measure the pharmacokinetics of low dose DNR.

III. To demonstrate the feasibility of measuring beta-catenin expression by immunohistochemistry on bone marrow and peripheral blood samples at serial time points.


I. To observe treatment effects on the leukemia stem cell population in serial bone marrow specimens.

II. To observe the relationship between pretreatment MDR1/Pgp protein levels by immunohistochemistry (IHC) and treatment effects.

III. To quantify daunorubicin-induced deoxyribonucleic acid (DNA) damage on serial marrows specimens by IHC of p-gH2Ax foci.


Patients receive daunorubicin hydrochloride intravenously (IV) on days 1-5 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up on day 8.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
University of Kansas Cancer Center

Principal Investigator
Raymond P. Perez

  • Primary ID IIT-2016-RP-HEM-LD-DNR
  • Secondary IDs NCI-2016-01977, STUDY00004137
  • ID NCT02914977