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Acute Lymphoblastic LeukemiaPhase 3CAALL-F01NCT02716233

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

A Phase 3 study testing pegaspargase 1250 IU/m2 x 2 and pegaspargase 2500 IU/m2 x 1 in people with Acute Lymphoblastic Leukemia, run by Assistance Publique - Hôpitaux de Paris at 28 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 12 months to 18 years
Conditions the study is for
Acute Lymphoblastic Leukemia
What is being tested?
pegaspargase 1250 IU/m2 x 2 and pegaspargase 2500 IU/m2 x 1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,044 participants
Where
28 sitesFrance
Study dates
19 Sep 2016to Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 months to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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)
Show all 11Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

France28 sites

  • CHU

    Amiens, 80054

  • CHU

    Angers, 49033

  • CHRU

    Besançon, 25030

  • CHU

    Bordeaux, 33076

  • CHU

    Brest, 29609

  • CHU

    Caen, 14033

  • CHU

    Clermont-Ferrand, 63003

  • CHU

    Dijon, 21079

  • CHU

    Grenoble, 38043

  • CHU

    Lille, 59037

  • CHU

    Limoges, 87042

  • Chu-Ihope

    Lyon, 69373

  • CHU

    Marseille, 13385

  • CHU

    Montpellier, 34295

  • CHU

    Nancy, 54511

  • CHU

    Nantes, 44093

  • CHU

    Nice, 06200

  • CHU Saint Louis

    Paris, 75010

  • CHU Armand Trousseau

    Paris, 75012

  • CHU Robert Debré

    Paris, 75019

  • CHU

    Poitiers, 86000

  • CHU

    Reims, 51100

  • CHU

    Rennes, 35203

  • CHU

    Rouen, 76031

  • CHU

    Saint-Etienne, 42270

  • CHU

    Strasbourg, 67098

  • CHU

    Toulouse, 31059

  • CHU

    Tours, 37044

Other trials in France

About this study

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).

Read more

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.
Being tested
pegaspargase 1250 IU/m2 x 2, pegaspargase 2500 IU/m2 x 1
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pegaspargase 1250 IU/m2 x 2Drug

    Also called ONCASPAR 1250 IU/m2 x 2

    only for ALL of standard risk and medium risk

  • pegaspargase 2500 IU/m2 x 1Drug

    Also called ONCASPAR 2500 IU/m2 x 1

    only for ALL of standard risk and medium risk

Study groups in NCT02716233
Study groupRoleWhat they receive
Arm 1Active comparatorpegaspargase 2500 IU/m2 x 1: infusion of a conventional dose of pegaspargase during induction therapy: 2500 IU/m2x1
Receives: Drug: pegaspargase 2500 IU/m2 x 1
Arm 2Experimentalpegaspargase 1250 IU/m2 x 2: fractionation of the 2500 IU/m2 pegaspargase dose in two infusions of 1250 IU/m2 each during delayed intensification
Receives: Drug: pegaspargase 1250 IU/m2 x 2

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    asparaginase activity > 100 IU/L

    Measured: Day 33

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

    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

    Measured: Between Day 12 of induction and Day 8 of consolidation

Secondary outcomes (13)

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

    Measured: Day 33 of induction

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

    Measured: 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

    Measured: Day 40 of induction

  4. Incidence of antibodies against asparaginase, measured in serum

    Measured: Day 4 of delayed intensification

  5. Incidence of silent inactivation

    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

    Measured: First 6-9 months

  6. Percentage of patients without switch to Erwinia asparaginase

    Measured: First 6-9 months

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

    Measured: First 6-9 months

  8. Morphological Complete Remission (CR) rates

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

    Measured: Day 35-Day 42

  9. Minimal Residual Disease (MRD)

    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).

    Measured: Day 35-Day 42, Day 65-Day 105

  10. Cumulative Incidence of relapses

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

    Measured: 5 years

  11. Cumulative Incidence of relapse according to site of relapse

    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).

    Measured: 5 years

  12. All other adverse events related to asparaginase

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

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

  13. Late adverse events related to asparaginase

    Measured: after Day 49 of induction or anyway at Day 8 of consolidation or after

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2016 (estimated)
  2. Study start19 Sep 2016
  3. Primary completionApr 2022
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,044 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02716233
Sponsor's protocol ID
P091205
Acronym
CAALL-F01
Status last verified
May 2024
First submitted
15 Feb 2016
Last updated
16 Sep 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pegaspargase 1250 IU/m2 x 2 and pegaspargase 2500 IU/m2 x 1 in people with Acute Lymphoblastic Leukemia, run by Assistance Publique - Hôpitaux de Paris at 28 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adequate (> 100 IU/L) asparaginase activity measured in the plasma at day 33 of induction therapy (time frame: Day 33). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02716233.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.

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