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Search / Trial NCT00548431

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

Launched by RIGSHOSPITALET, DENMARK · Oct 23, 2007

Trial Information

Current as of May 20, 2025

Completed

Keywords

Leukemia, Lymphocytic, Acute [C04.557.337.428.511] 6 Mercaptopurine Methotrexate Asparaginase

ClinConnect Summary

In addition to the details above we will also explore

* the relationship of the post-HD-MTX MRD-levels with the dose of 6MP, TPMT-activity, DNA-6TGN, E-6TGN, E-MeMP, E-MTX, and presence of ASP-antibodies,
* the early development of anti-ASP antibodies during continuous PEG-ASP therapy.

The study could improve the understanding of the pharmacodynamics of the 6MP/HD-MTX interaction in combination with PEG-ASP.

Gender

ALL

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

About Rigshospitalet, Denmark

Rigshospitalet, located in Copenhagen, Denmark, is one of the leading hospitals in Scandinavia and a prominent center for clinical research and innovation. As a key academic institution affiliated with the University of Copenhagen, Rigshospitalet is dedicated to advancing healthcare through rigorous clinical trials and groundbreaking research across various medical disciplines. The hospital’s commitment to excellence is reflected in its multidisciplinary approach, collaboration with international research networks, and focus on improving patient outcomes through evidence-based practices. With state-of-the-art facilities and a team of highly qualified professionals, Rigshospitalet plays a crucial role in translating scientific discoveries into effective treatments and therapies.

Locations

Copenhagen, , Denmark

Odense, , Denmark

Gothenburg, , Sweden

Patients applied

0 patients applied

Trial Officials

Kjeld Schmiegelow, M.D.

Study Chair

Pediatric Clinic II, RIgshospitalet, Copenhagen, DK-2100

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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