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Acute Lymphoblastic LeukemiaPhase 2ESPHALLNCT00287105

Safety and Efficacy of Imatinib Added to Chemotherapy in Treatment of Ph+ Acute Lymphoblastic Leukemia in Children

A Phase 2 study testing Standard chemotherapy + Imatinib in people with Acute Lymphoblastic Leukemia and Philadelphia Chromosome, run by Rennes University Hospital at 22 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether Imatinib is safe and effective in association with intensive treatment of Ph+ALL in children. Read more about this study

Who is it for?
Ages 1 year to 18 years
What is being tested?
Standard chemotherapy + Imatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
22 sitesFrance
Study dates
Dec 2005to 3 Mar 2017
Phase
Phase 2
Are there results?
None posted in the registry

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 1 year to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Children and adolescents aged 1 to 17 years at diagnostic
  • Documented Ph+ ALL
  • Eligibility for the current local prospective therapeutic study of childhood ALL
  • Informed consent given by the parents or by legal guardian

Who cannot join

  • Abnormal hepatic functions
  • Abnormal renal functions
  • Active systemic bacterial, fungal or viral infection

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

France22 sites

  • Service d'hématologie pédiatrique CHRU

    Amiens, 80080

  • Service hématologie pédiatrique Hôpital Saint-Jacques

    Besançon, 25000

  • Service d'hémato-oncologie - Hôpital des Enfants Pellegrin

    Bordeaux, 33076

  • Hôpital Morvan

    Brest, 29200

  • Hématologie oncologie pédiatrique-CHU Caen

    Caen

  • Hémato-Oncologie et Thérapie Cellulaire Pédiatrique - Hôtel Dieu

    Clermont-Ferrand, 63058

  • Hémato-Oncologie Pédiatrique - Hôpital d'Enfants

    Dijon, 21034

  • Pédiatrie CHU - Hôpital Nord

    Grenoble, 38043

  • Hôpital Jeanne de Flandre

    Lille, 59037

  • Limoges University Hospital

    Limoges, 87042

  • Hôpital DEBROUSSE Institut d'hématologie et d'oncologie pédiatrique

    Lyon

  • Hôpital Arnaud de Villeneuve

    Montpellier

  • Hématologie Pédiatrique - Hôpital Trousseau

    Paris, 75571

  • Hémato-immunologie-Robert Debré

    Paris

  • Hématologie Hôpital Jean Bernard

    Poitiers, 86021

  • Hématologie pédiatrique-Hopital américain

    Reims

  • Service d'hématologie pédiatrique - Hôpital Sud

    Rennes, 35033

  • Service d'Immuno Hémato Oncologie Pédiatrique - Hôpital Charles Nicolle

    Rouen, 76031

  • Hématologie, Oncologie pédiatrique-CHU Saint Etienne

    Saint-Etienne

  • Hopital des enfants

    Toulouse

  • CHU- Centre Gatien de Clocheville

    Tours, 37044

  • Hôpital d'enfants

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official title: An Open-label, Phase II Study to Explore the Safety and Efficacy of Imatinib With Chemotherapy in Pediatric Patients With Ph+ / BCR-ABL+ Acute Lymphoblastic Leukemia (Ph+ALL)

The purpose of this study is to determine whether Imatinib is safe and effective in association with intensive treatment of Ph+ALL in children.

Read the detailed description

Recent advances in treatment have increased the cure of childhood ALL to 75% or better. However, attempts to improve results for resistant subtypes of ALL, such as Ph+ ALL, have been largely unsuccessful. Imatinib, an inhibitor of protein-tyrosine kinases, is currently being tested in several phase I, II and III trials covering most Chronic Myeloid Leukemia patient populations and patients with overtly relapsed or refractory Ph+ALL. Pediatric patients with Ph+ALL will receive Imatinib, added to intensive, post-induction BFM-type chemotherapy. The endpoint will be the evaluation on the long-term clinical outcome, in particular on the Disease Free Survival (DFS).

