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Therapy for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00137111
Recruitment Status : Completed
First Posted : August 29, 2005
Results First Posted : April 26, 2011
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoblastic Leukemia, Acute
Interventions Drug: Prednisone, Dexamethasone, Vincristine, Daunorubicin
Drug: Doxorubicin, L-asparaginase, PEG-L-asparaginase, Erwinia asparaginase
Drug: Methotrexate, Cyclophosphamide, Cytarabine, Etoposide
Drug: Mercaptopurine, Imatinib
Procedure: chemotherapy, intrathecal chemotherapy
Procedure: steroid therapy, hematopoietic stem cell transplantation
Enrollment 501
Recruitment Details 501 patients were recruited between June 2000 and October 2007.
Pre-assignment Details 501 patients were enrolled on the study. 3 patients were determined to be ineligible shortly after enrollment (wrong diagnosis – AML or CML in blast crisis).498 patients started the study.
Arm/Group Title Total Therapy 4 hr 24 hr Non Randomized
Hide Arm/Group Description Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy. 4 hour High-Dose Methotrexate Infusion in upfront window treatment 24 hour High-Dose Methotrexate Infusion in upfront window treatment Patients not randomized for window study
Period Title: Window Therapy
Started 0 176 180 142
Completed 0 176 180 142
Not Completed 0 0 0 0
Period Title: Total Therapy
Started 498 0 0 0
Completed 458 0 0 0
Not Completed 40 0 0 0
Reason Not Completed
Death             35             0             0             0
Non Compliance             5             0             0             0
Arm/Group Title Total Therapy 4 hr 24 hr Non Randomized Total
Hide Arm/Group Description Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy. 4 hour High-Dose Methotrexate Infusion in upfront window treatment 24 hour High-Dose Methotrexate Infusion in upfront window treatment Patients not randomized for window study Total of all reporting groups
Overall Number of Baseline Participants 498 0 0 0 498
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 498 participants 0 participants 0 participants 0 participants 498 participants
1 to 9 years 372 372
>=10 years 126 126
[1]
Measure Description: Prior experience indicate different responses for children under the age of ten and those who are 10 and older.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 498 participants 0 participants 0 participants 0 participants 498 participants
Female
219
  44.0%
219
  44.0%
Male
279
  56.0%
279
  56.0%
1.Primary Outcome
Title Overall Event-free Survival (EFS)
Hide Description EFS was measured from the start of on-study to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Failure to enter remission was considered an event at time zero. Measurement was determined by Kaplan-Meyer estimate.
Time Frame Median follow-up time (range) 5.6 (1.3 to 8.9) years
Hide Outcome Measure Data
Hide Analysis Population Description
498 enrolled patients were eligible for analysis to estimate the overall event-free survival of children at least one year of age at diagnosis who are treated with risk-directed therapy.
Arm/Group Title Total Therapy
Hide Arm/Group Description:
Total therapy applies to all eligible patients.
Overall Number of Participants Analyzed 498
Measure Type: Number
Unit of Measure: Percentage of Participants
87.3
2.Primary Outcome
Title Continuous Complete Remission Since Week 56 Therapy.
Hide Description CCR was measured from end of week 56 therapy to the date of first treatment failure of any kind (relapse, death, lineage switch, or second malignancy) or to the last date of follow-up. Measurement was determined by Kaplan-Meyer estimate.
Time Frame Median follow up time (range) 4.5 (1 to 7.8) years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients meeting the following high risk CNS Relapse criteria: white cell blood cell count at diagnosis more than 100,000; Philadelphia Chromosome Positive; CNS 3 at diagnosis; T-Lineage with white blood cell count more than 50,000.
Arm/Group Title Patients With High Risk of CNS Relapse
Hide Arm/Group Description:
This is a subset of all patients enrolled. It is not a specific treatment arm.
Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: Percentage of participants
92.2
3.Secondary Outcome
Title Minimal Residual Disease (MRD)
Hide Description Detection of MRD at end of induction where positive MRD was defined as one or more leukemic cell per 10,000 mononuclear bone-marrow cells (>=0.01%).
Time Frame End of Induction (Day 46 MRD measurement)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed induction and had successful MRD studies on day 46.
Arm/Group Title Total Therapy
Hide Arm/Group Description:
Total therapy applies to all eligible patients.
Overall Number of Participants Analyzed 492
Measure Type: Number
Unit of Measure: participants
Negative <0.01% 390
Positive >= 0.01% 102
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Therapy
Comments Of the 498 eligible patients, 492 were successfully evaluated with day 46 MRD measurement.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Binomial proportion
Comments [Not Specified]
Method of Estimation Estimation Parameter Binomial proportion
Estimated Value 79.27
Confidence Interval (2-Sided) 95%
75.69 to 82.85
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours).
