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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00372593
Registration number
NCT00372593
Ethics application status
Date submitted
6/09/2006
Date registered
7/09/2006
Date last updated
24/03/2021
Titles & IDs
Public title
Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia
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Scientific title
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
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Secondary ID [1]
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COG-AAML0531
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Secondary ID [2]
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AAML0531
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Leukemia
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - asparaginase
Treatment: Drugs - cytarabine
Treatment: Drugs - daunorubicin hydrochloride
Treatment: Drugs - etoposide
Treatment: Drugs - gemtuzumab ozogamicin
Treatment: Drugs - mitoxantrone hydrochloride
Active comparator: Arm A: Standard Arm - No GMTZ, AML Pts w/out Down Syndrome - 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.
Experimental: Arm B: Experimental - with GMTZ, AML Pts w/out Down Syndrome - 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.
Active comparator: Arm A: Standard Arm - No GMTZ, AML Patients with Down Syndrome - 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.
Treatment: Drugs: asparaginase
Given intramuscularly
Treatment: Drugs: cytarabine
Given IV
Treatment: Drugs: daunorubicin hydrochloride
Given IV over 6 hours
Treatment: Drugs: etoposide
Given IV over 1-4 hours
Treatment: Drugs: gemtuzumab ozogamicin
Given IV over 2 hours
Treatment: Drugs: mitoxantrone hydrochloride
Given IV over 1 hour
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Event-free Survival at 3 Years
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Assessment method [1]
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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 a-spending function at\^2 (truncated at 3 standard deviations) and 2.5% type I error.
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Timepoint [1]
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Time from study entry to time of induction failure, relapse, or death, assessed at 3 years
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Primary outcome [2]
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Overall Survival at 3 Years
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Assessment method [2]
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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 a-spending function at\^2 (truncated at 3 standard deviations) and 2.5% type I error.
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Timepoint [2]
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Time from study entry, assessed at 3 years
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Secondary outcome [1]
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Remission Induction Rate After 2 Courses of Induction Therapy
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Assessment method [1]
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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.
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Timepoint [1]
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After 2 courses of induction (I and II) therapy, assessed for up to 10 years
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Secondary outcome [2]
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Disease-free Survival (DFS)
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Assessment method [2]
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Time from end of Intensification I to relapse, death or last contact
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At 3 years from end of Intensification I
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Secondary outcome [3]
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Mortality
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Number of participants who died during the first three courses of therapy.
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During the first three courses of therapy
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Secondary outcome [4]
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Time to Marrow Recovery
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Assessment method [4]
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Mean time to ANC recovery - defined as ANC greater than 500/MicroLiter for 3 consecutive days.
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Timepoint [4]
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At 25 days after treatment with Induction I, Induction II, and Intensification I
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Secondary outcome [5]
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Toxicities, Including Infectious Complications
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Assessment method [5]
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Number of participants with at least one grade 3 or higher adverse event during therapy.
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Timepoint [5]
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From the time therapy is initiated, assessed up to 10 years
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Eligibility
Key inclusion 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
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Minimum age
No limit
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Maximum age
29
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/09/2020
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Sample size
Target
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Accrual to date
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Final
1070
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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Westmead Institute for Cancer Research at Westmead Hospital - Westmead
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Royal Children's Hospital - Herston
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Women's and Children's Hospital - North Adelaide
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Princess Margaret Hospital for Children - Perth
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2145 - Westmead
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4029 - Herston
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5006 - North Adelaide
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6001 - Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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National Cancer Institute (NCI)
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00372593
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Trial related presentations / publications
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. 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. 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. 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. 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. 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. 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.
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Public notes
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Contacts
Principal investigator
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Alan S. Gamis, MD, MPH
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Children's Mercy Hospital Kansas City
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Gamis AS, Alonzo TA, Meshinchi S, Sung L, Gerbing ...
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Results are available at
https://clinicaltrials.gov/study/NCT00372593
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