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NCT00372593 · CITED IN SOURCE DOCUMENTS

Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2021-03-24

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

Who could take part
eligibility Criteria
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
healthy Volunteers
false
maximum Age
29 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
    intervention Names
    1. Drug: asparaginase
    2. Drug: cytarabine
    3. Drug: daunorubicin hydrochloride
    4. Drug: etoposide
    5. Drug: mitoxantrone hydrochloride
    label
    Arm A: Standard Arm - No GMTZ, AML Pts w/out Down Syndrome
    type
    ACTIVE_COMPARATOR
  2. description
    Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, \& 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
    intervention Names
    1. Drug: asparaginase
    2. Drug: cytarabine
    3. Drug: daunorubicin hydrochloride
    4. Drug: etoposide
    5. Drug: gemtuzumab ozogamicin
    6. Drug: mitoxantrone hydrochloride
    label
    Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome
    type
    EXPERIMENTAL
  3. description
    Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
    intervention Names
    1. Drug: asparaginase
    2. Drug: cytarabine
    3. Drug: daunorubicin hydrochloride
    4. Drug: etoposide
    5. Drug: mitoxantrone hydrochloride
    label
    Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome
    2. Arm A: Standard Arm - No GMTZ, AML Pts w/out Down Syndrome
    3. Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome
    description
    Given intramuscularly
    name
    asparaginase
    other Names
    1. E.coli
    2. E.coli L-asparaginase
    3. EC 3.5.2.2
    4. colaspase
    5. L-asnase
    6. Elspar
    7. Kidrolase
    8. Crasnitin
    9. Leunase
    10. NSC 109229
    type
    DRUG
  2. arm Group Labels
    1. Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome
    2. Arm A: Standard Arm - No GMTZ, AML Pts w/out Down Syndrome
    3. Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome
    description
    Given IV
    name
    cytarabine
    other Names
    1. Cytosine arabinoside
    2. Ara-C
    3. Cytosar
    4. NSC # 63878
    type
    DRUG
  3. arm Group Labels
    1. Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome
    2. Arm A: Standard Arm - No GMTZ, AML Pts w/out Down Syndrome
    3. Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome
    description
    Given IV over 6 hours
    name
    daunorubicin hydrochloride
    other Names
    1. Daunomycin
    2. rubidomycin
    3. Cerubidine
    4. NSC #82151
    type
    DRUG
  4. arm Group Labels
    1. Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome
    2. Arm A: Standard Arm - No GMTZ, AML Pts w/out Down Syndrome
    3. Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome
    description
    Given IV over 1-4 hours
    name
    etoposide
    other Names
    1. VePesid
    2. Etopophos
    3. VP-16
    4. NSC #141540
    type
    DRUG
  5. arm Group Labels
    1. Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome
    description
    Given IV over 2 hours
    name
    gemtuzumab ozogamicin
    other Names
    1. Mylotarg
    2. GMTZ
    type
    DRUG
  6. arm Group Labels
    1. Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome
    2. Arm A: Standard Arm - No GMTZ, AML Pts w/out Down Syndrome
    3. Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome
    description
    Given IV over 1 hour
    name
    mitoxantrone hydrochloride
    other Names
    1. Novantrone
    2. CL 232315
    3. DAD
    4. DHAD
    5. Mitozantrone
    6. NSC #301739
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1070
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The Kaplan-Meier method will be used to calculate estimates of Event Free Survival (EFS). The log-rank test will be used to compare survival between treatment groups. Analysis of EFS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to Overall Survival (OS) and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt\^2 (truncated at 3 standard deviations) and 2.5% type I error.
    measure
    Event-free Survival at 3 Years
    time Frame
    Time from study entry to time of induction failure, relapse, or death, assessed at 3 years
  2. description
    The Kaplan-Meier method will be used to calculate estimates of OS. Analysis of OS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to OS and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt\^2 (truncated at 3 standard deviations) and 2.5% type I error.