Hide Description Children were randomly assigned to receive initial single-agent treatment with HDMTX (1g/m^2) as either a 24-hour infusion or a 4-hour infusion and the outcome measure was the accumulation of MTXPG in leukemia cells.
Time Frame 42 hours after start of high dose methotrexate infusion (HDMTX)
Hide Outcome Measure Data
Hide Analysis Population Description
The 286 patients randomized to treatment with high-dose methotrexate (HDMTX) who had methotrexate polyglutamate (MTXPG) concentration measured in bone marrow ALL cells .
Arm/Group Title 4 hr 24 hr
Hide Arm/Group Description:
4 hour High-Dose Methotrexate Infusion in upfront window treatment
24 hour High-Dose Methotrexate Infusion in upfront window treatment
Overall Number of Participants Analyzed 136 150
Mean (Standard Deviation)
Unit of Measure: pmol/1,000,000,000 cells
1688  (2015) 2521  (2950)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 4 hr, 24 hr
Comments t-test stratified for lineage and ploidy
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0062
Comments p-value from t-test after stratified for lineage and ploidy
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours)
Hide Description

White blood cell (leukocytes) counts in peripheral blood by Complete Blood Count

Measurement: Percentage change of leukemia cells from baseline

Time Frame Immediately before the methotrexate infusion and three days after subsequent infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Three hundred twenty (320) patients were evaluable to assess the influence of infusion duration on methotrexate’s antileukemic effects.
Arm/Group Title 4 hr 24 hr
Hide Arm/Group Description:
4 hour High-Dose Methotrexate Infusion in upfront window treatment
24 hour High-Dose Methotrexate Infusion in upfront window treatment
Overall Number of Participants Analyzed 156 164
Mean (Standard Deviation)
Unit of Measure: Percent change
-44  (42.2) -50  (35.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 4 hr, 24 hr
Comments t-test adjusting for lineage and ploidy
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .15
Comments p-value from t-test after adjusted for lineage and ploidy
Method t-test, 2 sided
Comments [Not Specified]
6.Other Pre-specified Outcome
Title Median Difference in CASP1 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs Glucocorticoid-sensitive Cells
Hide Description Prednisolone sensitivity was measured in primary leukemia cells from bone marrow collected at diagnosis. Expression of CASP1 was determined by HG-U133A microarray. Values given are gene expression values, and the unit is arbitrary units (AU) defined as scaled fluorescence measured on microarray.
Time Frame Pre-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
One hundred forty-four (144) patients were evaluable to assess prednisolone sensitivity measured in bone marrow ALL cells and CASP1 expression in RNA by MTT assay.
Arm/Group Title Total Therapy
Hide Arm/Group Description:
Total therapy applies to all eligible patients.
Overall Number of Participants Analyzed 144
Median (Inter-Quartile Range)
Unit of Measure: arbitrary units
Prednisolone-sensitive cells
341.3
(202.1 to 430.2)
Prednisolone-resistant cells
447.9
(332.2 to 544.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00000095
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Other Pre-specified Outcome
Title Median Difference in NLRP3 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs. Glucocorticoid-sensitive Cells
Hide Description Prednisolone sensitivity was measured in primary leukemia cells from bone marrow collected at diagnosis. Expression of NLRP3 was determined by HG-U133A microarray. Values given are gene expression values, and the unit is arbitrary units (AU) defined as scaled fluorescence measured on microarray.
Time Frame Pre-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
One hundred forty-four (144) patients were evaluable to assess prednisolone sensitivity measured in bone marrow ALL cells and NLRP3 expression in RNA by MTT assay
Arm/Group Title Total Therapy
Hide Arm/Group Description:
Total therapy applies to all eligible patients.
Overall Number of Participants Analyzed 144
Median (Inter-Quartile Range)
Unit of Measure: arbitrary units
Prednisolone-sensitive cells
41.2
(31.4 to 58.7)
Prednisolone-resistant cells
110.7
(59.7 to 157.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0000007
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Participants were monitored from the start of therapy through 30 days after this protocol's treatment plan was completed.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Total Therapy
Hide Arm/Group Description Total therapy applies to all eligible patients.
All-Cause Mortality
Total Therapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Total Therapy
Affected / at Risk (%) # Events
Total   74/498 (14.86%)    
Blood and lymphatic system disorders   
CNS hemorrhage/bleeding * 1  2/498 (0.40%)  2
DIC (disseminated intravascular coagulation) * 1  2/498 (0.40%)  2
Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia * 1  1/498 (0.20%)  1
Cardiac disorders   
Hypertension * 1  2/498 (0.40%)  2
Hypotension * 1  9/498 (1.81%)  9
Sinus tachycardia * 1  1/498 (0.20%)  1
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter) * 1  1/498 (0.20%)  1
Thrombosis/embolism * 1  5/498 (1.00%)  5
Eye disorders   
Vision-blurred vision * 1  1/498 (0.20%)  1
Gastrointestinal disorders   
Colitis * 1  4/498 (0.80%)  4
Pancreatitis * 1  2/498 (0.40%)  2
Renal failure * 1  4/498 (0.80%)  4
Typhlitis (inflammation of cecum) * 1  2/498 (0.40%)  2
Vomiting * 1  1/498 (0.20%)  1
General disorders   
Edema * 1  2/498 (0.40%)  2
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) * 1  3/498 (0.60%)  3
Hepatobiliary disorders   
Bilirubin * 1  1/498 (0.20%)  1
Hepatic-Other * 1  1/498 (0.20%)  1
Liver dysfunction/failure (clinical), * 1  2/498 (0.40%)  2
Immune system disorders   
Allergic Reaction to Asparaginase * 1  6/498 (1.20%)  6
Allergic reaction/hypersensitivity (including drug fever) * 1  2/498 (0.40%)  2
Infections and infestations   
Catheter-related infection * 1  3/498 (0.60%)  3
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 1  3/498 (0.60%)  4
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC <1.0 x 10e * 1  32/498 (6.43%)  32
Infection without neutropenia * 1  5/498 (1.00%)  5
Metabolism and nutrition disorders   
Acidosis (metabolic or respiratory) * 1  2/498 (0.40%)  2
Amylase * 1  1/498 (0.20%)  1
Hyperglycemia * 1  1/498 (0.20%)  1
Hyperkalemia * 1  1/498 (0.20%)  1
Lipase * 1  1/498 (0.20%)  1
Nervous system disorders   
Leukoencephalopathy associated with radiological findings * 1  2/498 (0.40%)  2
Neuropathy-sensory * 1  1/498 (0.20%)  1
Seizure(s) * 1  6/498 (1.20%)  6
Psychiatric disorders   
Personality/behavioral * 1  1/498 (0.20%)  1
Renal and urinary disorders   
Creatinine * 1  1/498 (0.20%)  1
Respiratory, thoracic and mediastinal disorders   
Adult respiratory distress syndrome (ARDS) * 1  11/498 (2.21%)  11
Apnea * 1  2/498 (0.40%)  2
Dyspnea (shortness of breath) * 1  2/498 (0.40%)  2
Hypoxia * 1  10/498 (2.01%)  10
Pleural effusion (non-malignant) * 1  4/498 (0.80%)  4
Pneumonitis/pulmonary infiltrates * 1  3/498 (0.60%)  3
Pulmonary-Other * 1  1/498 (0.20%)  1
Skin and subcutaneous tissue disorders   
Dermatology/Skin-Other * 1  1/498 (0.20%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Total Therapy
Affected / at Risk (%) # Events
Total   468/498 (93.98%)    
Cardiac disorders   
Hypertension * 1  42/498 (8.43%)  42
Hypotension * 1  52/498 (10.44%)  53
Thrombosis/embolism * 1  31/498 (6.22%)  34
Gastrointestinal disorders   
Anorexia * 1  26/498 (5.22%)  31
Dehydration * 1  29/498 (5.82%)  36
Diarrhea patients without colostomy * 1  53/498 (10.64%)  62
Stomatitis/pharyngitis (oral/pharyngeal mucositis), * 1  65/498 (13.05%)  75
Typhlitis * 1  27/498 (5.42%)  37
Vomiting * 1  59/498 (11.85%)  67
General disorders   
Abdominal pain or cramping * 1  47/498 (9.44%)  69
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L) * 1  208/498 (41.77%)  403
Headache * 1  26/498 (5.22%)  38
Hepatobiliary disorders   
SGPT (ALT) * 1  76/498 (15.26%)  100
Immune system disorders   
Allergic Reaction to Asparaginase * 1  41/498 (8.23%)  45
Infections and infestations   
