Status:
TERMINATED
A Phase I-II Open Label Non-Randomized Study Using TL32711 for Patients With Acute Myelogenous Leukemia, Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Acute Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This was initially a phase I/II, open-label non-randomized study using an investigational new drug, TL32711, in patients with AML, MDS and ALL, however, the phase II portion was never initiated. This ...
Detailed Description
This was initially a phase I/II, open-label, non-randomized study using an investigational new drug, TL 32711, in patients with acute myelogenous leukemia. This study targeted subjects 60 years of age...
Eligibility Criteria
Inclusion
- 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:
- Ages 60 or older: Relapsed or refractory after at least one prior therapy for AML
- 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
- Ages 18-59: Relapsed or refractory disease after failing three prior lines of therapy
- 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 transplantation
- Life expectancy of at least 4 weeks
- Must have recovered from toxic effects of prior chemotherapy
- Patients must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing.
- Exclusion criteria
- Cytotoxic chemotherapy (including azacitidine or decitabine) within the past 28 days other than hydroxyurea
- Active participation in any other investigational treatment study for AML.
- ECOG performance status greater than 2
- 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.
- 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.
- Female subjects who are pregnant or breastfeeding
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01486784
Start Date
November 1 2011
End Date
April 1 2015
Last Update
June 24 2021
Active Locations (1)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104