NCT00372593
Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia
PHASE3
COMPLETED
NCT00372593
INTERVENTIONAL
A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg) Combined With Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving combination chemotherapy together with gemtuzumab may kill more cancer cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab in treating patients with newly diagnosed acute myeloid leukemia.
PURPOSE: This randomized phase III trial is studying combination chemotherapy and gemtuzumab to see how well they work compared with combination chemotherapy alone in treating young patients with newly diagnosed acute myeloid leukemia.
DISEASE CHARACTERISTICS:
* Newly diagnosed acute myeloid leukemia (AML)
* Meets customary criteria for AML with ≥ 20% bone marrow blasts (by WHO classification)
* Patients with \< 20% bone marrow blasts and cytopenia or myelodysplastic syndromes (e.g., chronic myelomonocytic leukemia, refractory anemia (RA), RA with excess blasts, RA with ringed sideroblasts) are eligible provided 1 of the following criteria is met:
* Karyotypic abnormality characteristic of de novo AML (t\[8;21\]\[q22;q22\], inv\[16\]\[p13q22\], t\[16;16\]\[p13;q22\], or 11q23 abnormalities)
* Unequivocal presence of megakaryoblasts (by WHO classification)
* Isolated myeloid sarcoma (i.e., myeloblastoma or chloroma) allowed regardless of bone marrow results
* Infants \< 1 month of age with progressive disease\* are eligible NOTE: \*Infants \< 1 month of age with AML may be given supportive care until it is clear that the leukemia is not regressing (i.e., the disappearance of peripheral blasts and the normalization of peripheral blood counts)
* Patients with Down syndrome ≥ 4 years of age are eligible
* No juvenile myelomonocytic leukemia
* No Fanconi's anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome
* No promyelocytic leukemia (M3)
* No secondary or treatment-related AML
* Matched family donor criteria (for patients with intermediate-risk or high-risk disease):
* HLA-A, -B, -C, and beta chain (-DRB1), identical or 1 antigen or allele mismatched by molecular high resolution technique
* All available first-degree family members (parents and siblings) must be HLA typed
* No syngeneic donors
* Matched alternative donor criteria (for patients with high-risk disease):
* HLA-A, -B, -C, and -DRB1, identical or 1 antigen or allele mismatched donor
* HLA-A, -B, and -DRB1 4 of 6 antigen matched unrelated cord blood donor
* Mismatched family member donor with ≥ 1 haplotype match or 5 of 6 antigen phenotypic match
PATIENT CHARACTERISTICS:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy, radiation therapy, or any antileukemic therapy
* Topical or inhalation steroids for other conditions allowed
* Intrathecal cytarabine given at diagnosis allowed
* No other prior treatment for AML
* No concurrent peripheral blood stem cell transplantation in patients with matched family donor
Leukemia
- TREATMENT
-
- Type: DRUG
- Name: asparaginase
- Description: Given intramuscularly
- Arm Group Labels: Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome, Arm A: Standard Arm - No GMTZ, AML Pts w/out Down Syndrome, Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome
-
- Type: DRUG
- Name: cytarabine
- Description: Given IV
- Arm Group Labels: Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome, Arm A: Standard Arm - No GMTZ, AML Pts w/out Down Syndrome, Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome
-
- Type: DRUG
- Name: daunorubicin hydrochloride
- Description: Given IV over 6 hours
- Arm Group Labels: Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome, Arm A: Standard Arm - No GMTZ, AML Pts w/out Down Syndrome, Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome
-
- Type: DRUG
- Name: etoposide
- Description: Given IV over 1-4 hours
- Arm Group Labels: Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome, Arm A: Standard Arm - No GMTZ, AML Pts w/out Down Syndrome, Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome
-
- Type: DRUG
- Name: gemtuzumab ozogamicin
- Description: Given IV over 2 hours
- Arm Group Labels: Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome
-
- Type: DRUG
- Name: mitoxantrone hydrochloride
- Description: Given IV over 1 hour
- Arm Group Labels: Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome, Arm A: Standard Arm - No GMTZ, AML Pts w/out Down Syndrome, Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome
- Children's Oncology Group