ItaliaN Observational Study of Patients With Acute Lymphoblastic Leukemia Treated With Anti-CD22 Immunoconjugate

NCT ID: NCT03898128

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 84 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-27
• Study Completion Date: 2021-09-30

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.

Conditions

Acute Lymphoblastic Leukemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Anti-CD22 Immunotoxin

Clinical data (treatment, survival, adverse events) of patients treated with anti-CD22 immunoconjugates from 2014 will be collected

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giovanni Martinelli, Prof

Role: STUDY_DIRECTOR

IRST IRCCS

Delia Cangini, MD

Role: PRINCIPAL_INVESTIGATOR

IRST IRCCS

Locations

Irst Irccs

Meldola (FC), FC, Italy

AUSL Romagna

Ravenna, RA, Italy

Azienda ULSS2 Marca Trevigiana

Treviso, TV, Italy

ULSS 3 Serenissima

Mestre, Venezia, Italy

Ospedale S. Eugenio

Roma, , Italy

Countries

Italy

Other Identifiers

IRST204.03

Identifier Type: -

Identifier Source: org_study_id