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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Rigshospitalet, Denmark
Sponsor:
Collaborator:
Nordic Society for Pediatric Hematology and Oncology
Information provided by (Responsible Party):
Kjeld Schmiegelow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00816049
First received: December 23, 2008
Last updated: May 22, 2012
Last verified: May 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 1000
Study Start Date: June 2009
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (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

Ages Eligible for Study:   1 Year to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816049

Contacts
Contact: Kjeld Schmiegelow, M.D. +45 3545 1357 kschmiegelow@rh.dk
Contact: Thomas Frandsen, M.D. +45 3545 8364 t-frandsen@dadlnet.dk

Locations
Denmark
Department of Pediatrics, Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Kjeld Schmiegelow, M.D.    45-3545-1357    kschmiegelow@rh.dk   
Finland
Helsinki University Hospital Recruiting
Helsinki, Finland
Contact: Kim Vettenranta, M.D.    + 35 850-3676528    kim.vettenranta@hus.fi   
Iceland
University Hospital Recruiting
Reykjavik, Iceland
Contact: Olafur Jonsson, M.D.    +354 5431000    olafurgi@landspitali.is   
Norway
Trondheim University Hospital Recruiting
Trondheim, Norway
Contact: Ann Åsberg, M.D.    + 47 92626432    ann.asberg@ntnu.no   
Sweden
Department of Pediatrics, Drottning Sylvias Pediatric Hospital Recruiting
Gothenburg, Sweden
Contact: Jonas Abrahamson, M.D.    46-707-69-5159    jonas.abrahamsson@vgregion.se   
NOPHO nordic organisation for pediatric onology Recruiting
Stockholm, Sweden
Contact: Mats Heyman, M.D.    +46 706287698    mats.heyman@ki.se   
Contact: Thomas Frandsen, M.D.    +45 3545 8364    t-frandsen@dadlnet.dk   
Principal Investigator: Stefan Söderhäll, M.D.         
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:
No publications provided

Responsible Party: Kjeld Schmiegelow, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00816049     History of Changes
Other Study ID Numbers: NOPHO ALL2008 consolidation
Study First Received: December 23, 2008
Last Updated: May 22, 2012
Health Authority: Denmark: Danish Medicines Agency

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

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

ClinicalTrials.gov processed this record on October 01, 2014