    measure
    Overall Survival at 3 Years
    time Frame
    Time from study entry, assessed at 3 years
secondary Outcomes
  1. description
    Patients without an evaluable bone marrow at the end of Induction I will be excluded from the calculation of remission rate after 2 courses of therapy because their responses are not evaluable. The following patients will be considered to not be in complete remission (CR) after 2 courses of therapy: (1) patients who die during Induction I and II; (2) patients with ≥ 5% blasts or extramedullary disease at the end of Induction II.
    measure
    Remission Induction Rate After 2 Courses of Induction Therapy
    time Frame
    After 2 courses of induction (I and II) therapy, assessed for up to 10 years
  2. description
    Time from end of Intensification I to relapse, death or last contact
    measure
    Disease-free Survival (DFS)
    time Frame
    At 3 years from end of Intensification I
  3. description
    Number of participants who died during the first three courses of therapy.
    measure
    Mortality
    time Frame
    During the first three courses of therapy
  4. description
    Mean time to ANC recovery - defined as ANC greater than 500/MicroLiter for 3 consecutive days.
    measure
    Time to Marrow Recovery
    time Frame
    At 25 days after treatment with Induction I, Induction II, and Intensification I
  5. description
    Number of participants with at least one grade 3 or higher adverse event during therapy.
    measure
    Toxicities, Including Infectious Complications
    time Frame
    From the time therapy is initiated, assessed up to 10 years
Full study description
brief Summary
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.
detailed Description
OBJECTIVES: Primary * Compare the event-free survival (EFS) and overall survival (OS) of young patients with newly diagnosed acute myeloid leukemia (AML) treated with conventional combination chemotherapy with vs without gemtuzumab ozogamicin (GMTZ). Secondary * Compare the remission induction rates after two courses of therapy in these patients. * Compare disease-free survival and OS in patients who are eligible for an human leukocyte antigen (HLA)-matched family donor (MFD) stem cell transplant (SCT) by virtue of their risk classification, with patients assigned to MFD SCT if a MFD is available, or to chemotherapy if a MFD is not available. * Determine the outcome of patients with Down syndrome who are 4 years of age or older at diagnosis and treated with conventional combination chemotherapy without GMTZ. * Compare the EFS and OS of patients with de novo AML treated with conventional combination chemotherapy with vs without GMTZ censoring MFD SCT recipients. * Determine the prevalence and prognostic significance of molecular abnormalities of KIT, CCAAT-enhancer binding protein alpha (CEBPα) and MLL-Partial tandem duplications (PTD) genes in these patients. * Determine the leukemic involvement of hematopoietic early progenitor and its role in defining response to therapy. * Assess the ability of a second-generation flow cytometric assay to predict patients at high risk for relapse during periods of clinical remission. * Examine whether GMTZ significantly improves EFS and OS in patients with higher CD33 concentrations/intensity. * Examine whether GMTZ significantly improves complete remission, EFS, and OS in each of the cytogenetic risk groups (high-, intermediate-, and low-risk) identified in prior Medical Research Council trials. * Utilize fluorescence in situ hybridization (FISH) analysis to identify variant patterns among subgroups of patients who demonstrate the same G-banded chromosomal abnormality (e.g., inv\[16\]/t\[16;16\], t\[8;21\], 11q23 abnormality) and determine whether these variant patterns account for the heterogeneity of responses to therapy. * Examine the impact of complex karyotypes (≥ 3, ≥ 4, and ≥ 5 abnormalities) on OS and EFS in intermediate-risk patients for whom no high-risk or low-risk cytogenetic abnormalities exist. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to relapse risk (high vs intermediate vs low). Patients are randomized to 1 of 2 treatment arms. Patients with Down syndrome are nonrandomly assigned to arm I (but do not undergo allogeneic stem cell transplant \[SCT\]). * Arm I (standard therapy): * Induction 1: Patients receive cytarabine IT at the time of diagnosis or on day 1\*. Patients also receive cytarabine IV on days 1-10, daunorubicin hydrochloride IV over 6 hours on days 1, 3, and 5, and etoposide IV over 4 hours on days 1-5. After 3 weeks of rest, all patients (regardless of remission status) proceed to induction 2. NOTE: \*Patients with Central Nervous System (CNS) disease receive cytarabine IT twice weekly until the cerebrospinal fluid is clear, followed by two additional IT treatments. Patients with refractory CNS leukemia after 6 doses of IT treatment are removed from the study. * Induction 2: Patients receive cytarabine IT on day 1, cytarabine IV on days 1-8, daunorubicin hydrochloride IV over 6 hours on days 1, 3, and 5, and etoposide IV over 4 hours on days 1-5. After 3 weeks of rest, patients in complete remission (CR) proceed to intensification 1. Patients with refractory disease are removed from protocol therapy. * Intensification 1: Patients receive cytarabine IT on day 1, high-dose cytarabine IV over 1 hour on days 1-5, and etoposide IV over 1 hour on days 1-5. After 3 weeks of rest, patients in remission proceed to intensification 2, followed by intensification 3. Patients in remission proceed to allogeneic SCT 2-8 weeks after blood counts recover. Patients with high-risk disease with an alternative donor proceed to intensification 2 and 3, followed by allogeneic SCT. Patients not in remission are removed from protocol therapy. * Intensification 2: Patients receive cytarabine IT on day 1, high-dose cytarabine IV over 2 hours on days 1-4, and mitoxantrone hydrochloride IV over 1 hour on days 3-6. After 3 weeks of rest, patients proceed to intensification 3. * Intensification 3: Patients receive high-dose cytarabine IV over 3 hours on days 1, 2, 8, and 9 and asparaginase intramuscularly on days 2 and 9. * Arm II: * Induction 1: Patients receive treatment as in induction 1 of arm I. Patients also receive gemtuzumab ozogamicin (GMTZ) IV over 2 hours on day 6. * Induction 2: Patients receive treatment as in induction 2 of arm I. * Intensification 1: Patients receive treatment as in intensification 1 of arm I. * Intensification 2: Patients receive treatment as in intensification 2 of arm I. Patients also receive GMTZ IV over 2 hours on day 7. * Intensification 3: Patients receive treatment as in intensification 3 of arm I. * Allogeneic SCT (for patients with intermediate- or high-risk disease): * MFD: Patients receive a conditioning regimen comprising busulfan IV over 2 hours every 6 hours on days -9 to -6 and cyclophosphamide IV over 1 hour on days -5 to -2. Patients undergo allogeneic SCT on day 0. Patients receive cyclosporine IV or orally twice daily on days -1 to 180 and methotrexate IV on days 1, 3, 6, and 11. Patients receive graft-vs-host disease (GVHD) prophylaxis comprising cyclosporine IV over 1-4 hours or orally twice daily on days -1 to 180 and methotrexate IV on days 1, 3, 6, and 11. * Matched alternative donor: Patients receive a conditioning regimen comprising busulfan and cyclophosphamide as above. Patients also receive antithymocyte globulin IV over 6-8 hours on days -3 to -1. Patients then undergo allogeneic SCT and receive GVHD prophylaxis as above. After completion of study treatment, patients are followed periodically for 3 years and then annually thereafter. PROJECTED ACCRUAL: A total of 1,012 patients will be accrued for this study.
Source references
references
  1. citation
    Pollard JA, Alonzo TA, Loken M, Gerbing RB, Ho PA, Bernstein ID, Raimondi SC, Hirsch B, Franklin J, Walter RB, Gamis A, Meshinchi S. Correlation of CD33 expression level with disease characteristics and response to gemtuzumab ozogamicin containing chemotherapy in childhood AML. Blood. 2012 Apr 19;119(16):3705-11. doi: 10.1182/blood-2011-12-398370. Epub 2012 Feb 29.
    pmid
    22378848
    type
    BACKGROUND
  2. citation
    Gamis AS, Alonzo TA, Meshinchi S, Sung L, Gerbing RB, Raimondi SC, Hirsch BA, Kahwash SB, Heerema-McKenney A, Winter L, Glick K, Davies SM, Byron P, Smith FO, Aplenc R. Gemtuzumab ozogamicin in children and adolescents with de novo acute myeloid leukemia improves event-free survival by reducing relapse risk: results from the randomized phase III Children's Oncology Group trial AAML0531. J Clin Oncol. 2014 Sep 20;32(27):3021-32. doi: 10.1200/JCO.2014.55.3628.
    pmid
    25092781
    type
    RESULT
  3. citation
    Scheidegger N, Schneider C, Alexe G, Wang YC, Alonzo TA, Basanthakumar A, Bourgeois WA, Dudkiewicz-Garbicz J, Khalid D, Merickel LA, Perry JA, Ries RE, Salhotra S, Taillon A, Gamis A, Aplenc R, Harris MH, Wunderlich M, Armstrong SA, Pollard JA, Meshinchi S, Pikman Y, Stegmaier K. Combining menin and MEK inhibition to target poor prognosis KMT2A-rearranged RAS pathway-mutant acute myeloid leukemia. Blood Adv. 2026 Jul 14;10(13):4757-4771. doi: 10.1182/bloodadvances.2025016208.
    pmid
    42085603
    type
    DERIVED
  4. citation
    Huang BJ, Meyer LK, Alonzo TA, Wang YC, Lamble AJ, Ries RE, Wang W, Hirsch B, Raca G, Ma X, Gamis AS, Aplenc R, Kolb EA, Cooper TM, Tarlock K, Loken MR, Meshinchi S, Chewning JH, Woods WG, Horan JT. Hematopoietic Stem Cell Transplantation Outcomes for High-Risk AML: A Report From the Children's Oncology Group. J Clin Oncol. 2025 Jun 10;43(17):1961-1971. doi: 10.1200/JCO-24-01841. Epub 2025 Apr 28.
    pmid
    40294366
    type
    DERIVED
  5. citation
    Tarlock K, Gerbing RB, Ries RE, Smith JL, Leonti A, Huang BJ, Kirkey D, Robinson L, Peplinski JH, Lange B, Cooper TM, Gamis AS, Kolb EA, Aplenc R, Pollard JA, Alonzo TA, Meshinchi S. Prognostic impact of cooccurring mutations in FLT3-ITD pediatric acute myeloid leukemia. Blood Adv. 2024 May 14;8(9):2094-2103. doi: 10.1182/bloodadvances.2023011980.
    pmid
    38295280
    type
    DERIVED
  6. citation
    Zarnegar-Lumley S, Alonzo TA, Gerbing RB, Othus M, Sun Z, Ries RE, Wang J, Leonti A, Kutny MA, Ostronoff F, Radich JP, Appelbaum FR, Pogosova-Agadjanyan EL, O'Dwyer K, Tallman MS, Litzow M, Atallah E, Cooper TM, Aplenc RA, Abdel-Wahab O, Gamis AS, Luger S, Erba H, Levine R, Kolb EA, Stirewalt DL, Meshinchi S, Tarlock K. Characteristics and prognostic impact of IDH mutations in AML: a COG, SWOG, and ECOG analysis. Blood Adv. 2023 Oct 10;7(19):5941-5953. doi: 10.1182/bloodadvances.2022008282.
