Phase 2 Completed N=38 Treatment

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

Source: ClinicalTrials.gov NCT00548431 ↗

Enrolled (actual)

Serious AEs

68.4%

Results posted

Nov 2010

Primary outcomePrimary: Toxicity of Treatment in Terms of Number of Participants With Serious Adverse Events or Adverse Events, Reported — 26 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Toxicity of Treatment in Terms of Number of Participants With Serious Adverse Events or Adverse Events, Reported	26	—
SECONDARY Incorporation of 6-thioguanine Nucleotides (6TGN) Into Leukocyte DNA, Development of Asparaginase Antibody Production	—	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00548431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.