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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:
ClinicalTrials.gov Identifier:
NCT00548431
First Posted: October 24, 2007
Last Update Posted: January 9, 2017
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.
Information provided by (Responsible Party):
Kjeld Schmiegelow, Rigshospitalet, Denmark
Results First Submitted: June 24, 2009  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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]
Count of Participants
 
<=18 years      38 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 7  (3) 
Gender 
[Units: Participants]
Count of Participants
 
Female      21  55.3% 
Male      17  44.7% 
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:   02/2018  


  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
No text entered.


  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
First Submitted: October 23, 2007
First Posted: October 24, 2007
Results First Submitted: June 24, 2009
Results First Posted: November 3, 2010
Last Update Posted: January 9, 2017