A Study of Secondary Immunodeficiencies in Adults With Blood Cancers in Kazakhstan Who Have a Weakened Immune System (K-SIDE Study)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTakeda

About this trial

Some people with blood cancers (hematologic malignancies) develop a weakened immune system because of their condition or the medicines used to treat it. This is called a secondary immunodeficiency or SID. A weakened immune system can make it harder for the body to fight infections. SIDs make participants more likely to have serious infections, need treatment at a hospital, and need longer treatment periods with antibiotics. SIDs are common but often overlooked in people with blood cancers in Kazakhstan. Currently, Kazakhstan does not have national guidelines for diagnosing and managing SIDs, which leads to differences in how people are assessed and treated across healthcare settings.

The main aim of this study is to understand how common SIDs are in adults with blood cancers in Kazakhstan, which people are most affected and how often related health problems such as infections happen. Other aims are to learn more about SIDs in Kazakhstan: how SIDs are treated, how they affect a person's health and daily life (clinical burden) and how certain factors (such as age, health condition, treatment, type and stage of the blood cancer) may influence SIDs.

This study will not collect any new data. It will use existing health records and data from Kazakhstan's national oncology registry.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults greater than or equal to (>=)18 years of age.

Multiple Myeloma

Chronic Lymphocytic Leukemia

Non-Hodgkin Lymphoma

Disqualifiers

Age <18 years.

Primary immunodeficiency (PID) diagnosis.

No available EHR data within the study observation period.

Previous enrolment in a therapeutic investigational drug or device trial during the study observation period.

Trial population

The study population will include participants who have been diagnosed with HM and documented SID and/or evidence meeting the study SID definition. The participants must be treated at the National Oncology Center (Astana) with available EHR data in the Kazakhstan National Oncology Registry/EHR.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • No Intervention

    Other intervention

    This is a non-interventional study.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: HM participants with SID1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants With Hematologic Malignancies Who Meet the Protocol-defined SID Criteria

The percentage of participants with hematologic malignancies who meet the protocol-defined SID criteria will be reported. SID is defined as IgG \<5 g/L, proven specific antibody failure, and/or a history of severe or recurrent infections. Each participant will be assessed from the start of available EHR data until the earliest of the last available EHR, follow-up, death, or the retrospective data cut-off date. Cut-off date, is defined as the final date of data availability included in the study dataset, corresponding to the initiation of data extraction from the EHR/registry: all eligible participant data recorded in the EHR/registry up to and including this date will be considered for analysis.

Time frame
Up to 6 years

Secondary outcomes

1

Number of Infection Episodes During the Post-index Observation Period

Time frame
Up to 6 years
2

Frequency of Infection Episodes During the Post-index Observation Period

Time frame
Up to 6 years
3

Number of Participants Receiving Antibiotic or Antimicrobial Therapy

Time frame
Up to 6 years
4

Overall Hospitalization Rate

Time frame
Up to 6 years

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: