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

Acute Myeloid Leukemia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Acute Myeloid Leukemia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Gemtuzumab ozogamicinOn Day 6 of an inpatient hospital stay: Based on the study design patients will be treated with one of three doses (3 mg/m^2, 6 mg/m^2 or 9 mg/m^2), administered intravenously in 100 ml of 0.9% sodium chloride over 2 hours.

Drug:MitoxantroneOn Days 1-3 of an inpatient hospital stay: 10 mg/m^2 administered via IVPB (intravenous piggy-back) in 50ml normal saline (NS) over 15 minutes

Drug:EtoposideOn Days 1-5 of an inpatient hospital stay: 100 mg/m^2 administered intravenously in 500 ml of 0.9% sodium chloride over 2 hours

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Gemtuzumab ozogamicin/Mitoxantrone/Etoposide

Study Status

Terminated

Start Date: September 2008

Completed Date: April 2011

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: To evaluate the toxicity and response rate of the combination therapy of mitoxantrone, etoposide and gemtuzumab ozogamicin as second line therapy in patients with acute myeloid leukemia (AML).

Secondary Outcome: To assess the overall survival in patients with AML treated with the combination of mitoxantrone, etoposide and gemtuzumab ozogamicin.

Study sponsors, principal investigator, and references

Principal Investigator: Michael Boyiadzis, MD

Lead Sponsor: University of Pittsburgh

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00660036

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