ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy (ALL2008con)

April 20, 2017 updated by: Kjeld Schmiegelow, Rigshospitalet, Denmark

Nordic Society of Paediatric Haematology and Oncology Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults (18-45 Years of Age) With ALL. Efficacy of Individualised 6MP Dosing During Consolidation Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

20% of children with ALL still fails to be cured. The ALL-2008 protocol is a treatment and research protocol that aims to improve the overall outcome of Nordic children and adolescents with ALL in comparison with the ALL-2000 protocol and previous NOPHO protocols.

The specific and primary objectives of the randomised study is:

To increase the fraction of patients, who become MRD-negative during consolidation for the non-HR ALL group through individualised intensification of the 6MP-dosage days 30-85. We will additionally measure EFS and toxicity as secondary end points of effect.

Study Type

Interventional

Enrollment (Actual)

775

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Department of Pediatrics, Rigshospitalet
  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital
  • Iceland
      • Reykjavik, Iceland
        • University Hospital
  • Norway
      • Trondheim, Norway
        • Trondheim University Hospital
  • Sweden
      • Gothenburg, Sweden
        • Department of Pediatrics, Drottning Sylvias Pediatric Hospital
      • Stockholm, Sweden
        • NOPHO nordic organisation for pediatric onology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Childhood ALL
  • All mandatory biological data are available6
  • Written informed consent has been obtained

Exclusion Criteria:

  • Mixed lineage ALL
  • Pre-treatment with glucocorticosteroids or other antileukemic agents for more than 1 week
  • ALL predisposition syndromes
  • Previous cancer
  • Off protocol administration of additional chemotherapy during induction therapy
  • Sexually active females not using contraception
  • TPMT-deficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 6MPfixed
Fixed dose 6-mercaptopurine days 30-85
Drug: 6MPfixed
Oral 6-mercaptopurine at a fixed dose of 25 mg/m2 treatment days 30-85
Other Names:
  • PuriNethol, Puri-Nethol (6-mercaptopurine)
Experimental: 6MPindividualized
Individualized dose increments of 6-mercaptopurine days 30-85
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
Other Names:
  • PuriNethol, Puri-Nethol (6-mercaptopurine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fraction of patients that become MRD-negative at treatment days 85 and/or 92 (end-of-consolidation) and event-free survival. MRD is measured either by Flow-cytometry (for PreB-ALL patients) or PCR for clonal generearrangements(for T-ALL patients)
Time Frame: 6 years
6 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity of treatment, degree of myelo-, hepato- and renal toxicity; and development of asparaginase antibodies.
Time Frame: 6 years
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Nordic Society for Pediatric Hematology and Oncology

Investigators

  • Study Chair: Kjeld Schmiegelow, M.D., Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Actual)

March 2, 2016

Study Completion (Actual)

March 2, 2016

Study Registration Dates

First Submitted

December 23, 2008

First Submitted That Met QC Criteria

December 30, 2008

First Posted (Estimate)

December 31, 2008

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOPHO ALL2008 consolidation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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