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

NCT03898128 | Completed

• 1 other identifier: IRST204.03
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 5

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

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall survival

  up to 18 months

• Disease free survival

  up to 18 months

• Response to therapy

  up to 18 months

Interventions

Anti-CD22 Immunotoxin DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (5)

Irst Irccs

Meldola (FC), FC, 47014, Italy

Location

AUSL Romagna

Ravenna, RA, 48121, Italy

Location

Azienda ULSS2 Marca Trevigiana

Treviso, TV, 31100, Italy

Location

ULSS 3 Serenissima

Mestre, Venezia, 30174, Italy

Location

Ospedale S. Eugenio

Roma, 00144, Italy

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Giovanni Martinelli, Prof

  IRST IRCCS

  STUDY DIRECTOR

• Delia Cangini, MD

  IRST IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 1, 2019
• Study Start: November 27, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: December 3, 2025

Record last verified: 2025-12

Locations

IT (5)