Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Promyelocytic Leukemia
|ClinicalTrials.gov Identifier: NCT01869803|
Recruitment Status : Suspended
First Posted : June 5, 2013
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|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) Childhood Acute Promyelocytic Leukemia (M3) Recurrent Adult Acute Myeloid Leukemia Recurrent Childhood Acute Myeloid Leukemia||Drug: gemtuzumab ozogamicin Other: laboratory biomarker analysis||Phase 2|
I. To provide patients with acute myeloid leukemia (AML) or acute promyelocytic leukemia (APL), who have relapsed or who are refractory to standard treatments, with access to gemtuzumab ozogamicin (Mylotarg) when no other comparable or satisfactory alternative therapy is available.
II. To carefully monitor safety and to report safety information from patients receiving Mylotarg in this setting.
Patients receive gemtuzumab ozogamicin intravenously (IV) over 2 hours on days 1 and 15.
After completion of study treatment, patients are followed up every month for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Compassionate Use of Gemtuzumab Ozogamicin (Mylotarg) for Treatment of Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia (AML) or Acute Promyelocytic Leukemia (APL)|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: Treatment (gemtuzumab ozogamicin)
Patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15.
Drug: gemtuzumab ozogamicin
Other Names:Other: laboratory biomarker analysis
- Access to gemtuzumab ozogamicin [ Time Frame: Up to 1 year ]
- Incidence of adverse events as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869803
|United States, North Carolina|
|Comprehensive Cancer Center of Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Leslie Ellis||Wake Forest University Health Sciences|