International trial in Philadelphia chromosome-positive acute lymphoblastic leukemia

International phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones - EsPhALL2017/COGAALL1631

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000705-20-AT

Enrollment

700

Registered

2017-10-30

Start date

2017-12-11

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Philadelphia positive Acute Lumphoblastic Leukemia MedDRA version: 21.0 Level: PT Classification code 10034877 Term: Philadelphia chromosome positive System Organ Class: 10022891 - Investigations MedDRA version: 21.0 Level: LLT Classification code 10000844 Term: Acute lymphoblastic leukaemia System Organ Class: 100000004864

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: DEXAMETHASONE Current Sponsor code: DEX Pharmaceutical Form: Solution for injection INN or Proposed INN: DEXAMETHASONE Current Sponsor code: DEX Phar

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients should be enrolled on National ALL protocol prior to enrollment on EsPhALL2017/COGAALL1631. Regardless of initial frontline protocol baseline diagnostic samples must be available to develop an MRD probe. Diagnostic samples will be collected and analyzed according to the procedures of the National front-line protocol. 2. > 1 year and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Known history of chronic myelogenous leukemia (CML). 2. ALL developing after a previous cancer treated with cytotoxic chemotherapy. 3. Active, uncontrolled infection or active systemic illness that requires ongoing vasopressor support or mechanical ventilation 4. Down syndrome 5. Pregnancy 6. Breast Feeding 7. Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of treatment according to protocol. 8. Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block. 9. Prior treatment with dasatinib, or any TKI inhibitor other than imatinib.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare disease-free survival (DFS) of Standard Risk (SR) Ph+ ALL patients treated with continuous imatinib combined with either the EsPhALL chemotherapy backbone (Arm A) or a less intensive a high-risk COG ALL chemotherapy backbone (Arm B), according to the randomization result. A non-inferiority design will be applied in order to evaluate whether there is significant erosion in DFS in SR patients treated with the less intensive Arm B compared with Arm A.;Secondary Objective: 1. To compare disease free survival (DFS) of SR pediatric Ph+ and ABLclass fusion positive ALL patients treated with continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone. To determine the feasibility of administration of imatinib after allogeneic HSCT in High Risk (HR) Ph+ ALL patients. 2. 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. 3. To compare rates of Grade 3 or higher infections in SR Ph+ ALL patients between the two randomized arms. 4. To evaluate EFS and overall survival (OS) of all eligible Ph+ALL patients enrolled on the study. 5. To evaluate OS in SR Ph+ ALL patients. 6. To evaluate OS in HR Ph+ ALL patients. 7. To evaluate EFS and OS of all eligible ABL-class fusion positive ALL patients enrolled on the study. ;Primary end point(s): DFS, 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.;Timepoint(s) of evaluation of this end point: from randomization to first event (relapse, second malignancy, or death in complete remission) or time to last follow-up for patients without events.	—

Measure

Time frame

Main Objective: To compare disease-free survival (DFS) of Standard Risk (SR) Ph+ ALL patients treated with continuous imatinib combined with either the EsPhALL chemotherapy backbone (Arm A) or a less intensive a high-risk COG ALL chemotherapy backbone (Arm B), according to the randomization result. A non-inferiority design will be applied in order to evaluate whether there is significant erosion in DFS in SR patients treated with the less intensive Arm B compared with Arm A.;Secondary Objective: 1. To compare disease free survival (DFS) of SR pediatric Ph+ and ABLclass fusion positive ALL patients treated with continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone. To determine the feasibility of administration of imatinib after allogeneic HSCT in High Risk (HR) Ph+ ALL patients. 2. 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. 3. To compare rates of Grade 3 or higher infections in SR Ph+ ALL patients between the two randomized arms. 4. To evaluate EFS and overall survival (OS) of all eligible Ph+ALL patients enrolled on the study. 5. To evaluate OS in SR Ph+ ALL patients. 6. To evaluate OS in HR Ph+ ALL patients. 7. To evaluate EFS and OS of all eligible ABL-class fusion positive ALL patients enrolled on the study. ;Primary end point(s): DFS, 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.;Timepoint(s) of evaluation of this end point: from randomization to first event (relapse, second malignancy, or death in complete remission) or time to last follow-up for patients without events.

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Secondary

Measure	Time frame
Secondary end point(s): 1. To compare disease free survival (DFS) of SR pediatric Ph+ and ABL-class 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 ti	—

Measure

Time frame

Secondary end point(s): 1. To compare disease free survival (DFS) of SR pediatric Ph+ and ABL-class 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 ti

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Countries

Australia, Austria, Belgium, Canada, Chile, Czechia, Czech Republic, Denmark, European Union, Finland, France, Germany, Hong Kong, Israel, Italy, Netherlands, Poland, Sweden, Switzerland, United Kingdom, United States

Contacts

Public ContactCoordinamento Ricerca Clinica

Università degli Studi Milano Bicocca

dastoli.giuseppe@gmail.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026