Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Asparaginase; Busulfan; Cyclophosphamide; Cyclosporine; Cyclosporins; Cytarabine; Daunorubicin; Etoposide; Gemtuzumab; Methotrexate; Mitoxantrone

Criteria

DISEASE CHARACTERISTICS:

• Newly diagnosed primary acute myeloid leukemia (AML)

• At least 20% bone marrow blasts

• Meets the customary FAB criteria for AML

• Patients with cytopenias and bone marrow blasts who do not meet the FAB criteria are eligible provided they have a karyotypic abnormality characteristic of de novo AML (e.g., t[8;21], inv16, or t[16;16]) OR they have the unequivocal presence of megakaryoblasts

• Isolated granulocytic sarcoma (myeloblastoma) allowed regardless of the results outlined above

• Previously untreated disease

• No promyelocytic leukemia (FAB M3)

• No documented myelodysplastic syndromes (preleukemia) (e.g., chronic myelomonocytic leukemia, refractory anemia [RA], RA with excess blasts, or RA with ringed sideroblasts)

• No juvenile myelomonocytic leukemia

• No Fanconi's anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome

• No Down syndrome

PATIENT CHARACTERISTICS:

Age

• 1 month to 21 years* NOTE: *Children under 1 month of age who have progressive disease are allowed

Performance status

• Karnofsky 50-100% (over 16 years of age) OR

• Lansky 50-100% (ages 1 to 16)* NOTE: Children under 1 year of age do not require a performance status

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• No inadequate liver function

Renal

• No inadequate renal function

• No hyperuricemia (greater than 8.0 mg/dL)

• Creatinine clearance or radioisotope glomerular filtration rate (GFR) at least 70 mL/min OR an equivalent normal GFR OR

• Creatinine no greater than 1.5 times normal

Cardiovascular

• Shortening fraction at least 27% by echocardiogram OR

• Ejection fraction at least 50% by MUGA

Pulmonary

• No proven or suspected pneumonia

Other

• Not pregnant or nursing

• No proven or suspected sepsis or meningitis

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy except intrathecal cytarabine administered that was administered at diagnosis

Endocrine therapy

• Prior topical and inhalation steroids allowed

• No concurrent steroids as antiemetics

Radiotherapy

• No prior radiotherapy

Surgery

• Not specified

Other

• No prior antileukemic therapy

• No concurrent pressor agent or ventilatory support unless approved by the study chair

• No concurrent participation in another COG therapeutic study