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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00103285
Registration number
NCT00103285
Ethics application status
Date submitted
7/02/2005
Date registered
8/02/2005
Date last updated
14/06/2021
Titles & IDs
Public title
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
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Scientific title
Standard Risk B-precursor Acute Lymphoblastic Leukemia (ALL)
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Secondary ID [1]
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NCI-2009-00302
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Secondary ID [2]
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AALL0331
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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:
Acute Lymphoblastic Leukemia
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Childhood B Acute Lymphoblastic 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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0
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Cancer
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0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - 3-Dimensional Conformal Radiation Therapy
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Cytarabine
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Doxorubicin Hydrochloride
Treatment: Drugs - Leucovorin Calcium
Treatment: Drugs - Mercaptopurine
Treatment: Drugs - Methotrexate
Treatment: Drugs - Pegaspargase
Treatment: Drugs - Thioguanine
Treatment: Drugs - Vincristine Sulfate
Experimental: Group 0 Induction Therapy - All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) \< 0.1% OR MRD \>= 0.1% and \< 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD \>= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.
Active comparator: Group 1-SR-low ALL, Arm I (combination chemotherapy) - Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard delayed intensification (DI) therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years
Experimental: Group 1-SR-low ALL, arm II (combination chemotherapy) - Patients receive experimental consolidation therapy, experimental interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
Active comparator: Group 2-SR-avg ALL, arm I (combination chemotherapy) - Patients receive standard consolidation therapy, standard interim maintenance therapy, and standard DI therapy as in group 1, arm I, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
Experimental: Group 2-SR-avg ALL, arm II (combination chemotherapy) - Patients receive standard consolidation therapy, augmented interim maintenance therapy, augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
Active comparator: Group 2-SR-avg ALL, arm III (combination chemotherapy) - Patients receive intensified consolidation therapy, standard interim maintenance therapy, and standard DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
Active comparator: Group 2-SR-avg ALL, arm IV (combination chemotherapy) - Patients receive intensified consolidation therapy, augmented interim maintenance therapy, and augmented DI therapy, followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
Experimental: Group 3-SR-high ALL, combination chemotherapy - Patients receive intensified consolidation therapy, augmented interim maintenance therapy (2 courses), and augmented DI therapy (2 courses), followed by maintenance therapy. Therapies are given by mouth, injection, and infusion for up to 2 or 3 years.
Treatment: Other: 3-Dimensional Conformal Radiation Therapy
Some patients undergo cranial radiotherapy
Treatment: Drugs: Cyclophosphamide
Given IV
Treatment: Drugs: Cytarabine
Given IV or SC
Treatment: Drugs: Dexamethasone
Given IV or PO
Treatment: Drugs: Doxorubicin Hydrochloride
Given IV or IT
Treatment: Drugs: Leucovorin Calcium
Given PO
Treatment: Drugs: Mercaptopurine
Given PO
Treatment: Drugs: Methotrexate
Given IM or IT
Treatment: Drugs: Pegaspargase
Given IM
Treatment: Drugs: Thioguanine
Given PO
Treatment: Drugs: Vincristine Sulfate
Given IV
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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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 (EFS) for SR-Average ALL Patients
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Assessment method [1]
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EFS for SR-Average with standard and Intensified Consolidation. Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
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Timepoint [1]
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6 years
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Primary outcome [2]
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Event-free Survival (EFS) for SR-Low Patients
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Assessment method [2]
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Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
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Timepoint [2]
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6 years
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Secondary outcome [1]
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Health-related Quality of Life Relative to Physical, Social and Emotional Impairment
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Assessment method [1]
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To identify potentially modifiable factors associated with impaired health related quality of life (HRQOL) at different periods of therapy in the patients who are SR-average enrolled on the standard risk ALL study.Standardized scores will be computed for child function using the gender and age-adjusted scores available from normative data from a healthy population of about 10,000 children. The various domains of family functioning will be assessed using well-validated instruments and analyzed as a dichotomous variable (impaired vs. non-impaired family functioning). Multiple regression analysis will be used to test the effect of family functioning (adjusted for therapy given, age at diagnosis, gender, socioeconomic status and other factors) on child function.
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Timepoint [1]
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At 1, 6 and 12 months after diagnosis and, 3 months post-therapy
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Secondary outcome [2]
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Event-Free Survival Probability According to MRD Status End Induction (Day 29)
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Assessment method [2]
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Event-Free survival by Day 29 MRD status (negative vs positive), Event Free Probability (time from study entry to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
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Timepoint [2]
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MRD at Day 29 of therapy
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Secondary outcome [3]
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Overall Survival Probability (OS) According to Induction Day 29 MRD Status
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Assessment method [3]
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Overall survival by Day 29 MRD status (negative vs positive), Overall survival defined as time from study entry to death or date of last contact for patients who are alive.
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Timepoint [3]
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Overall Survival Probability of 6 years
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Secondary outcome [4]
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Early Marrow Status (EMS) by MRD Status End Induction (Day 29)
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Assessment method [4]
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Early Marrow Status defined as M1 versus M2/M3 marrow is correlated with MRD (Positive vs. Negative)
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Timepoint [4]
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Early Marrow Status at Day 15, MRD Status at Day 29 of therapy.