    pmid
    37267439
    type
    DERIVED
  7. citation
    Bertrums EJM, Smith JL, Harmon L, Ries RE, Wang YJ, Alonzo TA, Menssen AJ, Chisholm KM, Leonti AR, Tarlock K, Ostronoff F, Pogosova-Agadjanyan EL, Kaspers GJL, Hasle H, Dworzak M, Walter C, Muhlegger N, Morerio C, Pardo L, Hirsch B, Raimondi S, Cooper TM, Aplenc R, Gamis AS, Kolb EA, Farrar JE, Stirewalt D, Ma X, Shaw TI, Furlan SN, Brodersen LE, Loken MR, Van den Heuvel-Eibrink MM, Zwaan CM, Triche TJ, Goemans BF, Meshinchi S. Comprehensive molecular and clinical characterization of NUP98 fusions in pediatric acute myeloid leukemia. Haematologica. 2023 Aug 1;108(8):2044-2058. doi: 10.3324/haematol.2022.281653.
    pmid
    36815378
    type
    DERIVED
  8. citation
    Elgarten CW, Wood AC, Li Y, Alonzo TA, Brodersen LE, Gerbing RB, Getz KD, Huang YV, Loken M, Meshinchi S, Pollard JA, Sung L, Woods WG, Kolb EA, Gamis AS, Aplenc R. Outcomes of intensification of induction chemotherapy for children with high-risk acute myeloid leukemia: A report from the Children's Oncology Group. Pediatr Blood Cancer. 2021 Dec;68(12):e29281. doi: 10.1002/pbc.29281. Epub 2021 Oct 1.
    pmid
    34596937
    type
    DERIVED
  9. citation
    Brodersen LE, Gerbing RB, Pardo ML, Alonzo TA, Paine D, Fritschle W, Hsu FC, Pollard JA, Aplenc R, Kahwash SB, Hirsch B, Ramondi S, Wells D, Kolb EA, Gamis AS, Meshinchi S, Loken MR. Morphologic remission status is limited compared to DeltaN flow cytometry: a Children's Oncology Group AAML0531 report. Blood Adv. 2020 Oct 27;4(20):5050-5061. doi: 10.1182/bloodadvances.2020002070.
    pmid
    33080007
    type
    DERIVED
  10. citation
    Voigt AP, Brodersen LE, Alonzo TA, Gerbing RB, Menssen AJ, Wilson ER, Kahwash S, Raimondi SC, Hirsch BA, Gamis AS, Meshinchi S, Wells DA, Loken MR. Phenotype in combination with genotype improves outcome prediction in acute myeloid leukemia: a report from Children's Oncology Group protocol AAML0531. Haematologica. 2017 Dec;102(12):2058-2068. doi: 10.3324/haematol.2017.169029. Epub 2017 Sep 7.
    pmid
    28883080
    type
    DERIVED
  11. citation
    Eidenschink Brodersen L, Alonzo TA, Menssen AJ, Gerbing RB, Pardo L, Voigt AP, Kahwash SB, Hirsch B, Raimondi S, Gamis AS, Meshinchi S, Loken MR. A recurrent immunophenotype at diagnosis independently identifies high-risk pediatric acute myeloid leukemia: a report from Children's Oncology Group. Leukemia. 2016 Oct;30(10):2077-2080. doi: 10.1038/leu.2016.119. Epub 2016 May 2. No abstract available.
    pmid
    27133823
    type
    DERIVED
  12. citation
    Sung L, Aplenc R, Alonzo TA, Gerbing RB, Lehrnbecher T, Gamis AS. Effectiveness of supportive care measures to reduce infections in pediatric AML: a report from the Children's Oncology Group. Blood. 2013 May 2;121(18):3573-7. doi: 10.1182/blood-2013-01-476614. Epub 2013 Mar 7.
