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COMPLETEDPHASE2

Combination of GTI-2040 and Cytarabine in the Treatment of Refractory and Relapsed Acute Myeloid Leukemia (AML)

A Phase II Simon Two-stage Multicenter Study and Pilot Pharmacodynamic Investigation of GTI 2040 in Combination With High Dose Cytarabine (HiDAC) in Refractory and Relapsed Acute Myeloid Leukemia (AML)

NCT00565058•Aptose Biosciences Inc.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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 who require chronic systemic anticoagulant therapy for medical conditions (e.g., previous history of deep venous thrombosis, atrial fibrillation etc.). Heparin administration to maintain central line patency (i.e. catheter flush) is not an exclusion.
+4 more criteria

Locations (7)

San Francisco Veterans Affairs Medical Center

San Francisco, California, United States

UCSF Medical Center

San Francisco, California, United States

Northside Hospital

Atlanta, Georgia, United States

Indiana Cancer Research Institute

Indianapolis, Indiana, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

The Mount Sinai Hospital

New York, New York, United States

The Ohio State University

Columbus, Ohio, United States

Key Dates

Start Date

August 1, 2007

Primary Completion Date

September 1, 2009

Completion Date

February 1, 2010

Last Updated

July 27, 2015

Enrollment

ACTUAL participants

Conditions

Acute Myeloid Leukemia

Interventions

GTI-2040

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 27, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Combination of GTI-2040 and Cytarabine in the Treatment of Refractory and Relapsed Acute Myeloid Leukemia (AML)

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2

Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias