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
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Lymphocytic, Acute||Drug: 6-mercaptopurine||Phase 2|
In addition to the details above we will also explore
- the relationship of the post-HD-MTX MRD-levels with the dose of 6MP, TPMT-activity, DNA-6TGN, E-6TGN, E-MeMP, E-MTX, and presence of ASP-antibodies,
- the early development of anti-ASP antibodies during continuous PEG-ASP therapy.
The study could improve the understanding of the pharmacodynamics of the 6MP/HD-MTX interaction in combination with PEG-ASP.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Individual 6-mercaptopurine(6MP) Dose Increments in Children With Acute Lymphoblastic Leukemia (ALL) Receiving High-dose Methotrexate (HDM) and PEG-asparaginase|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||May 2009|
Experimental: 6 mercaptopurine arm
All patients received basic daily 6MP (6-mercaptopurine) (25 mg/m^2) and in addition high-dose methotrexate(HDM) every 3rd week (3 times HDM in total) and PEG-asparaginase every 14th day. Patients increased the dose of 6MP 2 weeks after each HDM if if the myelotoxicity had been acceptable. This means 2 increments since the study stopped 2 weeks after the last HDM
Standard dose 25 mg/m^2/day. Can be increased up to 75 mg/m^2/day if the myelosuppression is acceptable (ANC>0.5 T-count >50)
Other Name: PURINETHOL
- Toxicity of Treatment in Terms of Number of Participants With Serious Adverse Events or Adverse Events, Reported [ Time Frame: 3 months ( 79 days ) ]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.
- Incorporation of 6-thioguanine Nucleotides (6TGN) Into Leukocyte DNA, Development of Asparaginase Antibody Production [ Time Frame: During the 3 months consolidation therapy ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548431
|Department of Pediatrics, Rigshospitalet|
|Department of Pediatrics, University Hospital|
|Department of Pediatrics, Drottning Sylvias Pediatric Hospital|
|Study Chair:||Kjeld Schmiegelow, M.D.||Pediatric Clinic II, RIgshospitalet, Copenhagen, DK-2100|