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NCT00287105 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2023-05-24

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Abnormal hepatic functions * Abnormal renal functions * Active systemic bacterial, fungal or viral infection
healthy Volunteers
false
maximum Age
18 Years
minimum Age
1 Year
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    For 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%.
    intervention Names
    1. Drug: Standard chemotherapy + Imatinib
    label
    Good risk Ph+ALL
    type
    OTHER
  2. description
    For 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%.
    intervention Names
    1. Drug: Standard chemotherapy + Imatinib
    label
    Poor risk Ph+ALL
    type
    OTHER
interventions
  1. arm Group Labels
    1. Good risk Ph+ALL
    2. Poor risk Ph+ALL
    description
    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
    name
    Standard chemotherapy + Imatinib
    other Names
    1. Glivec
    2. Gleevec
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
49
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. 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
secondary Outcomes
  1. measure
    Compare long term outcome between patients treated by BFM-chemotherapy and patient undergoing more intensive chemotherapy (protocole COGAALL0031 : Children Oncology Group-USA).
    time Frame
    2 years
  2. measure
    Long-term clinical outcome : Disease free survival (DFS), Event-Free Survival (EFS) and Overall Survival (OS) in each risk groups.
    time Frame
    2 years
  3. measure
    Pattern of molecular response (MRD)
    time Frame
    5 time points between S4 and S22
  4. measure
    Conversion rate to CR in patients resistant to the first part of the induction phase of chemotherapy included in the Poor-risk group.
    time Frame
    2 years
Full study description
brief 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.
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).
Source references
references
  1. citation
    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.
    pmid
    22898679
    type
    RESULT
  2. citation
    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.
    pmid
    30501871
    type
    RESULT
  3. citation
    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.
    pmid
    33242441
    type
    DERIVED
see Also Links
Source notices and limitations
    Discovery and provenance
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      occurrences
      1. context exact
        tinib and 56% for patients who did not receive imatinib).[<a href="#cit/section_9.107">107</a>]</li></ul></div></li><li>The subsequent <a href="/clinicaltrials/NCT00287105">EsPhALL2010 (NCT00287105)</a> trial was a result of an amendment to the 2004 trial, which included earlier initiation of imatinib therapy at day 15 of inducti
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        who did not receive imatinib).[<a href="#cit/section_9.107">107</a>]</li></ul></div></li><li>The subsequent <a href="/clinicaltrials/NCT00287105">EsPhALL2010 (NCT00287105)</a> trial was a result of an amendment to the 2004 trial, which included earlier initiation of imatinib therapy at day 15 of induction and continuous dosing o
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      source retrieved at
      2026-09-09T23:21:53.377184+00:00
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      source string sha256
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      source title
      Childhood Acute Lymphoblastic Leukemia Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 21, 2025
        datetime
        2025-04-21T12:00:00Z
        display
        April 21, 2025

    Preserved source evidence · Not medical advice