Phase 2
N=38
NOPHO ALL-2008 Pilot Study on Consolidation Therapy for Children and Adolescents With Acute Lymphoblastic Leukemia
Leukemia, Lymphocytic, Acute
Bottom Line
View on ClinicalTrials.gov: NCT00548431 ↗Enrolled (actual)
38
Serious AEs
68.4%
Results posted
Nov 2010
Primary outcome: Primary: Toxicity of Treatment in Terms of Number of Participants With Serious Adverse Events or Adverse Events, Reported — 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 6-mercaptopurine (Drug)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- Rigshospitalet, Denmark
- Primary completion
- Jan 2009
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 |
— | — |
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.
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
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.