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A Phase I-II Open Label Non-Randomized Study Using TL32711 for Patients With Acute Myelogenous Leukemia, Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia

Phase 1/Phase 2
18 Years
Open (Enrolling)
Acute Myelogenous Leukemia

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Trial Information

A Phase I-II Open Label Non-Randomized Study Using TL32711 for Patients With Acute Myelogenous Leukemia, Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia

This is a phase I/II, open-label, non-randomized study using an investigational new drug, TL
32711, in patients with acute myelogenous leukemia. This study will target subjects 60
years of age and older (with non-M3 AML who have relapsed or refractory disease after
standard therapy or who are newly diagnosed and not candidates for standard induction
therapy) and subjects 18-59 (relapsed or refractory after failing 3 prior lines of therapy).
Subjects would receive the study drug in 4 weeks dosing periods via one of three different
treatment schedules (once weekly, twice weekly or three times weekly dosing). They will
receive treatment for up to 6 cycles, however treatment may be extended at the discretion of
the study doctor if felt to be in the best interest of the subject. Up to 46 subjects will
be enrolled on this study at the University of Pennsylvania, depending on the number of
subjects needed in the Phase I component in order to determine the MTD. The primary
objective of the Phase 1 component of this study is to determine the safety and tolerability
of TL32711, and the MTD in this patient population. The primary objective of the Phase 2
portion of this study is further define the safety and tolerability, and provide preliminary
efficacy data.

Inclusion Criteria

Inclusion criteria

- Subjects with a diagnosis of non-M3 AML, Relapsed or refractory ALL or Intermediate
Risk 2 or High Risk disease MDS as follows:

- Subjects with a diagnosis of non-M3 AML which meets one of the following criteria:

1. Ages 60 or older: Relapsed or refractory after at least one prior therapy for

2. Ages 60 or older: Newly diagnosed in a patient with a preceding history of
myelodysplastic syndrome which has been treated with azacitidine or decitabine
and who are not appropriate candidates for aggressive therapy including
induction followed by allogeneic stem cell transplantation.

3. Ages 18-59: Relapsed or refractory disease after failing three prior lines of

- Subjects with a diagnosis of relapsed or refractory ALL: must have failed three prior
lines of therapy and be 18 years of age or older.

- Subjects with a diagnosis of Intermediate Risk 2 or High Risk disease (as defined by
IPSS score): must have failed to respond/intolerant to, or progressed after a
hypomethylating agent, and must not be candidates for allogeneic stem cell

2). Life expectancy of at least 4 weeks 3). Must have recovered from toxic effects of
prior chemotherapy 4). Patients must be able to sign consent and be willing and able
to comply with scheduled visits, treatment plan and laboratory testing.

Exclusion criteria

1. . Cytotoxic chemotherapy (including azacitadine or decitabine) within the past 28
days other than hydroxyurea

2. . Active participation in any other investigational treatment study for AML.

3. . ECOG performance status greater than 2

4. . Uncontrolled intercurrent illness including, but not limited to: uncontrolled
ongoing infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements.

5. . QT interval corrected for heart rate (QTcB) greater than 480 msec (including
subjects on medication). Subjects with a ventricular pacemaker for whom QT interval
is not measurable may be eligible for enrollment after consultation with the drug
manufacturer and study Medical Monitor, and written documentation of this approval.

6. . Female subjects who are pregnant or breastfeeding

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Outcome Measure:

Adverse Events

Safety Issue:



United States: Food and Drug Administration

Study ID:

UPCC 15411



Start Date:

November 2011

Completion Date:

December 2014

Related Keywords:

  • Acute Myelogenous Leukemia
  • equal to or greater than age 60 years
  • non-M3 AML
  • relapsed disease
  • primary refractory disease
  • not appropriate or willing candidates for aggressive therapy
  • AML
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia



Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283