A PRECISION MEDICINE RANDOMIZED TRIAL FOR PATIENTS WITH RELAPSED OR REFRACTORY T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA BASED ON A FUNCTIONAL APPROACH. ALL-TARGET TRIAL

Conditions

Relapsed/refractory T-cell Acute Lymphoblastic Leukemia

Brief summary

Hematological remission rate, which is a composite outcome (CRc), defined as the best response observed within 3 months post randomization, either complete remission (CR) or remission without complete hematological recovery (CRi).

Detailed description

1. Hematological response rate (HR) defined as complete remission (CR), remission without complete hematological recovery (CRi) and partial response (PR) by 3 months post randomization., 2. Overall survival, defined as the time from randomization up to death, whatever the cause, 3. Stable disease by 3 months, 4. Duration of response, 5. Event free survival, defined as the time from randomization up to relapse or death, whichever occurred first, 6. Relapse free survival, defined as the time from response up to relapse or death, 7. Adverse events and cumulative incidence of adverse events (treatment duration + 1 mois), 8. Response per treatment combination by 3 and 6 months, 9. Bridge to transplant, bridge to CART-cell, 10. Minimal residual disease at 3 months in responding patients, 11. Quality of life (HM-PRO & HADS) questionnaires monthly up to 3 months, 12. Mechanisms of resistance to therapies, 13. Post-hoc analysis of TTO allocation

Related papers

No related papers found yet.

Interventions

DRUGVenetoclax

DRUGEnrylaze 10 mg/0.5mL

DRUGsolution for injection/infusion

DRUGXELJANZ 5 mg film-coated tablets

DRUGAzacitidine Mylan 25 mg/mL powder for suspension for injection

DRUGAfinitor 5 mg tablets

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Hematological remission rate, which is a composite outcome (CRc), defined as the best response observed within 3 months post randomization, either complete remission (CR) or remission without complete hematological recovery (CRi).	—

Secondary

Measure	Time frame
1. Hematological response rate (HR) defined as complete remission (CR), remission without complete hematological recovery (CRi) and partial response (PR) by 3 months post randomization., 2. Overall survival, defined as the time from randomization up to death, whatever the cause, 3. Stable disease by 3 months, 4. Duration of response, 5. Event free survival, defined as the time from randomization up to relapse or death, whichever occurred first, 6. Relapse free survival, defined as the time from response up to relapse or death, 7. Adverse events and cumulative incidence of adverse events (treatment duration + 1 mois), 8. Response per treatment combination by 3 and 6 months, 9. Bridge to transplant, bridge to CART-cell, 10. Minimal residual disease at 3 months in responding patients, 11. Quality of life (HM-PRO & HADS) questionnaires monthly up to 3 months, 12. Mechanisms of resistance to therapies, 13. Post-hoc analysis of TTO allocation	—

Measure

Time frame

1. Hematological response rate (HR) defined as complete remission (CR), remission without complete hematological recovery (CRi) and partial response (PR) by 3 months post randomization., 2. Overall survival, defined as the time from randomization up to death, whatever the cause, 3. Stable disease by 3 months, 4. Duration of response, 5. Event free survival, defined as the time from randomization up to relapse or death, whichever occurred first, 6. Relapse free survival, defined as the time from response up to relapse or death, 7. Adverse events and cumulative incidence of adverse events (treatment duration + 1 mois), 8. Response per treatment combination by 3 and 6 months, 9. Bridge to transplant, bridge to CART-cell, 10. Minimal residual disease at 3 months in responding patients, 11. Quality of life (HM-PRO & HADS) questionnaires monthly up to 3 months, 12. Mechanisms of resistance to therapies, 13. Post-hoc analysis of TTO allocation

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Outcome results

None listed