ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 3 for:    22291082 [PUBMED-IDS]

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 : Active, not recruiting
First Posted : August 29, 2005
Results First Posted : April 26, 2011
Last Update Posted : August 29, 2017
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
501 patients were recruited between June 2000 and October 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Total Therapy Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy.
4 hr 4 hour High-Dose Methotrexate Infusion in upfront window treatment
24 hr 24 hour High-Dose Methotrexate Infusion in upfront window treatment
Non Randomized Patients not randomized for window study

Participant Flow for 2 periods

Period 1:   Window Therapy
    Total Therapy   4 hr   24 hr   Non Randomized
STARTED   0   176   180   142 
COMPLETED   0   176   180   142 
NOT COMPLETED   0   0   0   0 

Period 2:   Total Therapy
    Total Therapy   4 hr   24 hr   Non Randomized
STARTED   498   0   0   0 
COMPLETED   458   0   0   0 
NOT COMPLETED   40   0   0   0 
Death                35                0                0                0 
Non Compliance                5                0                0                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Total Therapy Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy.
4 hr 4 hour High-Dose Methotrexate Infusion in upfront window treatment
24 hr 24 hour High-Dose Methotrexate Infusion in upfront window treatment
Non Randomized Patients not randomized for window study
Total Total of all reporting groups

Baseline Measures
   Total Therapy   4 hr   24 hr   Non Randomized   Total 
Overall Participants Analyzed 
[Units: Participants]
 498   0   0   0   498 
Age, Customized [1] 
[Units: Participants]
         
1 to 9 years   372            372 
>=10 years   126            126 
[1] Prior experience indicate different responses for children under the age of ten and those who are 10 and older.
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      219  44.0%               219  44.0% 
Male      279  56.0%               279  56.0% 


  Outcome Measures

1.  Primary:   Overall Event-free Survival (EFS)   [ Time Frame: Median follow-up time (range) 5.6 (1.3 to 8.9) years ]

2.  Primary:   Continuous Complete Remission Since Week 56 Therapy.   [ Time Frame: Median follow up time (range) 4.5 (1 to 7.8) years ]

3.  Secondary:   Minimal Residual Disease (MRD)   [ Time Frame: End of Induction (Day 46 MRD measurement) ]

4.  Secondary:   Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours).   [ Time Frame: 42 hours after start of high dose methotrexate infusion (HDMTX) ]

5.  Secondary:   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)   [ Time Frame: Immediately before the methotrexate infusion and three days after subsequent infusion ]

6.  Other Pre-specified:   Median Difference in CASP1 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs Glucocorticoid-sensitive Cells   [ Time Frame: Pre-treatment ]

7.  Other Pre-specified:   Median Difference in NLRP3 Gene Expression in Primary Leukemia Cells of Patients in Glucocorticoid-resistant Cells vs. Glucocorticoid-sensitive Cells   [ Time Frame: Pre-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ching-Hon Pui
Organization: St. Jude Children's Research Hospital
phone: 1-866-278-5833
e-mail: 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 29, 2017