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

NCT00548431 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2017-01-09

Study results available
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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.

Conditions

  • Leukemia, Lymphocytic, Acute

Interventions

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)

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Kjeld Schmiegelow, M.D. · Pediatric Clinic II, RIgshospitalet, Copenhagen, DK-2100

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-01-31
Completion
2009-05-31

Countries

  • Denmark
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00548431 on ClinicalTrials.gov