Gemtuzumab Ozogamicin in Treating Patients With Acute Myeloid Leukemia
|Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Acute Promyelocytic Leukemia (M3) Recurrent Adult Acute Myeloid Leukemia||Drug: gemtuzumab ozogamicin Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy of Gemtuzumab Ozogamicin (Mylotarg®) as for Treatment of Patients With CD33-Positive Acute Myeloid Leukemia (AML)|
- Rate of serious adverse events [ Time Frame: Approximately 1 year ]95% confidence interval will be calculated. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Overall response, defined as complete remission (CR) and CR with incomplete platelet recovery (CRp) [ Time Frame: At 28 days ]
- Safety analysis of gemtuzumab ozogamicin as induction therapy for patients with relapsed AML [ Time Frame: Approximately 1 year ]Adverse event frequency and severity
- Overall survival (OS) [ Time Frame: Approximately 1 year ]
- Event-free survival (EFS) [ Time Frame: Approximately 1 year ]
- Disease free survival (DFS) [ Time Frame: Approximately 1 year ]
|Study Start Date:||May 2012|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (monoclonal antibody therapy)
Patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity.
Drug: gemtuzumab ozogamicin
Other Names:Other: laboratory biomarker analysis
I. To study safety and efficacy single agent Gemtuzumab Ozogamicin (Mylotarg®) as induction therapy for patients with Acute Myeloid Leukemia (AML) who have relapsed after standard treatments or who are not candidates for standard consolidation treatment after Daunorubicin and cytosine arabinoside.
I. To correlate morbidity and mortality with the use of gemtuzumab (gemtuzumab ozogamicin) to specific subtypes of leukemia.
II. To correlate gemtuzumab response to degree of cluster of differentiation (CD) 33 positivity.
III. To correlate FMS-Related Tyrosine Kinase 3 (FLT 3)/nucleophosmin (NPM) status and CD 33 positivity to gemtuzumab response.
IV. To document incidence of sinusoidal obstruction syndrome with the use of gemtuzumab.
Patients receive gemtuzumab ozogamicin intravenously (IV) over 2 hours on days 1 and 15. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up monthly for 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548911
|Principal Investigator:||Leslie Ellis, MD||Wake Forest University Health Sciences|