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

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ClinicalTrials.gov Identifier: NCT00548431
Recruitment Status : Completed
First Posted : October 24, 2007
Results First Posted : November 3, 2010
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Kjeld Schmiegelow, Rigshospitalet, Denmark

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
Enrollment 38
Recruitment Details 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  
Arm/Group Title 6-mercaptopurine
Hide Arm/Group Description 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
Period Title: Overall Study
Started 38
Completed 38
Not Completed 0
Arm/Group Title 6-mercaptopurine
Hide Arm/Group Description 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
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
<=18 years
38
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants
7  (3)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
21
  55.3%
Male
17
  44.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants
Denmark 12
Sweden 21
Finland 5
1.Primary Outcome
Title Toxicity of Treatment in Terms of Number of Participants With Serious Adverse Events or Adverse Events, Reported
Hide Description Number of participants following the protocol treatment for the full consolidation therapy with toxicity in this pilot study trying to individually titrate 6-mercaptopurine to the highest tolerable level during Consolidation.
Time Frame 3 months ( 79 days )
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 6-mercaptopurine
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 38
Measure Type: Number
Unit of Measure: Participants
26
2.Secondary Outcome
Title Incorporation of 6-thioguanine Nucleotides (6TGN) Into Leukocyte DNA, Development of Asparaginase Antibody Production
Hide Description Biweekly bloodsamples during the 3 months are analyzed for 6TGN incorporation into leucocyte DNA. In addition Methylated Mercaptopurine (MeMP) and Erythrocyte-Methotrexate level is measured
Time Frame During the 3 months consolidation therapy
Outcome Measure Data Not Reported
Time Frame Adverse events were reported for each patient for a period of 3 months
Adverse Event Reporting Description Adverse events were recorded in a bi-weekly questionaire to be filled by physician and patient/parents.
 
Arm/Group Title 6-mercaptopurine
Hide Arm/Group Description 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
All-Cause Mortality
6-mercaptopurine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
6-mercaptopurine
Affected / at Risk (%) # Events
Total   26/38 (68.42%)    
Congenital, familial and genetic disorders   
neutropenic fever  [1]  22/38 (57.89%)  30
Gastrointestinal disorders   
pancreatitis * [2]  1/38 (2.63%)  1
Hepatobiliary disorders   
Hypoglycemia * [3]  2/38 (5.26%)  2
Nervous system disorders   
PRES (Posterior Reversible Encephalopathy Syndrome) * [4]  1/38 (2.63%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
admission to hospital for neutropenic fever is expected during leukemia treatment in the consolidation phase. Usually patients are admitted for i.v. antibiotic treatment for 5-10 days depending on neutropenia and agent.
[2]
grade 4 pancreatitis
[3]
2 patients had hypoglycemia due to liver toxicity. Not an unusual event during 6MP treatment, but somewhat early in the treatment. Both had to be hospitalized longer due to this adverse event.
[4]
Hypertension and PRES in connection with High Dose Methotrexate.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
6-mercaptopurine
Affected / at Risk (%) # Events
Total   23/38 (60.53%)    
Gastrointestinal disorders   
pain  [1]  23/38 (60.53%)  55
mucositis  [2]  22/38 (57.89%)  30
nausea and vomiting   21/38 (55.26%)  68
Indicates events were collected by systematic assessment
[1]
pain is also expected during treatment of leukemia in childhool. Most common pain from abdomen or legs or mouth (stomatitis)
[2]
Mucositis following chemotherapy-mostly high dose Methotrexate in combination with 6MP
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
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