Ponatinib for the management of minimal residual disease (MRD) and hematologic relapsein adult Ph+ acute lymphoblastic leukemia (Ph+ ALL) patients.ALL2620

Conditions

Ph+ Acute Lymphoblastic Leukemia

Brief summary

The primary endpoint is the rate of patients who achieve a MRD negativity/MRD reduction following treatment with either Ponatinib alone or in combination with systemic chemotherapy after 3 months of treatment.

Detailed description

Duration of CMR, if applicable., Rate of patients who achieve an hematologic remission in patients treated for an hematologic and extra-hematoloigc relapse and for a refractory disease., The best molecular response achieved during the study., Safety profile in terms of incidence of grade >3 CTC-NCI side effects and toxicities (AE/SAEs)., Mutational analysis in terms of occurrence, type and number of BCR-ABL1 kinase domain mutations., Correlation between the achievement and duration of CMR (or MRD reduction) with the type of fusion protein (e.g. p190 or p210) and the potential occurrence of mutations, as well as with additional genomic lesions, DFS at 24 months., OS at 24 months, CIR at 24 months., Role of clinical and biological assessment at baseline, type of fusion protein (p190 vs p210) and presence of additional genomic lesions and mutations, duration on CMR, OS and DFS.

Related papers

No related papers found yet.

Interventions

DRUGCYTARABINE

DRUGMETHYLPREDNISOLONE

DRUGIclusig 15 mg film-coated tablets

DRUGMETHOTREXATE

DRUGVINCRISTINE

DRUGPONATINIB

DRUGPREDNISONE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the rate of patients who achieve a MRD negativity/MRD reduction following treatment with either Ponatinib alone or in combination with systemic chemotherapy after 3 months of treatment.	—

Secondary

Measure	Time frame
Duration of CMR, if applicable., Rate of patients who achieve an hematologic remission in patients treated for an hematologic and extra-hematoloigc relapse and for a refractory disease., The best molecular response achieved during the study., Safety profile in terms of incidence of grade >3 CTC-NCI side effects and toxicities (AE/SAEs)., Mutational analysis in terms of occurrence, type and number of BCR-ABL1 kinase domain mutations., Correlation between the achievement and duration of CMR (or MRD reduction) with the type of fusion protein (e.g. p190 or p210) and the potential occurrence of mutations, as well as with additional genomic lesions, DFS at 24 months., OS at 24 months, CIR at 24 months., Role of clinical and biological assessment at baseline, type of fusion protein (p190 vs p210) and presence of additional genomic lesions and mutations, duration on CMR, OS and DFS.	—

Measure

Time frame

Duration of CMR, if applicable., Rate of patients who achieve an hematologic remission in patients treated for an hematologic and extra-hematoloigc relapse and for a refractory disease., The best molecular response achieved during the study., Safety profile in terms of incidence of grade >3 CTC-NCI side effects and toxicities (AE/SAEs)., Mutational analysis in terms of occurrence, type and number of BCR-ABL1 kinase domain mutations., Correlation between the achievement and duration of CMR (or MRD reduction) with the type of fusion protein (e.g. p190 or p210) and the potential occurrence of mutations, as well as with additional genomic lesions, DFS at 24 months., OS at 24 months, CIR at 24 months., Role of clinical and biological assessment at baseline, type of fusion protein (p190 vs p210) and presence of additional genomic lesions and mutations, duration on CMR, OS and DFS.

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Countries

Italy

Outcome results

None listed