NCT00548431

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

The present pharmacokinetic (PK)-pharmacodynamic (PD) study will explore the toxicity and antileukemic response during the initial 3 months of individualised therapy of children and young adults with acute lymphoblastic leukemia (ALL). The investigators will on an individual toxicity-titrated basis attempt to increase the dose intensity of the 6-mercaptopurine used in the two-months post-remission treatment phase of lower risk childhood ALL. This will be performed together with continuous PEG-ASP (every 2nd week) and interspersed HD-MTX (5 g/m\^2) every 3rd week. Thus, the trial will also test the feasibility of this particular drug combination.

Detailed description

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.

Conditions

• Leukemia, Lymphocytic, Acute

Interventions

Type	Name	Description
DRUG	6-mercaptopurine	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)

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-01-01
• Completion: 2009-05-01
• First posted: 2007-10-24
• Last updated: 2017-01-09
• Results posted: 2010-11-03

Locations

3 sites across 2 countries: Denmark, Sweden