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

• Status: Terminated
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Treatments: Etoposide; Etoposide phosphate; Gemtuzumab; Mitoxantrone

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.