- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01548911
Gemtuzumab Ozogamicin in Treating Patients With Acute Myeloid Leukemia
Safety and Efficacy of Gemtuzumab Ozogamicin (Mylotarg®) as for Treatment of Patients With CD33-Positive Acute Myeloid Leukemia (AML)
Study Overview
Status
Conditions
- Recurrent Adult 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(16;16)(p13;q22)
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Adult Acute Promyelocytic Leukemia (M3)
- Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
OUTLINE:
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.
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must have confirmed relapsed or refractory acute myeloid leukemia and not a candidate for standard induction treatment after daunorubicin and cytosine arabinoside OR acute promyelocytic leukemia relapsed after all-trans retinoic acid (ATRA) or Arsenic trioxide therapy
- Patients must have an initial diagnosis of acute myeloid leukemia or biphenotypic acute leukemia
- Patients must have CD33 positivity of >= 30%
- Eastern Cooperative Oncology Group (ECOG) performance status =< 3
- Karnofsky > 60%
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2 X institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance >= 30 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- The effects of Mylotarg on the developing human fetus are unknown; for this reason and because Mylotarg class agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients may not be receiving any other investigational agents for leukemia
- Patients with known untreated Hepatitis C because veno-occlusive disease and liver enzyme abnormalities have been associated with Mylotarg
- Uncontrolled intercurrent illness including, but not limited to active liver disease, ongoing or active sepsis requiring vasopressors or mechanical ventilation, symptomatic congestive heart failure, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study because Mylotarg is a Class D agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Mylotarg, breastfeeding should be discontinued if the mother is treated with Mylotarg
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Mylotarg; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
- Congestive Heart Failure (CHF) with an ejection fraction < 30%
- Glomerular filtration rate (GFR) < 30ml/min
- Active central nervous system (CNS) involvement of leukemia
- Philadelphia chromosome + acute lymphoblastic leukemia (ALL)
- Prior hematopoietic transplant in last 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Correlative studies
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Approximately 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response, defined as complete remission (CR) and CR with incomplete platelet recovery (CRp)
Time Frame: At 28 days
|
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
|
Approximately 1 year
|
Overall survival (OS)
Time Frame: Approximately 1 year
|
Approximately 1 year
|
|
Event-free survival (EFS)
Time Frame: Approximately 1 year
|
Approximately 1 year
|
|
Disease free survival (DFS)
Time Frame: Approximately 1 year
|
Approximately 1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Leslie Ellis, MD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00019491
- NCI-2012-00127 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CCCWFU 22311 (Other Identifier: Wake Forest University Health Sciences)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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