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Phase II Study of Individual 6-mercaptopurine(6MP) Dose Increments in Children With Acute Lymphoblastic Leukemia (ALL) Receiving High-dose Methotrexate (HDM) and PEG-asparaginase


Phase 2
1 Year
18 Years
Not Enrolling
Both
Leukemia, Lymphocytic, Acute

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Trial Information

Phase II Study of Individual 6-mercaptopurine(6MP) Dose Increments in Children With Acute Lymphoblastic Leukemia (ALL) Receiving High-dose Methotrexate (HDM) and PEG-asparaginase


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity of Treatment in Terms of Number of Participants With Serious Adverse Events or Adverse Events, Reported

Outcome Description:

Number of participants following the protocol treatment for the full consolidation therapy with toxicity in this pilot study trying to individually titrate 6-mercaptopurine to the highest tolerable level during Consolidation.

Outcome Time Frame:

3 months ( 79 days )

Safety Issue:

Yes

Principal Investigator

Kjeld Schmiegelow, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Pediatric Clinic II, RIgshospitalet, Copenhagen, DK-2100

Authority:

Denmark: Danish Dataprotection Agency

Study ID:

NOPHO HDM-6MP pilot study

NCT ID:

NCT00548431

Start Date:

December 2007

Completion Date:

May 2009

Related Keywords:

  • Leukemia, Lymphocytic, Acute
  • Leukemia, Lymphocytic, Acute [C04.557.337.428.511]
  • 6-mercaptopurine
  • methotrexate
  • asparaginase
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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