An observational study in Secondary Immunodeficiency (SID), sponsored by Takeda. Not yet recruiting at 1 site in Kazakhstan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Takeda · Observational
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.
Takeda is the lead sponsor of 1,025 studies on the registry; 91 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 153 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria: Participants must meet all of the following criteria:
Confirmed diagnosis of a hematologic malignancy (preceding SID diagnosis and/or evidence, as defined in inclusion criterion 4), including but not limited to:
For the SID cohort: confirmed diagnosis of SID OR evidence of secondary immunodeficiency, defined by one or more of the following:
History of severe or recurrent infections, defined as:
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
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
This is a non-interventional study.
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
Number of Infection Episodes During the Post-index Observation Period
Time frame: Up to 6 years
Frequency of Infection Episodes During the Post-index Observation Period
Time frame: Up to 6 years
Number of Participants Receiving Antibiotic or Antimicrobial Therapy
Time frame: Up to 6 years
Overall Hospitalization Rate
Time frame: Up to 6 years
Infection-related Hospitalization Rate
Time frame: Up to 6 years
Number of Participants who had Intensive Care Unit (ICU) Admissions
Time frame: Up to 6 years
Number of Participants With Emergency Department Visits
Time frame: Up to 6 years
Length of Hospital Stay
Time frame: Up to 6 years
Percentage of Participants With Hospital Readmission Within 30 Days
Time frame: Up to 6 years
Duration of Receiving Intravenous (IV) or Subcutaneous (SC) Immunoglobulin Replacement Therapy (IgRT)
Time frame: Up to 6 years
Number of Participants Receiving Prophylactic Antibiotics or Antivirals
Time frame: Up to 6 years
Number of Diagnostic Tests and Monitoring Assessments for SID
Time frame: Up to 6 years
Number of Participants Categorized by SID Severity
Time frame: Up to 6 years
Number of Participants With Comorbidities
Time frame: Up to 6 years
Number of Participants Categorized by Hematologic Malignancy Subtype
Time frame: Up to 6 years
Number of Participants Categorized by Disease Characteristics
Time frame: Up to 6 years
Number of Participants Categorized by Oncology Therapy Exposure
Time frame: Up to 6 years
Number of Participants Categorized by Type of Oncology Therapy
Time frame: Up to 6 years
Number of Participants Categorized by IgRT Subgroup
Time frame: Up to 6 years
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.