IMPROVING THIOPURINE/METHOTREXATE MAINTENANCE THERAPY OF CHILDHOOD ACUTE LYMPHOBLASTIC LEUKAEMIA - 6MP/6TG

Status

Active, not recruiting

Phases

Phase 1Phase 2Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004090-26-DK

Enrollment

Registered

2007-10-02

Start date

2008-03-25

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leucemia in children and adolescents MedDRA version: 9.1 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia

Interventions

Trade Name: Puri-Nethol Product Name: Puri-Nethol Pharmaceutical Form: Tablet INN or Proposed INN: MERCAPTOPURINE CAS Number: 6112-76-1 Other descriptive name: MERCAPTOPURINE Concentration unit: mg mi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. HR-ALL without translocation t(12;21) or high-hyperdiploidy (both sexes) 2. On oral 6MP/MTX maintenance therapy with =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: If one of the above inclusion criteria is not met, inclusion is not possible

Design outcomes

Primary

Measure	Time frame
Main Objective: To improve the understanding of the pharmacodynamics of maintenance therapy we will establish guidelines for combined 6-thioguanine (6TG)/6MP/MTX therapy. This includes: a. Maximal tolerated doses b. Toxicities encountered during the therapy ;Secondary Objective: Changes in E-6TGN, E-MeMP, E-MTX and DNA-6TGN during this combination chemotherapy;Primary end point(s): 5. Measures of efficacy 5.1 Primary measures of efficacy · Maximal tolerated doses · Toxicities encountered during the therapy Patients and parents will be interviewed at every weekly consultation in regards to side effects. In addition parents and patients are encouraged to contact the department in case of possible side effects. Patients and parents will keep a diary throughout the study. 5.2 Secondary measures of efficacy · E-6TGN, E-MeMP, E-MTX og DNA-6TGN After completion of the trial, each patient will be followed with clinical examinations and laboratory tests on a regular basis for 5 years according to standard follow-up protocols for Child leukemia (the NOPHO-ALL-2000 protocol). Follow-up will include possible side-effects.	—

Measure

Time frame

Main Objective: To improve the understanding of the pharmacodynamics of maintenance therapy we will establish guidelines for combined 6-thioguanine (6TG)/6MP/MTX therapy. This includes: a. Maximal tolerated doses b. Toxicities encountered during the therapy ;Secondary Objective: Changes in E-6TGN, E-MeMP, E-MTX and DNA-6TGN during this combination chemotherapy;Primary end point(s): 5. Measures of efficacy 5.1 Primary measures of efficacy · Maximal tolerated doses · Toxicities encountered during the therapy Patients and parents will be interviewed at every weekly consultation in regards to side effects. In addition parents and patients are encouraged to contact the department in case of possible side effects. Patients and parents will keep a diary throughout the study. 5.2 Secondary measures of efficacy · E-6TGN, E-MeMP, E-MTX og DNA-6TGN After completion of the trial, each patient will be followed with clinical examinations and laboratory tests on a regular basis for 5 years according to standard follow-up protocols for Child leukemia (the NOPHO-ALL-2000 protocol). Follow-up will include possible side-effects.

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026