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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00816049
First Posted: December 31, 2008
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Nordic Society for Pediatric Hematology and Oncology
Information provided by (Responsible Party):
Kjeld Schmiegelow, Rigshospitalet, Denmark
  Purpose
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.

Condition Intervention Phase
Acute Lymphoblastic Leukemia Drug: 6MPindividualized Drug: 6MPfixed Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Kjeld Schmiegelow, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Toxicity of treatment, degree of myelo-, hepato- and renal toxicity; and development of asparaginase antibodies. [ Time Frame: 6 years ]

Enrollment: 775
Actual Study Start Date: January 2009
Study Completion Date: March 2, 2016
Primary Completion Date: March 2, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: PuriNethol, Puri-Nethol (6-mercaptopurine)

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816049


Locations
Denmark
Department of Pediatrics, Rigshospitalet
Copenhagen, Denmark
Finland
Helsinki University Hospital
Helsinki, Finland
Iceland
University Hospital
Reykjavik, Iceland
Norway
Trondheim University Hospital
Trondheim, Norway
Sweden
Department of Pediatrics, Drottning Sylvias Pediatric Hospital
Gothenburg, Sweden
NOPHO nordic organisation for pediatric onology
Stockholm, Sweden
Sponsors and Collaborators
Rigshospitalet, Denmark
Nordic Society for Pediatric Hematology and Oncology
Investigators
Study Chair: Kjeld Schmiegelow, M.D. Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen
  More Information

Additional Information:
Responsible Party: Kjeld Schmiegelow, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00816049     History of Changes
Other Study ID Numbers: NOPHO ALL2008 consolidation
First Submitted: December 23, 2008
First Posted: December 31, 2008
Last Update Posted: April 21, 2017
Last Verified: April 2017

Keywords provided by Kjeld Schmiegelow, Rigshospitalet, Denmark:
acute lymphoblastic leukemia
child
6-mercaptopurine
minimal residual disease
efficacy
childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
6-Mercaptopurine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors