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Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia


Phase 3
1 Year
18 Years
Not Enrolling
Both
Acute Lymphoblastic Leukemia

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Trial Information

Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia


Inclusion Criteria:



- Previously untreated T-lineage or precursor B-lineage ALL

- Patients must have morphological proof of ALL and diagnosis must be made from bone
marrow morphology with more than 25% blasts

- Written informed consent

- Treatment according to DCOG ALL 10 protocol

Exclusion Criteria:

- Mature B-lineage ALL

- Patients with secondary ALL

- Known allergy to any ASNase preparation

- General health status according to Karnofsky / Lansky score < 40%

- Pre-existing known coagulopathy (e.g. haemophilia)

- Pre-existing pancreatitis

- Liver insufficiency (Bilirubin > 50 µmol/L; SGOT/SGPT > 10 x ULN)

- Other current malignancies

- Pregnancy (planned or existent), breast feeding

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

To determine the rate of patients with complete asparagine (ASN) depletion in serum during induction treatment and to demonstrate non-inferiority of rASNase compared to Asparaginase medac™ with respect to this parameter

Outcome Time Frame:

March 2012

Safety Issue:

No

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

MC-ASP.5/ALL

NCT ID:

NCT00784017

Start Date:

October 2008

Completion Date:

October 2012

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Children with previously untreated acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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