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Pharmacology of BCL2 Inhibitors in hematological diseases (PhaB2i)

Pharmacology of BCL2 Inhibitors in hematological diseases (PhaB2i) - PhaB2i

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00038058
Enrollment
176
Registered
2025-10-31
Start date
2025-10-30
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C81-C96

Interventions

Group 1: myeloid diseases: every 3 months, BCL2 inhibitor plasma concentration is measured, dietary habits are recorded, side effects, concomitant medication, frailty, quality of life, disease progres

Sponsors

Universitätsmedizin Rostock, Department für Innere Medizin, Klinik und Poliklinik für Hämatologie, Hämostaseologie, Onkologie, Stammzelltherapie und Palliativmedizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Outpatient/inpatient treatment in the context of hematological disease Intake of BCL2 inhibitors

Exclusion criteria

Exclusion criteria: not capable of giving consent Failure to meet an inclusion criterion

Design outcomes

Primary

MeasureTime frame
Feasibility of measuring the BCL2 inhibitor concentration (i.e., Venetoclax) in blood plasma in hematological disorders?

Secondary

MeasureTime frame
1. Is there a correlation between dietary habits and BCL2i plasma concentration? 2. Is there a correlation between concomitant medication and BCL2i plasma concentration? 3. Is there a correlation between side effects (CTCAE) and BCL2i plasma concentration? 4. Is there a correlation between the degree of frailty and BCL2i plasma concentration? a. Is there a correlation with G8 (initial/progression)? b. Is there a correlation with SPPB (initial/progression)? c. Is there a correlation with dynamometer measurement (initial/progression)? 5. Is there a correlation between quality of life (EORTC QLQ C30) and BCL2i plasma concentration? 6. Is there a correlation between pre-existing conditions (HCT-CI) and BCL2i plasma concentration? 7. Is there a correlation between disease type (AML/CLL) and BCL2i plasma concentration (initial/progression)? 8. Self-assessment of patients regarding intensive therapy vs. medical professional assessment regarding intensive therapy (e.g., transplantation)? 9. Is there a change in body composition (BIA measurement) with disease progression? 10. Does the change in body composition (BIA measurement) have an effect on the BCL2i plasma concentration? 11. Is there a correlation between changes in dietary habits and BCL2i plasma concentration? 12. Is there a correlation between changes in concomitant medication and BCL2i plasma concentration? 13. Is there a correlation between changes in disease progression and BCL2i plasma concentration?

Countries

Germany

Contacts

Public ContactChristian Schmidt

Universitätsmedizin Rostock, Department für Innere Medizin, Klinik und Poliklinik für Hämatologie, Hämostaseologie, Onkologie, Stammzelltherapie und Palliativmedizin

haema-studie-phab2i@med.uni-rostock.de+49 381 494144223

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026