Phase I/II Study of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin for Acute Myeloid Leukemia

Stopped early · Phase 1

Conditions studied: Acute Myeloid Leukemia

In brief

The purpose of this study is to investigate the combination of gemtuzumab ozogamicin, mitoxantrone and etoposide as second line therapy in patients with acute myeloid leukemia.

Key facts

Study ID

NCT00660036

Run by

University of Pittsburgh

People needed

5

Starts

2008-09-01

Expected to finish

2011-04-01

Last updated by the study team

2016-01-15

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to understand and have the ability to provide written consent
• Between 18 and 70 years of age
• Patients with CD33 positive (determined as CD33 expression in ≥ 20% of leukemic blasts) de novo AML that did not respond to first line induction therapy
• ECOG Performance Status of 0-2
• Patients must have the following laboratory values within 48 hours prior to beginning protocol treatment: Serum creatinine ≤ 1.5 mg/ml and calculated creatinine clearance ≥ 50mL/min (using the Cockcroft-Gault equation); AST ≤ 59 IU/L; ALT ≤ 72 IU/L; Total bilirubin ≤ 1.3 mg/ml; Note: Hematologic abnormalities will not be used as a criteria for entry or exclusion.
• Patients must have left ventricular ejection fraction (LVEF) ≥50%
• Females of child-bearing potential must have a negative pregnancy test during screening and all subjects must agree to use an effective method of contraception.

You may not qualify if…

• Patients with acute promyelocytic leukemia
• Prior use of mitoxantrone or etoposide or gemtuzumab ozogamicin
• Antecedent hematologic disorder preceding initial presentation of AML or therapy related AML
• History of thromboembolic event within the past 12 months
• Hepatitis B or C or HIV positive serology
• Symptomatic central nervous system (CNS) involvement
• History of congestive heart failure
• Myocardial infarction in the past 6 months
• Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy
• History of psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent
• Patient may not be receiving any other anti neoplastic investigational agents
• INR> 1.5 or patient is receiving systemic anticoagulation (e.g warfarin)
• Patient undergone autologous or allogeneic stem cell transplantation
• Other active malignancies except for non-melanoma skin cancer or cervical intraepithelial neoplasia
• Women who are pregnant or breastfeeding.

Where it is running

• University of Pittsburgh Cancer Institute / Hillman Cancer Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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