    pmid
    23471307
    type
    DERIVED
see Also Links
  1. label
    Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-3fdaf92990371ac6dabb
      requested nct id
      NCT00372593
      primary nct id
      NCT00372593
      source kind
      fda_spl_label
      source url
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        supported by evidence of effectiveness from adequate and well-controlled studies in adults with supportive data on safety and effectiveness in Study AAML0531 (NCT00372593) [see Adverse Reactions (6.1) , Clinical Studies (14.1) ]. AAML0531 included patients in the following age groups: 2 patients less than 27 days old, 94 patient
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        a).</li></ul></div><p id="_1943" tabindex="-1">COG trials (including <a href="/clinicaltrials/NCT00070174">AAML03P1 [NCT00070174]</a>, <a href="/clinicaltrials/NCT00372593">AAML0531 [NCT00372593]</a>, and <a href="/clinicaltrials/NCT01371981">AAML1031 [NCT01371981]</a>) used a modified version of the CNS disease definitions, in w
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        d="_1943" tabindex="-1">COG trials (including <a href="/clinicaltrials/NCT00070174">AAML03P1 [NCT00070174]</a>, <a href="/clinicaltrials/NCT00372593">AAML0531 [NCT00372593]</a>, and <a href="/clinicaltrials/NCT01371981">AAML1031 [NCT01371981]</a>) used a modified version of the CNS disease definitions, in which patients were dich
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        s that differ from the pattern observed in normal progenitors.</p><div class="pdq-content-list"><ul id="_2136"><li> In a COG analysis (<a href="/clinicaltrials/NCT00372593">AAML0531 [NCT00372593]</a>) of 784 patients, the following results were reported:[<a href="#cit/section_4.72">72</a>]<div class="pdq-content-list"><ul id="_21
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        pattern observed in normal progenitors.</p><div class="pdq-content-list"><ul id="_2136"><li> In a COG analysis (<a href="/clinicaltrials/NCT00372593">AAML0531 [NCT00372593]</a>) of 784 patients, the following results were reported:[<a href="#cit/section_4.72">72</a>]<div class="pdq-content-list"><ul id="_2137"><li> Sixty-nine per
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        have used a risk classification system to stratify treatment choices:</p> <div class="pdq-content-list"><ol id="_896"><li>In COG <a href="/clinicaltrials/NCT00372593">AAML0531 (NCT00372593)</a>, the first COG trial to stratify therapy by risk group, patients were stratified into three risk groups on the basis of diagnostic
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        fication system to stratify treatment choices:</p> <div class="pdq-content-list"><ol id="_896"><li>In COG <a href="/clinicaltrials/NCT00372593">AAML0531 (NCT00372593)</a>, the first COG trial to stratify therapy by risk group, patients were stratified into three risk groups on the basis of diagnostic cytogenetics and respo
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        high-risk AML.[<a href="#cit/section_6.14">14</a>]<div class="pdq-content-list"><ul id="_2081"><li> In a planned comparison with the <a href="/clinicaltrials/NCT00372593">AAML0531 (NCT00372593)</a> trial, which used a standard ADE regimen in the second induction cycle for similar patients, neither response nor survival was impr
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        s Oncology Group (COG) completed two trials&#8212;<a href="/clinicaltrials/NCT00070174">AAML03P1 (NCT00070174)</a>, a pilot study, and <a href="/clinicaltrials/NCT00372593">AAML0531 (NCT00372593)</a>, a randomized trial&#8212;that examined the incorporation of gemtuzumab ozogamicin into induction therapy.[<a href="#cit/section_6.
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        exact text
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        exact text
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      11. context exact
        equent study confirmed the results of the SJCRH study.[<a href="#cit/section_6.36">36</a>]</li><li>A retrospective report from the COG <a href="/clinicaltrials/NCT00372593">AAML0531 (NCT00372593)</a> trial demonstrated the following results:[<a href="#cit/section_6.37">37</a>]<div class="pdq-content-list"><ul id="_2005"><li>Ther
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        exact text
        NCT00372593
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      12. context exact
        the results of the SJCRH study.[<a href="#cit/section_6.36">36</a>]</li><li>A retrospective report from the COG <a href="/clinicaltrials/NCT00372593">AAML0531 (NCT00372593)</a> trial demonstrated the following results:[<a href="#cit/section_6.37">37</a>]<div class="pdq-content-list"><ul id="_2005"><li>There were significant redu
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        datetime
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        display
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      payload sha256
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      source url
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    Preserved source evidence · Not medical advice