Being tested
Standard chemotherapy + Imatinib
Keywords
Chemotherapy, Leukemia, Children, Philadelphia chromosome, Protein-tyrosine kinase inhibitor
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Philadelphia Chromosome, Leukemia

What participants receive

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

  • Standard chemotherapy + ImatinibDrug

    Also called Glivec, Gleevec

    Patients receive Imatinib together with the standard chemotherapy regimen of phase IB and after each of three consecutive blocks of the standard chemotherapy in the consolidation phase

Study groups in NCT00287105
Study groupRoleWhat they receive
Good risk Ph+ALLOtherFor protocols which adopt a steroid prephase: patients who are Prednisone-good responder and achieve CR after the induction course. For protocols which do not adopt steroid prephase: patients who have M1/M2 BM at day 15 or M1 BM at day 21 and achieve CR after the induction course. Expected stratification in this group: 70-75%.
Receives: Drug: Standard chemotherapy + Imatinib
Poor risk Ph+ALLOtherFor protocols which adopt a steroid prephase: patients who are Prednisone poor-responders. For protocol which do not adopt a steroid prephase: patients who have M3 BM at day 15 or M2/M3 BM at day 21. For all protocols: patients who do not achieve CR after the induction course. Expected stratification: 25-30%.
Receives: Drug: Standard chemotherapy + Imatinib

What is being measured

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

  1. Disease free survival (DFS). DFS will be calculated as the time from inclusion to either one of the following events: relapse, death in CCR, second malignancies.

    Measured: 2 years

Secondary outcomes (4)

  1. Compare long term outcome between patients treated by BFM-chemotherapy and patient undergoing more intensive chemotherapy (protocole COGAALL0031 : Children Oncology Group-USA).

    Measured: 2 years

  2. Long-term clinical outcome : Disease free survival (DFS), Event-Free Survival (EFS) and Overall Survival (OS) in each risk groups.

    Measured: 2 years

  3. Pattern of molecular response (MRD)

    Measured: 5 time points between S4 and S22

  4. Conversion rate to CR in patients resistant to the first part of the induction phase of chemotherapy included in the Poor-risk group.

    Measured: 2 years

Timeline

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

  1. First posted6 Feb 2006 (estimated)
  2. Study startDec 2005
  3. Primary completion30 Mar 2016
  4. Study completion3 Mar 2017

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00287105
Sponsor's protocol ID
EUDRACT 2004-001647-30
Other IDs
PHRC/04-04, CIC0203/043
Acronym
ESPHALL
Status last verified
May 2023
First submitted
3 Feb 2006
Last updated
24 May 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Biondi A, Schrappe M, De Lorenzo P, Castor A, Lucchini G, Gandemer V, Pieters R, Stary J, Escherich G, Campbell M, Li CK, Vora A, Arico M, Rottgers S, Saha V, Valsecchi MG. Imatinib after induction for treatment of children and adolescents with Philadelphia-chromosome-positive acute lymphoblastic leukaemia (EsPhALL): a randomised, open-label, intergroup study. Lancet Oncol. 2012 Sep;13(9):936-45. doi: 10.1016/S1470-2045(12)70377-7. Epub 2012 Aug 14.

    PubMed 22898679

  • Biondi A, Gandemer V, De Lorenzo P, Cario G, Campbell M, Castor A, Pieters R, Baruchel A, Vora A, Leoni V, Stary J, Escherich G, Li CK, Cazzaniga G, Cave H, Bradtke J, Conter V, Saha V, Schrappe M, Grazia Valsecchi M. Imatinib treatment of paediatric Philadelphia chromosome-positive acute lymphoblastic leukaemia (EsPhALL2010): a prospective, intergroup, open-label, single-arm clinical trial. Lancet Haematol. 2018 Dec;5(12):e641-e652. doi: 10.1016/S2352-3026(18)30173-X.

    PubMed 30501871

  • Tasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0. No abstract available.

    PubMed 33242441

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Standard chemotherapy + Imatinib in people with Acute Lymphoblastic Leukemia and Philadelphia Chromosome, run by Rennes University Hospital at 22 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Disease free survival (DFS). DFS will be calculated as the time from inclusion to either one of the following events: relapse, death in CCR, second malignancies. (time frame: 2 years). 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 NCT00287105, which also lists 3 linked publications.

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 24 May 2023.

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