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NCT Number: NCT02716233

A French Protocol for the Treatment of Acute Lymphoblastic Leukemia (ALL) in Children and Adolescents

A still major question in the field of acute lymphoblastic leukemia (ALL) in children - an extremely heterogeneous disease though curable in 80-90% of children and 70-80% of the adolescents - is the optimal use of L-asparaginase (ASNase). It is known that administering ASNase results in the depletion of asparagine circulating in the blood, which starves the leukemic cells and results in their death. But indeed the use of ASNase varies between protocols considering the different brands, the dose and the administration modalities. Oncaspar (PEGylated E. coli asparaginase, pegaspargase) was thus developed with the goal of reducing the immunogenicity of the native ASNase.

This is a French prospective multicentric cohort study of children and adolescents with ALL, stratified on (i) the type of ALL ( B vs T) and (ii) the anticipated risk (stratified in 3 groups for childhood B-cell precursor (BCP)-ALL and 2 groups for T-cell ALL).

It aims to answer to two different issues:

1. Randomized question: what is the best way to administer pegaspargase? A cohort of children and adolescents with standard or medium risk ALL will be randomized to receive during induction either one infusion of ONCASPAR® 2500 IU/m2 at D12 or two infusions of ONCASPAR® at 1250 IU/m2 each at D12 and D26. Patients will then receive 2500 IU/m2 or 1250 IU/m2 per dose during consolidation and delayed intensification according to the initial arm of randomization. 2. Non randomized question: In the High/Very High Risk groups, a non randomized intensification of the scheme of asparaginase administration is proposed during induction therapy: 2 infusions of 2500 IU/m2/day (D12 and D26) will be administered. All patients will receive 2500 IU/m2 per dose during consolidation and delayed intensifications.

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

12 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children and adolescents Age > 12 months but < 18 yearsB-lineage or T- lineage ALL
  • Written informed consent obtained before day 8 of treatment

Non inclusion criteria:

  • L3 (Burkitt's leukemia) (LMB type protocols)
  • Mixed Phenotype Acute Leukemia (WHO criteria).
  • Infant ALL (age ≤ 365 days (Interfant 06 protocol)
  • Secondary leukemia
  • Patients previously treated with chemotherapy (steroid exposed patients can be included and stratified according to Section 3.5) Known allergy to pegylated products
  • Pregnancy. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant must have a negative serum pregnancy before inclusion and a reliable contraception except oral contraceptives. The contraception should be maintained throughout the study and for 3 months after treatment discontinuation.
  • Known HIV positivity
  • CNS thrombosis during Prophase

Exclusion criteria

  • Ph+/BCR-ABL ALL (ESPhALL protocol)
  • CNS thrombosis before D12

Treatment and study plan

pegaspargase 1250 IU/m2 x 2

Drug

only for ALL of standard risk and medium risk

Other names: ONCASPAR 1250 IU/m2 x 2

pegaspargase 2500 IU/m2 x 1

Drug

only for ALL of standard risk and medium risk

Other names: ONCASPAR 2500 IU/m2 x 1

Primary outcomes

  1. Incidence of adequate (> 100 IU/L) asparaginase activity measured in the plasma at day 33 of induction therapy

    Time frame: Day 33

    asparaginase activity > 100 IU/L

  2. Incidence of directly asparaginase-related severe toxicities (Grade ≥ 3 as assessed by CTCAE v4.0) observed during induction therapy

    Time frame: Between Day 12 of induction and Day 8 of consolidation

    Incidence of severe toxicities (Grade ≥ 3) directly asparaginase-related (CNS thrombosis, pancreatitis, anaphylaxis, and hyperbilirubinemia) between Day 12 and Day 49 of treatment and anyway before Day 8 of consolidation

Secondary outcomes

  1. Incidence of asparagine depletion measured in plasma by a concentration below the Limit of Quantification (LOQ) of 0.4 micromol/L

    Time frame: Day 33 of induction

  2. Incidence of adequate (> 100 IU/L) asparaginase activity measured in the plasma at day 40 of induction therapy

    Time frame: Day 40 of induction

  3. Incidence of asparagine depletion measured in plasma by a concentration below the Limit of Quantification (LOQ) of 0.4 micromol/L

    Time frame: Day 40 of induction

  4. Incidence of antibodies against asparaginase, measured in serum

    Time frame: Day 4 of delayed intensification

  5. Incidence of silent inactivation

    Time frame: First 6-9 months

    Silent inactivation or subclinical hypersensitivity is defined as a plasma PEGasparaginase activity level <100 IU/L at day 7+/- 1 or <20 IU/L at day 14 +/- 11 after administration in a patient without clinical symptoms of allergy

  6. Percentage of patients without switch to Erwinia asparaginase

    Time frame: First 6-9 months

  7. Percentage of patients receiving more than 95% of the intended dose of asparaginase

    Time frame: First 6-9 months

  8. Morphological Complete Remission (CR) rates

    Time frame: Day 35-Day 42

    Assessed on the whole population or on subgroups (B-Lineage ALL, T-cell ALL).

  9. Minimal Residual Disease (MRD)

    Time frame: Day 35-Day 42, Day 65-Day 105

    MRD will be assessed by Ig/T cell receptor (TCR)-based real-time quantitative (RQ)-polymerase chain reaction (PCR), assessed on the whole population or on subgroups (B-Lineage ALL, T-cell ALL).

    Assessed on the whole population or on subgroups (B-Lineage ALL, T-cell ALL).

  10. Cumulative Incidence of relapses

    Time frame: 5 years

    Assessed on the whole population or on subgroups (B-Lineage ALL, T-cell ALL).

  11. Cumulative Incidence of relapse according to site of relapse

    Time frame: 5 years

    Bone-Marrow (BM) relapses, central nervous system (CNS) relapses, gonadal relapses, combined relapses.

    Assessed on the whole population or on subgroups (B-Lineage ALL, T-cell ALL).

  12. All other adverse events related to asparaginase

    Time frame: within the first 7 weeks (Day 49) of treatment and anyway before Day 8 of consolidation

    Drug-induced hyperglycemia or diabetes, coagulopathy, allergy Non CNS thrombosis Grade 1-2 Adverse Events (AE): pancreatitis, hyperbilirubinemia

  13. Late adverse events related to asparaginase

    Time frame: after Day 49 of induction or anyway at Day 8 of consolidation or after

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Shire

Registry information

Acronym: CAALL-F01

Important dates

Study start
2016
Primary completion
2022
Study completion
2027
First posted
Mar 23, 2016
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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