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

NCT07868107 | Not Yet Recruiting

• 1 other identifier: TAK-771-4015
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Secondary Immunodeficiency (SID)

Keywords

Drug Therapy

Outcome Measures

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.

  Up to 6 years

Secondary Outcomes (19)

• Number of Infection Episodes During the Post-index Observation Period

  Up to 6 years

• Frequency of Infection Episodes During the Post-index Observation Period

  Up to 6 years

• Number of Participants Receiving Antibiotic or Antimicrobial Therapy

  Up to 6 years

• Overall Hospitalization Rate

  Up to 6 years

• Infection-related Hospitalization Rate

  Up to 6 years

Study Arms (1)

HM participants with SID

Adult participants with a hematologic malignancy treated at the National Oncology Center (Astana) and recorded in the Kazakhstan National Oncology Registry/electronic health record (EHR) will be included. Eligible participants must have a documented diagnosis of SID and/or evidence meeting the protocol-defined SID criteria, defined by immunoglobulin (IgG) less than (\<) 5 grams per liter (g/L), specific antibody failure, or severe/recurrent infections. Data from January 2021 until study start (estimated April 2027) will be evaluated.

Other: No Intervention

Interventions

No Intervention OTHER

This is a non-interventional study.

HM participants with SID

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

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.

You may qualify if:

• Adults greater than or equal to (\>=)18 years of age.
• Multiple Myeloma
• Chronic Lymphocytic Leukemia
• Non-Hodgkin Lymphoma
• Acute Leukemia
• Myeloproliferative Neoplasm
• Available EHR data within the study observation period.
• For the SID cohort: confirmed diagnosis of SID OR evidence of secondary immunodeficiency, defined by one or more of the following:
• Serum IgG \<5 g/L, and/or
• Proven Specific Antibody Failure (PSAF), and/or
• History of severe or recurrent infections, defined as:
• \>=3 infections per annum requiring treatment with antibiotics (ideally microbiologically proven), and/or
• Radiologically proven pneumonia, and/or
• Culture-proven sepsis or febrile neutropenia, and/or
• Other infection requiring hospitalization and IV antibiotics

You may not qualify if:

• Participants meeting any of the following criteria will be excluded:
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

National Research Oncology Center

Astana, Z05T6H4, Kazakhstan

Location

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Director

CONTACT

Study Design

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

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

KA (1)