ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia Intermittent Versus Continuous PEG Asparaginase
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Purpose
The purpose of this study is to investigate if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of Event Free Survival
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Lymphoblastic Leukemia |
Drug: PEG Asparaginase at six weeks interval Drug: PEG Asparaginase at two weeks interval |
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: | NOPHO Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults(18.0-45.0 Years) With Acute Lymphoblastic Leukemia. Intermittent Versus Continuous PEG-asparaginase for Asparagine Depletion |
- Event Free Survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- Secondary Outcome Measures are toxicity (special focus on thrombosis, pancreatitis, and allergic reactions), the formation of silent antibodies, and the influence of antibody production on the EFS. [ Time Frame: 6 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 2
PEG-asparaginase (1.000 IU/m2/dose) given at six weeks intervals (from week 13 after diagnosis to week 33). All additional therapy (High Dose Methotrexate, Vincristin, Dexamethasone, 6-Mercaptopurine, doxorubicin, intrathecal chemotherapy) is the same in both arms. |
Drug: PEG Asparaginase at six weeks interval
PEG-asparaginase (1.000 IU/m2/dose) given at six weeks intervals (until the patient has received 33 weeks of therapy)
Other Name: Oncaspar (PEG-Asparaginase)
|
|
Active Comparator: 1
PEG-asparaginase (1.000 IU/m2/dose) given at two weeks intervals (from week 13 after diagnosis to week 33). All additional therapy (High Dose Methotrexate, Vincristin, Dexamethasone, 6-Mercaptopurine, doxorubicin, intrathecal chemotherapy) is the same in both arms. |
Drug: PEG Asparaginase at two weeks interval
PEG-asparaginase (1.000 IU/m2/dose) given at two weeks intervals (until the patient has received 33 weeks of therapy)
Other Name: Oncaspar (PEG-Asparaginase)
|
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 test if intramuscular PEG-asparaginase administered either at six or two week intervals from day 92 until 8 months from diagnosis for patients with non-HR ALL will result in equal probability of EFS. As secondary endpoints asparaginase antibody production and toxicity including allergic reactions in the treatment-arms will be analysed
Eligibility| Ages Eligible for Study: | 1 Year to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Childhood ALL
- All mandatory biological data are available6
- Written informed consent has been obtained
Exclusion Criteria:
- Bilineage 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
- No allergic reactions to PEG Asparaginase
Contacts and Locations| Contact: Kjeld Schmiegelow, M.D. | +45 35451357 | kschmiegelow@rh.regionh.dk |
| Contact: Thomas Frandsen, M.D. | +45 35458364 | thomas.leth.frandsen@rh.regionh.dk |
| Denmark | |
| Department of Pediatrics, Rigshospitalet | Recruiting |
| Copenhagen, Denmark, 2100 | |
| Contact: Kjeld Schmiegelow, M.D. +4535451357 kschmiegelow@rh.regionh.dk | |
| Contact: Thomas Frandsen, M.D. +4535458364 thomas.leth.frandsen@rh.regionh.dk | |
| Finland | |
| Helsinki University Hospital | Recruiting |
| Helsinki, Finland | |
| Contact: Kim Vettenranta, M.D. + 35 850-3676528 kim.vettenranta@hus.fi | |
| Iceland | |
| University Hospital Reykjavik, Iceland | 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. | |
| 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: | NCT00819351 History of Changes |
| Other Study ID Numbers: | NOPHO ALL2008 PEG Asparaginase |
| Study First Received: | January 8, 2009 |
| Last Updated: | May 22, 2012 |
| Health Authority: | Denmark: Danish Medicines Agency |
Keywords provided by Rigshospitalet, Denmark:
|
acute lymphoblastic leukemia child PEG-Asparaginase |
EFS 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 Pegaspargase Asparaginase Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013