Clinical trial NCT03898128: ItaliaN Observational Study of Patients With Acute Lymphoblastic Leukemia Treated With Anti-CD22 Immunoconjugate
Official title: ItaliaN Observational Study of Patients With Acute Lymphoblastic Leukemia Treated With Anti-CD22 Immunoconjugate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALL patients treated with anti-CD22 immunoconjugate drugs from 1-Jan-2014 to 01-Mar-2019

Brief summary: In phase 2 and phase 3 studies, inotuzumab has shown evidence of single agent anti-leukemic activity and proved to be particularly effective in providing a deep response, with an acceptable safety profile. Since 2014 anti-CD22 has been available for compassionate use in Italy.

In this non-interventional retrospective study, toxicity, effectiveness and costs assessment data will be collected from patients with ALL, to improve the knowledge about anti-CD22 treatment in clinical practice. Collecting data of patients and analyzing a large unbiased patient-set of patients receiving anti-CD22 immunoconjugates could enlarge our knowledge on therapies engaging CD22

Detailed description: In phase 2 and phase 3 studies, inotuzumab has shown evidence of single agent anti-leukemic activity and proved to be particularly effective in providing a deep response, with an acceptable safety profile. Since 2014 anti-CD22 has been available for compassionate use in Italy.

In this non-interventional retrospective study, toxicity, effectiveness and costs assessment data will be collected from patients with ALL, to improve the knowledge about anti-CD22 treatment in clinical practice.

Despite recent advancements in the treatment of hematological malignancies, still a considerable number of cases cannot be cured and represent real societal challenges with a relevant social and economic impact. Indeed, treatments are becoming more expensive and the current state of the art does not allow a good prediction of the therapeutic outcome. In particular, several steps of the diagnostic and therapeutic paths should be improved, from early and advanced diagnosis, in order to avoid treatment delays or impairment, to prognostic assessment and monitoring of therapeutic response. The unsatisfactory response to conventional chemotherapy has led to the development of high-cost targeted therapies, whose administration and schedules has to be guided by defined molecular criteria. Beside the economic perspective, these novel drugs have relevant side effects that cannot be predicted before treatment starts.

The management of hematological malignancies is further complicated by the high level of disease heterogeneity in terms of pathogenetic and molecular mechanisms. A number of subtypes have been defined for each disease, based on cytogenetic and molecular profiles and relevant differences can be even observed within the same disease subtype, leading to different clinical outcomes and responses to treatment and to guide therapeutic decisions for patients affected by CD22 positive ALL.

Due to the observational nature of the study, for the patient there is no benefit expected. For this observational nature of the study, for the patient there is no risk about his health. Data will be treated according GCP/EU laws/Italian laws/local laws according the most restrictive between these laws.

Eligibility criteria: Inclusion Criteria:

1. Patient with ALL according WHO 2016 classification.
2. Patient who received any anti-CD22 immunoconjugate from 2014 to 01-Mar-2019 outside clinical trials.

Exclusion Criteria:

1. Patients who received anti-CD22 treatment within a clinical trial

Primary outcomes:
measure: Incidence of Adverse Events of grade 3 and 4
timeFrame: up to 12 months
Secondary outcomes:
measure: Overall survival
timeFrame: up to 18 months
measure: Disease free survival
timeFrame: up to 18 months
measure: Response to therapy
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Meldola (FC)
country: Italy
facility: Irst Irccs
state: FC
city: Ravenna
country: Italy
facility: AUSL Romagna
state: RA
city: Treviso
country: Italy
facility: Azienda ULSS2 Marca Trevigiana
state: TV
city: Mestre
country: Italy
facility: ULSS 3 Serenissima
state: Venezia
city: Roma
country: Italy
facility: Ospedale S. Eugenio
Study officials:
affiliation: IRST IRCCS
name: Giovanni Martinelli, Prof
role: STUDY_DIRECTOR
affiliation: IRST IRCCS
name: Delia Cangini, MD
role: PRINCIPAL_INVESTIGATOR
References: