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An Open-Label, Single-Arm, Multi-Center, Phase II Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Patients With Acute Myeloid Leukemia (AML) in Second Salvage

Phase 2
18 Years
Not Enrolling
Leukemia, Myeloid, Acute

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Trial Information

An Open-Label, Single-Arm, Multi-Center, Phase II Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Patients With Acute Myeloid Leukemia (AML) in Second Salvage

This is a phase 2, single-arm, open-label, multi-center study to establish the safety and
efficacy of Troxatyl™ (troxacitabine) administered as a continuous infusion for 5 days to
subjects with AML. The study will primarily assess the complete response (CR) rate of a
5-day continuous infusion of troxacitabine at 12 mg/m2/day given as second salvage therapy
in adult patients with AML, with secondary objectives to determine the overall, relapse-free
and event-free survival and remission duration; to determine the duration of response; to
determine the complete response with incomplete platelet recovery (CRp) rate; to evaluate
the tolerability and safety of 5-day continuous intravenous (IV) infusion of troxacitabine;
and to determine the relationship between troxacitabine plasma concentrations, anti-leukemic
activity and adverse events. Additional cycles of treatment may be given at the
investigator’s discretion, provided that the subject does not have progressive disease or
experience a dose limiting toxicity. Bone marrow transplantation in responding subjects will
be allowed.

Inclusion Criteria:

- Confirmed diagnosis of acute myeloid leukemia (AML) in the second salvage setting:
refractory to two prior courses of therapy or primary refractory without response to
two previous courses of leukemia therapy.

- Patients must have received at least two previous courses of induction chemotherapy
to be considered in the second salvage setting.

- Patients who are in second relapse, must have had a duration of their second CR or
CRp of less than six months.

- Subjects must have adequate organ and immune function as indicated by the following
laboratory values:

- Creatinine clearance ≥ 45 mL/min and ≤ 125 mL/min;

- Total bilirubin ≤ 2.0 mg/dL (≤ 34.2 µmol/L);

- AST (SGOT) and ALT (SGPT) ≤ 3 x upper limit of normal (ULN).

- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance
status of < 2, and an estimated life expectancy of at least eight weeks.

Exclusion Criteria:

- Clinical evidence of active central nervous system (CNS) leukemic involvement

- Active and uncontrolled infection

- Uncontrolled medical problems unrelated to the malignancy that impair patient ability
to give informed consent or unacceptably reduce the safety of the proposed treatment

- Neurologic or psychiatric disorders that would interfere with informed consent or
study follow-up

- Known or suspected intolerance or hypersensitivity to Troxatyl® or closely related
compounds such as lamivudine or any of the stated ingredients

- A recent history of alcohol or other substance abuse

- Subjects who have used another investigational agent or participated in a clinical
trial within the last 14 days prior to enrolment

- Females with a positive pregnancy test at screening

- Subjects who have previously been enrolled into this study and subsequently withdrew

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine complete response (CR) rate

Principal Investigator

Francis Giles, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 2005

Completion Date:

October 2007

Related Keywords:

  • Leukemia, Myeloid, Acute
  • Acute myeloid leukemia
  • AML
  • refractory
  • relapsed
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



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