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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

This study is currently recruiting participants.
Verified April 2013 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01486784
First received: December 5, 2011
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

This is a phase I/II, open-label non-randomized study using an investigational new drug, TL32711, in patients with AML, MDS and ALL. 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 subjects 18-59 (relapsed or refractory after failing 3 prior lines of therapy). This study will also target subjects 18 years of age and older with MDS and ALL.


Condition Intervention Phase
Acute Myelogenous Leukemia
 Drug: TL32711
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: A Phase I-II Open Label Non-Randomized Study Using TL32711 for Patients With Acute Myelogenous Leukemia, Myelodysplastic Syndrome and Acute Lymphoblastic Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Adverse Events [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: Yes ]
    Defined as the time from the first day of therapy to death due to any cause or last patient contact.


Estimated Enrollment: 37
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 1 Drug: TL32711
Experimental: Phase 2 Drug: TL32711

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 AML
    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 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.

    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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486784

Contacts
Contact: Noelle Frey, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Noelle Frey, MD     855-216-0098     PennCancerTrials@emergingmed.com    
Principal Investigator: Noelle Frey, MD            
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01486784     History of Changes
Other Study ID Numbers: UPCC 15411
Study First Received: December 5, 2011
Last Updated: April 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on May 21, 2013