A multicentre, randomized trial in adults with de novo Philadelphia-Chromosome positive acute lymphoblastic leukemia to assess the efficacy of ponatinib versus imatinib in combination with low-intensity chemotherapy, to compare end of therapy with indication for SCT versus TKI, blinatumomab and chemotherapy in optimal responders and to evaluate blinatumomab in suboptimal responders (GMALL-EVOLVE)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517966-40-00

Enrollment

208

Registered

2024-11-08

Start date

2023-07-13

Completion date

Unknown

Last updated

2026-01-08

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

Conditions

Acute lymphoblastic leukemia (ALL), de novo, Ph/BCR::ABL1 positive (Ph+)

Brief summary

Probability of overall survival at 2,3 and 4 years from randomization I in patients with mo- lecular remission after consolidation 1 comparing a combination treatment of TKI, Blina- tumomab and chemotherapy versus EOT with indication for SCT

Detailed description

Rate of molecular complete remission at week 11 after consolidation with chemotherapy in combination with Ponatinb versus Imatinib

Interventions

DRUGBLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.

DRUGIMATINIB

DRUGIclusig 45 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Probability of overall survival at 2,3 and 4 years from randomization I in patients with mo- lecular remission after consolidation 1 comparing a combination treatment of TKI, Blina- tumomab and chemotherapy versus EOT with indication for SCT	—

Secondary

Measure	Time frame
Rate of molecular complete remission at week 11 after consolidation with chemotherapy in combination with Ponatinb versus Imatinib	—

Countries

Germany

Outcome results

None listed

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