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Secondary outcome [5]
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Optimal Time Point for Advance Health Related Quality of Life Intervention
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Assessment method [5]
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Percentage of patients with elevated Anxiety.
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Timepoint [5]
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At 1 month after diagnosis and 3 months post-therapy.
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Secondary outcome [6]
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Event-free Survival (EFS) for SR-High Patients.
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Assessment method [6]
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Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
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Timepoint [6]
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6 years
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Secondary outcome [7]
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Event-Free Survival (EFS) for Low MRD (Negative) Subjects by Genetic Subset (TEL/Trisomy Positive vs Negative)
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Assessment method [7]
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Event-free probability where EFS is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
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Timepoint [7]
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6 years
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Eligibility
Key inclusion criteria
* Patients must be enrolled on AALL03B1 prior to enrollment on AALL0331
* Initial white blood cells (WBC) < 50,000/ul
* Newly diagnosed B-precursor acute lymphoblastic leukemia
* Standard-risk (SR) disease meeting 1 of the following criteria:
* SR-average by age and WBC
* No unfavorable features
* Rapid early responder (RER) by day 15
* CNS 1 or 2
* Minimal residual disease (MRD) negative on day 29
* Trisomies of 4, 10, and 17 or TEL-AML1 translocation and RER and CNS2 allowed
* SR-low by age and WBC
* No unfavorable features
* RER by day 15
* MRD negative on day 29
* CNS1
* Favorable cytogenetics-trisomies of 4, 10, and 17 or TEL-AML translocation
* SR-high
* Unfavorable features meeting = 1 of the following criteria:
* MLL rearrangements and RER
* Steroid pretreatment
* CNS3
* Slow early responder by morphology or MRD
* Patients with Down syndrome are allowed
* Patients with overt testicular disease are not eligible for this study, but may be eligible for AALL0232
* Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and intrathecal cytarabine; intrathecal chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; (Note: the central nervous system [CNS] status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment
* Patients receiving prior steroid therapy may be eligible for AALL0331 study
* Patients with a contraindication to additional asparaginase therapy, following Induction, are not eligible for the Standard Risk-Low study, and should be removed from protocol therapy at the end of Induction
* Patients who are assigned to the standard risk-average group following Induction and who meet the HRQOL
* Age at diagnosis >= 2 years (note that this is a more restrictive age range than for the therapeutic component of the study)
* At least one parent with reading comprehension of English or Spanish languages for which validated surveys exist
* Diagnosis at one of the institutions participating in this limited institution correlative study
* A parent or legal guardian must sign a written informed consent/parental permission for all patients
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
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Minimum age
1
Year
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Maximum age
9
Years
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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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Type of endpoint/s
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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
11/04/2005
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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
31/03/2021
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Sample size
Target
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Accrual to date
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Final
5377
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
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Recruitment hospital [1]
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Royal Brisbane and Women's Hospital - Herston
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Royal Children's Hospital-Brisbane - Herston
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Women's and Children's Hospital-Adelaide - North Adelaide
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Royal Children's Hospital - Parkville
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Princess Margaret Hospital for Children - Perth
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4029 - Herston
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5006 - North Adelaide
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3052 - Parkville
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6008 - Perth
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Lausanne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Ethics approval
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Summary
Brief summary
This randomized phase III trial is studying different combination chemotherapy regimens and comparing how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia. 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. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
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Trial website
https://clinicaltrials.gov/study/NCT00103285
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Trial related presentations / publications
Wood B, Wu D, Crossley B, Dai Y, Williamson D, Gawad C, Borowitz MJ, Devidas M, Maloney KW, Larsen E, Winick N, Raetz E, Carroll WL, Hunger SP, Loh ML, Robins H, Kirsch I. Measurable residual disease detection by high-throughput sequencing improves risk stratification for pediatric B-ALL. Blood. 2018 Mar 22;131(12):1350-1359. doi: 10.1182/blood-2017-09-806521. Epub 2017 Dec 28. Karol SE, Mattano LA Jr, Yang W, Maloney KW, Smith C, Liu C, Ramsey LB, Fernandez CA, Chang TY, Neale G, Cheng C, Mardis E, Fulton R, Scheet P, San Lucas FA, Larsen EC, Loh ML, Raetz EA, Hunger SP, Devidas M, Relling MV. Genetic risk factors for the development of osteonecrosis in children under age 10 treated for acute lymphoblastic leukemia. Blood. 2016 Feb 4;127(5):558-64. doi: 10.1182/blood-2015-10-673848. Epub 2015 Nov 20. Teachey DT, Rheingold SR, Maude SL, Zugmaier G, Barrett DM, Seif AE, Nichols KE, Suppa EK, Kalos M, Berg RA, Fitzgerald JC, Aplenc R, Gore L, Grupp SA. Cytokine release syndrome after blinatumomab treatment related to abnormal macrophage activation and ameliorated with cytokine-directed therapy. Blood. 2013 Jun 27;121(26):5154-7. doi: 10.1182/blood-2013-02-485623. Epub 2013 May 15.
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Public notes
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Contacts
Principal investigator
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Kelly W Maloney
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Children's Oncology Group
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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
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00103285
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