search
Back to results

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

Primary Purpose

Acute Lymphoblastic Leukemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
6MPindividualized
6MPfixed
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring acute lymphoblastic leukemia, child, 6-mercaptopurine, minimal residual disease, efficacy, childhood acute lymphoblastic leukemia

Eligibility Criteria

1 Year - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Pediatrics, Rigshospitalet
  • Helsinki University Hospital
  • University Hospital
  • Trondheim University Hospital
  • Department of Pediatrics, Drottning Sylvias Pediatric Hospital
  • NOPHO nordic organisation for pediatric onology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

6MPfixed

6MPindividualized

Arm Description

Fixed dose 6-mercaptopurine days 30-85

Individualized dose increments of 6-mercaptopurine days 30-85

Outcomes

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)

Secondary Outcome Measures

Toxicity of treatment, degree of myelo-, hepato- and renal toxicity; and development of asparaginase antibodies.

Full Information

First Posted
December 23, 2008
Last Updated
April 20, 2017
Sponsor
Rigshospitalet, Denmark
Collaborators
Nordic Society for Pediatric Hematology and Oncology
search

1. Study Identification

Unique Protocol Identification Number
NCT00816049
Brief Title
ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy
Acronym
ALL2008con
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (Actual)
Primary Completion Date
March 2, 2016 (Actual)
Study Completion Date
March 2, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Nordic Society for Pediatric Hematology and Oncology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia
Keywords
acute lymphoblastic leukemia, child, 6-mercaptopurine, minimal residual disease, efficacy, childhood acute lymphoblastic leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
775 (Actual)

8. Arms, Groups, and Interventions

Arm Title
6MPfixed
Arm Type
Active Comparator
Arm Description
Fixed dose 6-mercaptopurine days 30-85
Arm Title
6MPindividualized
Arm Type
Experimental
Arm Description
Individualized dose increments of 6-mercaptopurine days 30-85
Intervention Type
Drug
Intervention Name(s)
6MPindividualized
Other Intervention Name(s)
PuriNethol, Puri-Nethol (6-mercaptopurine)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
6MPfixed
Other Intervention Name(s)
PuriNethol, Puri-Nethol (6-mercaptopurine)
Intervention Description
Oral 6-mercaptopurine at a fixed dose of 25 mg/m2 treatment days 30-85
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Toxicity of treatment, degree of myelo-, hepato- and renal toxicity; and development of asparaginase antibodies.
Time Frame
6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjeld Schmiegelow, M.D.
Organizational Affiliation
Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Pediatrics, Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Facility Name
University Hospital
City
Reykjavik
Country
Iceland
Facility Name
Trondheim University Hospital
City
Trondheim
Country
Norway
Facility Name
Department of Pediatrics, Drottning Sylvias Pediatric Hospital
City
Gothenburg
Country
Sweden
Facility Name
NOPHO nordic organisation for pediatric onology
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs