Spots Global Cancer Trial Database for Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Promyelocytic Leukemia

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Trial Identification

Brief Title: Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Promyelocytic Leukemia

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 ID: NCT01869803

Conditions

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

Interventions

gemtuzumab ozogamicin

laboratory biomarker analysis

Study Description

Brief Summary: This clinical trial studies gemtuzumab ozogamicin in treating patients with relapsed or refractory acute myeloid leukemia or acute promyelocytic leukemia. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.

Detailed Description: PRIMARY OBJECTIVES: 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. OUTLINE: 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.