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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515499-12-00
Acronym
EsPhALL2017/COGAALL1
Enrollment
306
Registered
2024-10-25
Start date
2017-10-02
Completion date
Unknown
Last updated
2024-11-12

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

Conditions

Acute lymphoblastic leukemia

Brief summary

The primary endpoint, DFS, is defined as the time from randomization to first event (relapse, second malignancy, or death in complete remission) or time to last followup for patients without events, The primary endpoint, DFS, is defined as the time from randomization to first event (relapse, second malignancy, or death in complete remission) or time to last followup for patients without events, The primary endpoint, DFS, is defined as the time from randomization to first event (relapse, second malignancy, or death in complete remission) or time to last followup for patients without events, The primary endpoint, DFS, is defined as the time from randomization to first event (relapse, second malignancy, or death in complete remission) or time to last followup for patients without events

Interventions

DRUGIMATINIB
DRUGDOXORUBICIN HYDROCHLORIDE
DRUGPEGASPARGASE
DRUGCYTARABINE
DRUGDEXAMETHASONE
DRUGDELTACORTENE 25 mg compresse
DRUGMERCAPTOPURINE
DRUGErwinase 10 000 U polvere per soluzione iniettabile/per infusione.
DRUGDAUNORUBICIN HYDROCHLORIDE
DRUGIFOSFAMIDE
DRUGMETHOTREXATE
DRUGCYCLOPHOSPHAMIDE
DRUGETOPOSIDE
DRUGVincristina Teva Italia 1 mg/ml soluzione iniettabile
DRUGDecortin H 5 mg töflur

Sponsors

Universita Degli Studi Di Milano Bicocca
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The primary endpoint, DFS, is defined as the time from randomization to first event (relapse, second malignancy, or death in complete remission) or time to last followup for patients without events, The primary endpoint, DFS, is defined as the time from randomization to first event (relapse, second malignancy, or death in complete remission) or time to last followup for patients without events, The primary endpoint, DFS, is defined as the time from randomization to first event (relapse, second malignancy, or death in complete remission) or time to last followup for patients without events, The primary endpoint, DFS, is defined as the time from randomization to first event (relapse, second malignancy, or death in complete remission) or time to last followup for patients without events

Countries

Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Italy, Netherlands, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026