ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy - Full Text View

Sponsor:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00816049

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 III

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:

MedlinePlus related topics: Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: 6-Mercaptopurine Mercaptopurine

U.S. FDA Resources

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

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

Investigators

Study Chair:

Kjeld Schmiegelow, M.D.

Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen

More Information

Additional Information:

Home page of NOPHO - most areas are closed This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Kjeld Schmiegelow, University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen
ClinicalTrials.gov Identifier:	NCT00816049 History of Changes
Other Study ID Numbers:	NOPHO ALL2008 consolidation
Study First Received:	December 23, 2008
Last Updated:	June 1, 2010
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:

Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
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 February 09, 2012