Catheter-related infection * 1  86/498 (17.27%)  131
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 1  436/498 (87.55%)  1407
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia * 1  379/498 (76.10%)  893
Infection without neutropenia * 1  290/498 (58.23%)  594
Metabolism and nutrition disorders   
Hyperglycemia * 1  43/498 (8.63%)  62
Hypokalemia * 1  32/498 (6.43%)  36
Musculoskeletal and connective tissue disorders   
Osteonecrosis * 1  35/498 (7.03%)  60
Nervous system disorders   
Neuropathic pain * 1  46/498 (9.24%)  46
Respiratory, thoracic and mediastinal disorders   
Hypoxia * 1  51/498 (10.24%)  62
Pleural effusion * 1  25/498 (5.02%)  25
Pneumonitis/pulmonary infiltrates * 1  29/498 (5.82%)  33
Skin and subcutaneous tissue disorders   
Wound-infectious * 1  43/498 (8.63%)  48
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ching-Hon Pui
Organization: St. Jude Children's Research Hospital
Phone: 1-866-278-5833
EMail: info@stjude.org
Publications:
Zhang J, Ding L, Holmfeldt L, Wu G, Heatley SL, Payne-Turner D, Easton J, Chen X, Wang J, Rusch M, Lu C, Chen SC, Wei L, Collins-Underwood JR, Ma J, Roberts KG, Pounds SB, Ulyanov A, Becksfort J, Gupta P, Huether R, Kriwacki RW, Parker M, McGoldrick DJ, Zhao D, Alford D, Espy S, Bobba KC, Song G, Pei D, Cheng C, Roberts S, Barbato MI, Campana D, Coustan-Smith E, Shurtleff SA, Raimondi SC, Kleppe M, Cools J, Shimano KA, Hermiston ML, Doulatov S, Eppert K, Laurenti E, Notta F, Dick JE, Basso G, Hunger SP, Loh ML, Devidas M, Wood B, Winter S, Dunsmore KP, Fulton RS, Fulton LL, Hong X, Harris CC, Dooling DJ, Ochoa K, Johnson KJ, Obenauer JC, Evans WE, Pui CH, Naeve CW, Ley TJ, Mardis ER, Wilson RK, Downing JR, Mullighan CG. The genetic basis of early T-cell precursor acute lymphoblastic leukaemia. Nature. 2012 Jan 11;481(7380):157-63. doi: 10.1038/nature10725.
Holmfeldt L, Wei L, Diaz-Flores E, Walsh M, Zhang J, Ding L, Payne-Turner D, Churchman M, Andersson A, Chen SC, McCastlain K, Becksfort J, Ma J, Wu G, Patel SN, Heatley SL, Phillips LA, Song G, Easton J, Parker M, Chen X, Rusch M, Boggs K, Vadodaria B, Hedlund E, Drenberg C, Baker S, Pei D, Cheng C, Huether R, Lu C, Fulton RS, Fulton LL, Tabib Y, Dooling DJ, Ochoa K, Minden M, Lewis ID, To LB, Marlton P, Roberts AW, Raca G, Stock W, Neale G, Drexler HG, Dickins RA, Ellison DW, Shurtleff SA, Pui CH, Ribeiro RC, Devidas M, Carroll AJ, Heerema NA, Wood B, Borowitz MJ, Gastier-Foster JM, Raimondi SC, Mardis ER, Wilson RK, Downing JR, Hunger SP, Loh ML, Mullighan CG. The genomic landscape of hypodiploid acute lymphoblastic leukemia. Nat Genet. 2013 Mar;45(3):242-52. doi: 10.1038/ng.2532. Epub 2013 Jan 20.
Roberts KG, Li Y, Payne-Turner D, Harvey RC, Yang YL, Pei D, McCastlain K, Ding L, Lu C, Song G, Ma J, Becksfort J, Rusch M, Chen SC, Easton J, Cheng J, Boggs K, Santiago-Morales N, Iacobucci I, Fulton RS, Wen J, Valentine M, Cheng C, Paugh SW, Devidas M, Chen IM, Reshmi S, Smith A, Hedlund E, Gupta P, Nagahawatte P, Wu G, Chen X, Yergeau D, Vadodaria B, Mulder H, Winick NJ, Larsen EC, Carroll WL, Heerema NA, Carroll AJ, Grayson G, Tasian SK, Moore AS, Keller F, Frei-Jones M, Whitlock JA, Raetz EA, White DL, Hughes TP, Guidry Auvil JM, Smith MA, Marcucci G, Bloomfield CD, Mrózek K, Kohlschmidt J, Stock W, Kornblau SM, Konopleva M, Paietta E, Pui CH, Jeha S, Relling MV, Evans WE, Gerhard DS, Gastier-Foster JM, Mardis E, Wilson RK, Loh ML, Downing JR, Hunger SP, Willman CL, Zhang J, Mullighan CG. Targetable kinase-activating lesions in Ph-like acute lymphoblastic leukemia. N Engl J Med. 2014 Sep 11;371(11):1005-15. doi: 10.1056/NEJMoa1403088.
