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

Acute Lymphoblastic Leukemia Clinical Trial

— INO-CD22  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03898128
• Other study ID #: IRST204.03
• Status: Recruiting
• Start date: November 27, 2019
• Est. completion date: September 2021

Study information

• Verified date: February 2021
• Source: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Contact: Oriana Nanni, Dr
• Phone: +39 0543 739266
• Email: oriana.nanni[@]irst.emr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
Italy	Irst Irccs	Meldola (FC)	FC
Italy	ULSS 3 Serenissima	Mestre	Venezia
Italy	AUSL Romagna	Ravenna	RA
Italy	Ospedale S. Eugenio	Roma
Italy	Azienda ULSS2 Marca Trevigiana	Treviso	TV

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events of grade 3 and 4	toxicity profile of the therapy with antiCD22 immunoconjugates in patients with ALL	up to 12 months
Secondary	Overall survival	Overall Survival (OS), defined as the number of days between the first study drug administration and death from any cause	up to 18 months
Secondary	Disease free survival	Disease Free Survival (DFS), defined as the number of days between the first study drug administration and any event including disease progression or death from any cause	up to 18 months
Secondary	Response to therapy	response to therapy (CR, CRi, MRD and bridge to transplant)	up to 18 months