Treatment of Newly Diagnosed Childhood Acute Myeloid Leukemia (AML) Using Intensive MRC-Based Therapy and Gemtuzumab Ozogamicin (GMTZ): A COG Pilot Study

NCT00070174 Phase 2 COMPLETED

RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as gemtuzumab ozogamicin, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying how well gemtuzumab ozogamicin works in treating young patients who are undergoing remission induction, intensification therapy, and allogeneic bone marrow transplant for newly diagnosed acute myeloid leukemia.

Details

Lead sponsor	Children's Oncology Group
Phase	Phase 2
Status	COMPLETED
Enrolment	350
Start date	2003-12
Completion	2013-12

Conditions

• Leukemia

Interventions

• asparaginase
• busulfan
• cyclophosphamide
• cyclosporine
• cytarabine
• daunorubicin hydrochloride
• etoposide
• gemtuzumab ozogamicin
• methotrexate
• mitoxantrone hydrochloride

Primary outcomes

• Safety
• Complete remission rate

Countries

United States, Australia, Canada, Puerto Rico, Switzerland