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

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

Study Overview

• Status: Unknown
• Conditions: Acute Lymphoblastic Leukemia
• Intervention / Treatment: Drug: Anti-CD22 Immunotoxin

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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Oriana Nanni, Dr; Phone Number: +39 0543 739266; Email: oriana.nanni@irst.emr.it

Study Locations

• Italy
  • Roma, Italy, 00144
    • Recruiting
    • Ospedale S. Eugenio
    • Contact: Paolo De Fabritiis, MD
  • FC
    • Meldola (FC), FC, Italy, 47014
      • Recruiting
      • Irst Irccs
      • Contact: Delia Cangini, MD
  • RA
    • Ravenna, RA, Italy, 48121
      • Recruiting
      • Ausl Romagna
  • TV
    • Treviso, TV, Italy, 31100
      • Recruiting
      • Azienda ULSS2 Marca Trevigiana
      • Contact: Michele Gottardi, MD
  • Venezia
    • Mestre, Venezia, Italy, 30174
      • Recruiting
      • ULSS 3 Serenissima
      • Contact: Renato Bassan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ALL patients treated with anti-CD22 immunoconjugate drugs from 1-Jan-2014 to 01-Mar-2019

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Response to therapy	response to therapy (CR, CRi, MRD and bridge to transplant)	up to 18 months

Collaborators and Investigators

• Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Investigators: Study Director: Giovanni Martinelli, Prof, Irst Irccs; Principal Investigator: Delia Cangini, MD, Irst Irccs

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: March 29, 2019
• First Submitted That Met QC Criteria: March 29, 2019
• First Posted (Actual): April 1, 2019

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Physiological Effects of Drugs; Immunologic Factors; Immunotoxins
• Other Study ID Numbers: IRST204.03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No