ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia Intermittent Versus Continuous PEG Asparaginase

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-01

Study Completion Date

2016-03-02

Brief Summary

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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

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Detailed Description

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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

Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PEG-asparaginase 6 weeks intervals

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.

Group Type EXPERIMENTAL

PEG Asparaginase at six weeks interval

Intervention Type DRUG

PEG-asparaginase (1.000 IU/m2/dose) given at six weeks intervals (until the patient has received 33 weeks of therapy)

PEG-Asparaginase 2 weeks intervals

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.

Group Type ACTIVE_COMPARATOR

PEG Asparaginase at two weeks interval

Intervention Type DRUG

PEG-asparaginase (1.000 IU/m2/dose) given at two weeks intervals (until the patient has received 33 weeks of therapy)

Interventions

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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)

Intervention Type 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)

Intervention Type DRUG

Other Intervention Names

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Oncaspar (PEG-Asparaginase) Oncaspar (PEG-Asparaginase)

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No