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ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy

NCT00816049 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 775

Last updated 2017-04-21

No results posted yet for this study

Summary

The purpose of this study is to increase the fraction of patients, who become MRD-negative during consolidation for the non-HR ALL group through individualized intensification of the 6MP-dosage days 30-85.

Conditions

Interventions

DRUG

6MPindividualized

Oral 6-mercaptopurine with a starting dose of 25 mg/m2 and upward adjusted in steps of 25 mg/m2 (i.e. 50 or 75 mg/m2) if unacceptable bone-marrox toxicity is not encountered

DRUG

6MPfixed

Oral 6-mercaptopurine at a fixed dose of 25 mg/m2 treatment days 30-85

Sponsors & Collaborators

  • Nordic Society for Pediatric Hematology and Oncology

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Kjeld Schmiegelow, M.D. · Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2016-03-02
Completion
2016-03-02

Countries

  • Denmark
  • Finland
  • Iceland
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

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 NCT00816049 on ClinicalTrials.gov