Eine internationale Phase 3 Studie für Philadelphia Chromosom-positive akute lymphoblastische Leukämie (Ph+ ALL), die Imatinib in Kombination mit zwei verschiedenen zytotoxischen Chemotherapien untersucht.

Punti finali secondari (Fonte di dati: WHO)

Secondary end point(s): 1. To compare disease free survival (DFS) of SR pediatric Ph+ and ABLclass
fusion positive patients treated with continuous imatinib combined
with either a high-risk COG-ALL chemotherapy backbone or the more
intensive EsPhALL chemotherapy backbone. The DFS is defined as the
time from randomization to first event (relapse, second malignancy, or
death in complete remission) or time to last follow-up for patients
without events. DFS comparison will be done according to the intention
to treat (ITT) principle by assigned arm. Since only limited data will be
available for ABL-class fusion positive patients, applicability of the
pooled analysis to this subgroup is questionable. A separate analysis for
the ABL-class fusion positive patients is therefore planned as exploratory
aim.
2. To determine the feasibility of administration of imatinib after
allogeneic HSCT in HR Ph+ ALL patients.
3. To determine event free survival (EFS) of HR pediatric Ph+ ALL
patients treated with EsPhALL chemotherapy, HSCT in first complete
remission and post-HSCT imatinib. EFS is defined as the time from the
date of bone marrow for MRD assessment at end-IB to first event
(resistant disease [i.e. MRD=10^-2 or morphologic residual disease at
end of Consolidation Block 3], relapse, progressive disease [i.e. MRD =
10^-2 at two post-HSCT time points separated by at least 2 weeks
obtained at Day 90 or later from HSCT], second malignancy, or death in
complete remission) or time to last follow-up for patients without
events.
4. To compare rates of Grade 3 or higher infections in Standard Risk Ph+
ALL patients between the two randomized arms.
5. To evaluate EFS and overall survival (OS) of all eligible Ph+ ALL
patients enrolled on the study.
6. To evaluate OS in SR Ph+ ALL patients. OS as secondary endpoint is
defined as the time from randomization to death from any cause.
7. To evaluate OS (defined as time from MRD assessment at end-IB to
death from any cause) in HR Ph+ ALL.
8. To evaluate EFS and OS of all eligible ABL-class fusion positive ALL
patients enrolled on the study.;Timepoint(s) of evaluation of this end point: 1.From day +56 to +365
2.from the date of bone marrow for MRD assessment at end-IB to first event or time to last follow-up for patients without events.
3.From the end of IB to the start of Manteinance
4.EFS: from enrollment until the first occurrence of M3 marrow at the end of Induction IA, relapse, second malignancy, or death as a first event); OS: from the time from study enrollment to death from any cause.
5.From enrollment to death from any cause.
6.From MRD assessment at end-IB to death from any cause.