Zhang J, McCastlain K, Yoshihara H, Xu B, Chang Y, Churchman ML, Wu G, Li Y, Wei L, Iacobucci I, Liu Y, Qu C, Wen J, Edmonson M, Payne-Turner D, Kaufmann KB, Takayanagi SI, Wienholds E, Waanders E, Ntziachristos P, Bakogianni S, Wang J, Aifantis I, Roberts KG, Ma J, Song G, Easton J, Mulder HL, Chen X, Newman S, Ma X, Rusch M, Gupta P, Boggs K, Vadodaria B, Dalton J, Liu Y, Valentine ML, Ding L, Lu C, Fulton RS, Fulton L, Tabib Y, Ochoa K, Devidas M, Pei D, Cheng C, Yang J, Evans WE, Relling MV, Pui CH, Jeha S, Harvey RC, Chen IL, Willman CL, Marcucci G, Bloomfield CD, Kohlschmidt J, Mrózek K, Paietta E, Tallman MS, Stock W, Foster MC, Racevskis J, Rowe JM, Luger S, Kornblau SM, Shurtleff SA, Raimondi SC, Mardis ER, Wilson RK, Dick JE, Hunger SP, Loh ML, Downing JR, Mullighan CG; St. Jude Children's Research Hospital–Washington University Pediatric Cancer Genome Project. Deregulation of DUX4 and ERG in acute lymphoblastic leukemia. Nat Genet. 2016 Dec;48(12):1481-1489. doi: 10.1038/ng.3691. Epub 2016 Oct 24.
Alexander TB, Gu Z, Iacobucci I, Dickerson K, Choi JK, Xu B, Payne-Turner D, Yoshihara H, Loh ML, Horan J, Buldini B, Basso G, Elitzur S, de Haas V, Zwaan CM, Yeoh A, Reinhardt D, Tomizawa D, Kiyokawa N, Lammens T, De Moerloose B, Catchpoole D, Hori H, Moorman A, Moore AS, Hrusak O, Meshinchi S, Orgel E, Devidas M, Borowitz M, Wood B, Heerema NA, Carrol A, Yang YL, Smith MA, Davidsen TM, Hermida LC, Gesuwan P, Marra MA, Ma Y, Mungall AJ, Moore RA, Jones SJM, Valentine M, Janke LJ, Rubnitz JE, Pui CH, Ding L, Liu Y, Zhang J, Nichols KE, Downing JR, Cao X, Shi L, Pounds S, Newman S, Pei D, Guidry Auvil JM, Gerhard DS, Hunger SP, Inaba H, Mullighan CG. The genetic basis and cell of origin of mixed phenotype acute leukaemia. Nature. 2018 Oct;562(7727):373-379. doi: 10.1038/s41586-018-0436-0. Epub 2018 Sep 12.
Gu Z, Churchman ML, Roberts KG, Moore I, Zhou X, Nakitandwe J, Hagiwara K, Pelletier S, Gingras S, Berns H, Payne-Turner D, Hill A, Iacobucci I, Shi L, Pounds S, Cheng C, Pei D, Qu C, Newman S, Devidas M, Dai Y, Reshmi SC, Gastier-Foster J, Raetz EA, Borowitz MJ, Wood BL, Carroll WL, Zweidler-McKay PA, Rabin KR, Mattano LA, Maloney KW, Rambaldi A, Spinelli O, Radich JP, Minden MD, Rowe JM, Luger S, Litzow MR, Tallman MS, Racevskis J, Zhang Y, Bhatia R, Kohlschmidt J, Mrózek K, Bloomfield CD, Stock W, Kornblau S, Kantarjian HM, Konopleva M, Evans WE, Jeha S, Pui CH, Yang J, Paietta E, Downing JR, Relling MV, Zhang J, Loh ML, Hunger SP, Mullighan CG. PAX5-driven subtypes of B-progenitor acute lymphoblastic leukemia. Nat Genet. 2019 Feb;51(2):296-307. doi: 10.1038/s41588-018-0315-5. Epub 2019 Jan 14.
Layout table for additonal information
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00137111     History of Changes
Other Study ID Numbers: TOTXV
R37CA036401 ( U.S. NIH Grant/Contract )
P30CA021765 ( U.S. NIH Grant/Contract )
F32CA141762 ( U.S. NIH Grant/Contract )
First Submitted: August 25, 2005
First Posted: August 29, 2005
Results First Submitted: February 28, 2011
Results First Posted: April 26, 2011
Last Update Posted: August 28, 2019