NCT00565058

Brief Summary

This is a Phase II trial conducted at multiple centers for evaluation of the pharmacodynamic activity and the overall response rate contributed by the combination agents of GTI-2040 and High Dose Cytarabine (HiDAC) in Refractory and Relapsed Acute Myeloid Leukemia (AML).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

July 27, 2015

Completed
Last Updated

July 27, 2015

Status Verified

April 1, 2015

Enrollment Period

2.1 years

First QC Date

November 27, 2007

Results QC Date

June 29, 2015

Last Update Submit

June 29, 2015

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate of GTI-2040 Combined With HiDAC in Refractory or Relapsed AML

    Overall Response was defined as whether or not the patient achieved complete remission (CR) and CR with incomplete blood count recovery (CRi) while on the study.

    at 29-35 days

Secondary Outcomes (1)

  • Summary of Treatment Emergent Adverse Events

    30 days after the last dose

Study Arms (2)

Pilot

EXPERIMENTAL

Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.

Biological: GTI-2040

Phase II arm

EXPERIMENTAL

Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.

Biological: GTI-2040

Interventions

GTI-2040BIOLOGICAL

GTI-2040 will be administered one day after HiDAC in the pilot PD study and one day before HiDAC in the Phase II study for a cycle. Those who achieve a complete remission (CR) will be permitted to receive one cycle of consolidation of GTI-2040 and HiDAC

Phase II armPilot

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients must have unequivocal histologic diagnosis of AML according to WHO classification.
  • Patients must have (1) refractory AML, defined as a disease unresponsive to the initial treatment; or (2) relapsed AML, defined as disease that re-occurs after treatment with conventional or high dose chemotherapy, with or without autologous stem cell support.
  • Patients previously treated with antisense oligonucleotides remain eligible in absence of significant or dose-limiting documented toxicities directly attributable to the antisense agents.
  • Age 18-59 years old.
  • Because no dosing or adverse event data are currently available on the use of GTI-2040 in combination with cytarabine in patients \<18 years of age, children are excluded from this study but will be eligible for future pediatric Phase 2 combination trials.
  • Eastern Cooperative Oncology Group (ECOG) performance status \<= 2 (Karnofsky \>60%).
  • Patients with central nervous system (CNS) involvement will be considered eligible for this study if no residual leukemic cells are detectable in the cerebral spinal fluid following intrathecal or radiation therapy.
  • Central line catheter for administration of GTI-2040 infusion is required for all patients enrolled in the study.
  • Ability to understand and the willingness to sign a written informed consent document. Written informed consent is required prior to any study procedures for screening or enrollment.

You may not qualify if:

  • Patients who have had chemotherapy (with the exception of hydroxyurea) or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Patients who have received mitomycin C or nitrosurea require a 6 week recovery period before enrollment.
  • Patients who have had prior allogeneic stem cell transplant.
  • Patients may not be receiving any other investigational agents as part of ongoing treatment.
  • Patients with the following abnormal clinical values (unless abnormalities in these parameters are directly attributable to malignancy):
  • Resting cardiac ejection fraction \< 50%
  • Serum creatinine \> 1.5 mg/dL
  • Total bilirubin \> 2x upper limits of normal (ULN) (unless due to Gilbert's syndrome)
  • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 3x ULN
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to GTI-2040 or other agents used in the study.
  • Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
  • Serious medical or psychiatric illness that would prevent informed consent or limit survival to \< 4 weeks.
  • Pregnancy or breastfeeding women. The potential for teratogenic effects and other risks for GTI-2040 in nursing infants are unknown. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.
  • HIV-positive patients on combination antiretroviral therapy are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

UCSF Medical Center

San Francisco, California, 94121, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Indiana Cancer Research Institute

Indianapolis, Indiana, 46202, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

The Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

GTI2040

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title
Peter Murray, Director Clinical Development
Organization
Aptose Biosciences Inc.
pmurray@aptose.com
647-479-9812

Study Officials

  • Rebecca B Klisovic, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2007

First Posted

November 29, 2007

Study Start

August 1, 2007

Primary Completion

September 1, 2009

Study Completion

February 1, 2010

Last Updated

July 27, 2015

Results First Posted

July 27, 2015

Record last verified: 2015-04

Locations

US(7)