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NOPHO ALL-2008 Pilot Study on Consolidation Therapy for Children and Adolescents With Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kjeld Schmiegelow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00548431
First received: October 23, 2007
Last updated: October 6, 2016
Last verified: October 2016
Results First Received: June 24, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia, Lymphocytic, Acute
Intervention: Drug: 6-mercaptopurine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
38 patients were recruited in 3 different countries. Recruitment period 12/01/2007 - 12/21/2008. All recruitments were done in departments of Pediatric Hematology/oncology

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
6-mercaptopurine All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable

Participant Flow:   Overall Study
    6-mercaptopurine
STARTED   38 
COMPLETED   38 
NOT COMPLETED   0 



  Baseline Characteristics
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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
6-mercaptopurine All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable

Baseline Measures
   6-mercaptopurine 
Overall Participants Analyzed 
[Units: Participants]
 38 
Age 
[Units: Participants]
 
<=18 years   38 
Between 18 and 65 years   0 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 7  (3) 
Gender 
[Units: Participants]
 
Female   21 
Male   17 
Region of Enrollment 
[Units: Participants]
 
Denmark   12 
Sweden   21 
Finland   5 


  Outcome Measures

1.  Primary:   Toxicity of Treatment in Terms of Number of Participants With Serious Adverse Events or Adverse Events, Reported   [ Time Frame: 3 months ( 79 days ) ]

2.  Secondary:   Incorporation of 6-thioguanine Nucleotides (6TGN) Into Leukocyte DNA, Development of Asparaginase Antibody Production   [ Time Frame: During the 3 months consolidation therapy ]
Results not yet reported.   Anticipated Reporting Date:   12/2017   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Thomas Frandsen
Organization: Rigshospitalet, Juliane Marie Centret
phone: +45 35458364
e-mail: thomas.leth.frandsen@rh.regionh.dk



Responsible Party: Kjeld Schmiegelow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00548431     History of Changes
Other Study ID Numbers: NOPHO HDM-6MP pilot study
Study First Received: October 23, 2007
Results First Received: June 24, 2009
Last Updated: October 6, 2016
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Denmark: The Regional Committee on Biomedical Research Ethics