Interfant-21: International collaborative treatment protocol for infants under one year with KMT2A-rearranged acute lymphoblastic leukemia or mixed phenotype acute leukemia

Conditions

Acute lymphoblastic leukemia

Brief summary

EFS defined as the time from diagnosis to resistance to induction (i.e. no complete remission at the end of induction) , relapse, death from any cause or second malignancy (whichever occurs first), or time to last follow-up (censored) for patients without events.

Detailed description

OS is defined as the time from the date of diagnosis to death from any cause. Patients who are alive will be censored at the date of last follow up. OS will be estimated for the entire study cohort and according to risk group., The endpoints for analysis by risk group will be EFS, cumulative incidence (or percentage) of resistance to induction (no complete remission at the end of induction) , cumulative incidence of relapse (CIR), death in complete remission (CR) and second malignancy., Outcome for the entire study cohort and according to risk group will be evaluated in terms of the protocol specific definition of EFS follows: the time from diagnosis to, resistance to proto-col, relapse, death from any cause or second malignancy (whichever occurs first), or time to last follow-up for patients without events. Cumulative incidence (or percentage) of resistance, CIR, death in CR and second malignancy will also be estimated., MRD response as defined in the protocol and frequencies of MRD levels., Proportion of CD19 negative relapses in the entire study cohort and according to risk group., Proportion of myeloid lineage switches in the entire study cohort and according to risk group., Proportion of grade ≥3 adverse event (AEs) during the blinatumomab course(s). Proportion of adverse events of special interest (AESIs) and serious adverse events (SAEs) in all protocol phases., Proportion of grade ≥2 cardiac disorders (See AESI Table in protocol) at 2 and 5 years after diagnosis, OS after first relapse, defined as the time from first relapse to death from any cause, in the entire study cohort and according to risk group.

Related papers

No related papers found yet.

Interventions

DRUGSpectrila 10

DRUG000 U powder for concentrate for solution for infusion

DRUGXaluprine 20 mg/ml oral suspension

DRUGToposin

DRUGconcentraat voor oplossing voor intraveneuze infusie 20 mg/ml

DRUGDexamethason Teva 1

DRUG5 mg

DRUGtabletten

DRUGDexamethasone phosphate 4 mg/ml solution for injection

DRUGVincristinesulfaat Teva 1 mg/ml

DRUGoplossing voor injectie

DRUGDexamethasone 10mg/5ml Oral Solution

DRUGThiosix 10 mg

DRUGEmthexate PF 100 mg/ml

DRUGSolu-Cortef Powder for Solution for Injection or Infusion 100 mg

DRUGENDOXAN I.V.

DRUGpoeder voor oplossing voor injectie (lyofilisaat) 1000 mg

DRUGMethotrexaat Teva 10 mg

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

DRUGpoeder voor oplossing voor injectie (lyofilisaat) 500 mg

DRUGPrednison Auro 5 mg

DRUGDexamethason Teva 0

DRUGThiosix 20 mg

DRUGMethotrexaat Teva 2

DRUGMitoxantron Sandoz 2 mg/ml

DRUGconcentraat voor oplossing voor infusie

DRUGCerubidine 20 mg

DRUGpoeder en oplosmiddel voor oplossing voor injectie

DRUGCytarabine Accord 100 mg/ml

DRUGoplossing voor injectie of infusie

DRUGSolu-Medrone powder and solvent for solution for injection or concentrate for solution for infusion 1000 mg/vial.

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
EFS defined as the time from diagnosis to resistance to induction (i.e. no complete remission at the end of induction) , relapse, death from any cause or second malignancy (whichever occurs first), or time to last follow-up (censored) for patients without events.	—

Secondary

Measure	Time frame
OS is defined as the time from the date of diagnosis to death from any cause. Patients who are alive will be censored at the date of last follow up. OS will be estimated for the entire study cohort and according to risk group., The endpoints for analysis by risk group will be EFS, cumulative incidence (or percentage) of resistance to induction (no complete remission at the end of induction) , cumulative incidence of relapse (CIR), death in complete remission (CR) and second malignancy., Outcome for the entire study cohort and according to risk group will be evaluated in terms of the protocol specific definition of EFS follows: the time from diagnosis to, resistance to proto-col, relapse, death from any cause or second malignancy (whichever occurs first), or time to last follow-up for patients without events. Cumulative incidence (or percentage) of resistance, CIR, death in CR and second malignancy will also be estimated., MRD response as defined in the protocol and frequencies of MRD l	—

Measure

Time frame

OS is defined as the time from the date of diagnosis to death from any cause. Patients who are alive will be censored at the date of last follow up. OS will be estimated for the entire study cohort and according to risk group., The endpoints for analysis by risk group will be EFS, cumulative incidence (or percentage) of resistance to induction (no complete remission at the end of induction) , cumulative incidence of relapse (CIR), death in complete remission (CR) and second malignancy., Outcome for the entire study cohort and according to risk group will be evaluated in terms of the protocol specific definition of EFS follows: the time from diagnosis to, resistance to proto-col, relapse, death from any cause or second malignancy (whichever occurs first), or time to last follow-up for patients without events. Cumulative incidence (or percentage) of resistance, CIR, death in CR and second malignancy will also be estimated., MRD response as defined in the protocol and frequencies of MRD l

—

Countries

Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden

Outcome results

None listed