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

NCT ID: NCT00548431

Last Updated: 2017-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-05-31

Brief 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.

Detailed Description

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.

Conditions

Leukemia, Lymphocytic, Acute

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

6 mercaptopurine arm

All patients received basic daily 6MP (6-mercaptopurine) (25 mg/m\^2) and in addition high-dose methotrexate(HDM) every 3rd week (3 times HDM in total) and PEG-asparaginase every 14th day. Patients increased the dose of 6MP 2 weeks after each HDM if if the myelotoxicity had been acceptable. This means 2 increments since the study stopped 2 weeks after the last HDM

Group Type: EXPERIMENTAL

6-mercaptopurine

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

Other Intervention Names

PURINETHOL

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Kjeld Schmiegelow

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kjeld Schmiegelow, M.D.

Role: STUDY_CHAIR

Pediatric Clinic II, RIgshospitalet, Copenhagen, DK-2100

Locations

Department of Pediatrics, Rigshospitalet

Copenhagen, , Denmark

Department of Pediatrics, University Hospital

Odense, , Denmark

Department of Pediatrics, Drottning Sylvias Pediatric Hospital

Gothenburg, , Sweden

Countries

Denmark; Sweden

Other Identifiers

NOPHO HDM-6MP pilot study

Identifier Type: -

Identifier Source: org_study_id