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

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ClinicalTrials.gov Identifier: NCT03898128
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

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


Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia 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.


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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: ItaliaN Observational Study of Patients With Acute Lymphoblastic Leukemia Treated With Anti-CD22 Immunoconjugate
Estimated Study Start Date : March 29, 2019
Estimated Primary Completion Date : October 29, 2020
Estimated Study Completion Date : March 29, 2021



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


Primary Outcome Measures :
  1. Incidence of Adverse Events of grade 3 and 4 [ Time Frame: up to 12 months ]
    toxicity profile of the therapy with antiCD22 immunoconjugates in patients with ALL


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: up to 18 months ]
    Overall Survival (OS), defined as the number of days between the first study drug administration and death from any cause

  2. Disease free survival [ Time Frame: up to 18 months ]
    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

  3. Response to therapy [ Time Frame: up to 18 months ]
    response to therapy (CR, CRi, MRD and bridge to transplant)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ALL patients treated with anti-CD22 immunoconjugate drugs from 1-Jan-2014 to 01-Mar-2019
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898128


Contacts
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Contact: Oriana Nanni, Dr +39 0543 739266 oriana.nanni@irst.emr.it

Locations
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Italy
Irst Irccs Not yet recruiting
Meldola (FC), Italy, 47014
Contact: Delia Cangini, MD       delia.cangini@irst.emr.it   
AUSL Romagna Not yet recruiting
Ravenna, Italy, 48121
Contact: Francesco Lanza, MD       francesco.lanza@auslromagna.it   
Sponsors and Collaborators
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Investigators
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Study Director: Giovanni Martinelli, Prof IRST IRCCS
Principal Investigator: Delia Cangini, MD IRST IRCCS

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Responsible Party: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
ClinicalTrials.gov Identifier: NCT03898128     History of Changes
Other Study ID Numbers: IRST204.03
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunotoxins
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs