Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Promyelocytic Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01869803|
Expanded Access Status : Approved for marketing (FDA approved study drug)
First Posted : June 5, 2013
Last Update Posted : March 2, 2018
|Condition or disease||Intervention/treatment|
|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|
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 :||Expanded Access|
|Expanded Access Type :||Intermediate-size Population|
|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)|
- Drug: gemtuzumab ozogamicin
Given IVOther Names:
- Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody
- Other: laboratory biomarker analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|