Quality Assurance of Secondary Immunodeficiencies (SID) in CLL/MM Patients

Secondary Immunodeficiencies (SID) Clinical Trial

— QS-SID  

Official title:

Quality Assurance on Diagnosis and Therapy of Secondary Immunodeficiencies (SID) in Patients With Chronic Lymphocytic Leukemia (CLL) or Multiple Myeloma (MM) in Germany (QS-SID)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04172467
• Other study ID #: AIO-SUP-0119ass (QS SID)
• Status: Completed
• Start date: January 28, 2020
• Est. completion date: August 3, 2020

Study information

• Verified date: November 2021
• Source: AIO-Studien-gGmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Retrospective, representative registry for quality assurance on diagnosis and therapy of secondary immunodeficiencies (SID) in patients with chronic lymphocytic leukemia (CLL) or multiple myeloma (MM)

Description:

Treatment structure analysis and recruitment (phase 1):

In a first step, data on care facilities, that treat patients with CLL or MM in Germany is obtained.

In phase 1 all centers in Germany that potentially treat patients with the CLL or MM are contacted and data of its facility care level and its number of treated patients is recorded using a one-sided pen-to-paper form. In addition, the willingness of care facilities to become involved in patients' documentation is elicited (phase 2).

Patient documentation (phase 2)

To achieve a reliable, representative sample of patients treated in Germany, the distribution of cases to be documented is specified in the individual indications amongst the facilities involved. This is done using the facilities' data on patient numbers and treatment structure obtained in phase I:

The participating centers are assigned to clusters based on key distinguishing features (facility type, care level and number of patients treated). This sample is modulated according to the previous treatment structure analysis. By taking this approach, the actual percentages of the various care facilities in an indication area can be reflected proportionally in the patient documentation sample.

In phase 2 a electronic case record form (eCRF) is completed in order to collect the original patient and treatment data, which are relevant to the purpose of the study. All data is gathered retrospectively and anonymously using the patient files. Patient and disease related variables (age, general condition according to the Eastern Cooperative Oncology Group (ECOG), relevant comorbidity, staging and relevant mutations), systemic antineoplastic treatment (chemotherapy, antibodies, kinase-inhibitors, relevant co-medication etc.) are recorded. Also, data on diagnosis of Ig-levels (IgG, IgA, IgM), therapy of secondary immunodeficiencies as well as the number and severity of occurred infections and their treatment is collected. Clusters for classification of infections will be developed (e.g. life-threatening, need for hospitalization).

In order to ensure data quality, the scientific project lead will provide training for two employees of the commissioned institute on matters regarding the content of the study. This knowledge will be incorporated into the programming of the user interface and the patient databases so that the program will check for completeness and, as far as possible, plausibility, on the basis of defined requirements and constraints. These checks accompany the process of entering data into the eCRF and allow for validating data instantly. If inconsistencies, mistakes or omissions are detected, data will be validated by an integrated query management system.

Physicians questionnaire (phase 3)

In an additional step and alongside the patient documentation, the attending physicians in participating centers will be surveyed (phase 3) on their competency profile, their assessment of guideline quality and their approach to avoid infections of CLL and MM patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1086
• Est. completion date: August 3, 2020
• Est. primary completion date: April 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with CLL or MM

• anti-neoplastic systemic therapy (all therapy lines) between July 1st 2017 and June 30th 2018

Exclusion Criteria:

• patient in terminal phase of the disease, life expectancy less than three months

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Neoplasm Metastasis
• Secondary Immunodeficiencies (SID)

Intervention

Other:
• non-interventional retrospective epidemiological observational study
non-interventional retrospective epidemiological observational study

Locations

Country	Name	City	State
Germany	Privatärztliche Praxis; Innere Medizin, Hämatologie, Internistische Onkologie	Kaiserslautern

Sponsors (6)

Lead Sponsor	Collaborator
AIO-Studien-gGmbH	AGSMO (Arbeitsgemeinschaft Supportive Maßnahmen in der Onkologie), AIO AG Supportivtherapie, MMF GmbH, Prof. Hartmut Link, Takeda

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Guideline Adherence (GLAD)	For SID, immunoglobulin substitution (IgRT) is mandatory only for patients with an IgG level < 4g/l (or IgG subclass deficiency) and additionally more than 3 infections or a severe infection (= grade 3) and is optional (may be appropriate) if IgG level < 4g/l and/or 1-3 less severe infections (= grade 2). IgRT is not indicated if patients do not fulfil either condition.; Scoring system: GLAD-Score 2: full guideline adherence GLAD-Score 1: deviations in dose or interval (+/- 10%) or a late start of IgRT (>28 days after a severe infection (= grade 3).; GLAD-Score 0: IgRT without indication (overuse) or omitted IgRT despite recommendation (underuse). Likewise, 0 points were awarded if both the dose and the interval deviated from the GL recommendations (e.g. underdosed single dose) or if IgRT was not started until more than 3 months after hypogammaglobulinemia and at least one severe infection.	Median study observation period of 18.2 months
Secondary	Guideline Adherence and Susceptibility to Infection	For the analysis of susceptibility to infection, the time to next infection was examined using the Andersen-Gill model for recurrent events. For effect estimation, hazard ratios are reported with 95% confidence interval in each case. GLAD-Score 2 is Reference, a higher hazard ratio means a higher susceptibility to infection.	Median study observation period of 18.2 months