Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL.

Conditions

Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL

Brief summary

R1 Sub-Study: The primary endpoint is Event Free Survival (EFS) at year 4. EFS is defined as the time from randomization (intention-to-treat analysis) or HSCT (per-protocol/as treated) to first failure event defined as follows: Failure events are: • Relapse • Death from any cause • Diagnosis of a second malignant neoplasm Patients without event will be censored at last follow-up date., R2 Sub-Study: • Overall response rate (ORR) at Day 28 after randomization, defined as the proportion of patients in each arm demonstrating a complete response (CR) or partial response (PR) without requirement for additional systemic therapies for earlier progression, mixed response or nonresponse. Scoring of response will be relative to the organ stage at the time of randomization., S1 Sub-Study: EFS is defined as the time from HSCT to first failure event defined as follows: Failure events are: - Relapse - Graft failure - Death from any cause - Diagnosis of a second malignant neoplasm Patients without event will be censored at last follow-up date., P1 Sub-Study: Compare the CIR 2 years after HSCT in blinatumomab-treated patents and historical controls. CIR is calculated from the time of study enrolment until the date of relapse (defined as either bone marrow aspirate or biopsy with ≥ 5% blasts or as appearance of leukemia cells in an extramedullary site) or last follow-up (death from any cause other than leukemia relapse will be considered a competing event).

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Interventions

DRUGGrafalon 20 mg/ml concentrate for solution for infusion.

DRUGJakavi 5 mg/ml oral solution

DRUGBusulfan Tillomed 6 mg/ml concentrate for solution for infusion

DRUGETOPOSIDE TEVA 100 mg/5 ml

DRUGsolution injectable pour perfusion

DRUGMETHYLPREDNISOLONE

DRUGCyclophosphamide 500 mg Powder for Solution for Injection or Infusion

DRUGThymoglobuline 25 mg powder for solution for infusion.

DRUGTrecondi 1 g powder for solution for infusion

DRUGJakavi 5 mg tablets

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

DRUGThiotepa Riemser 100 mg powder for concentrate for solution for infusion

DRUGFludarabine 50mg Powder For Solution For Injection Or Infusion

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
R1 Sub-Study: The primary endpoint is Event Free Survival (EFS) at year 4. EFS is defined as the time from randomization (intention-to-treat analysis) or HSCT (per-protocol/as treated) to first failure event defined as follows: Failure events are: • Relapse • Death from any cause • Diagnosis of a second malignant neoplasm Patients without event will be censored at last follow-up date., R2 Sub-Study: • Overall response rate (ORR) at Day 28 after randomization, defined as the proportion of patients in each arm demonstrating a complete response (CR) or partial response (PR) without requirement for additional systemic therapies for earlier progression, mixed response or nonresponse. Scoring of response will be relative to the organ stage at the time of randomization., S1 Sub-Study: EFS is defined as the time from HSCT to first failure event defined as follows: Failure events are: - Relapse - Graft failure - Death from any cause - Diagnosis of a second malignant neoplasm Patients withou	—

Measure

Time frame

R1 Sub-Study: The primary endpoint is Event Free Survival (EFS) at year 4. EFS is defined as the time from randomization (intention-to-treat analysis) or HSCT (per-protocol/as treated) to first failure event defined as follows: Failure events are: • Relapse • Death from any cause • Diagnosis of a second malignant neoplasm Patients without event will be censored at last follow-up date., R2 Sub-Study: • Overall response rate (ORR) at Day 28 after randomization, defined as the proportion of patients in each arm demonstrating a complete response (CR) or partial response (PR) without requirement for additional systemic therapies for earlier progression, mixed response or nonresponse. Scoring of response will be relative to the organ stage at the time of randomization., S1 Sub-Study: EFS is defined as the time from HSCT to first failure event defined as follows: Failure events are: - Relapse - Graft failure - Death from any cause - Diagnosis of a second malignant neoplasm Patients withou

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Countries

Austria, Czechia, Denmark, Finland, France, Germany, Italy, Norway, Poland

Outcome results

None listed