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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: 6-Mercaptopurine; Asparaginase; Mercaptopurine; Methotrexate; Pegaspargase

Criteria

Inclusion Criteria:

• B-lineage ALL

• 1-17.9 years

• WBC <100, clinical remission obtained day 2

• Written consent to participation.

Exclusion Criteria:

• t(9;22)

• Hypodiploidy

• 11q23-aberrations

• TPMT-deficiency

• Intolerance to MTX or 6MP