| Biomarker | Variant | ESCAT | Evidence | Clinical significance | Drugs | Sources |
|---|---|---|---|---|---|---|
| No clinically actionable variants matched in this profile. | ||||||
| Biomarker | Status |
|---|---|
| BIO-HRR-PANEL | BIO definition in KB; no ESCAT BMA entry — verify with clinician |
| ID | Name | Priority | Category | Where to order | Needed for |
|---|---|---|---|---|---|
| TEST-CBC | Complete Blood Count with Differential | Critical | lab | — | all tracks |
| TEST-CECT-CAP | CECT chest/abdomen/pelvis | Critical | imaging | — | all tracks |
| TEST-CMP | Comprehensive Metabolic Panel | Critical | lab | — | all tracks |
| TEST-FISH-PANEL | FISH (Fluorescence In Situ Hybridization) | Critical | genomic | CSD Lab ✓ (code TBC) | all tracks |
| TEST-HBV-SEROLOGY | Hepatitis B Serology Panel (HBsAg, anti-HBc total, anti-HBs) | Critical | lab | — | all tracks |
| TEST-HCV-ANTIBODY | HCV Antibody | Critical | lab | — | all tracks |
| TEST-HIV-SEROLOGY | HIV Antibody/Antigen | Critical | lab | — | all tracks |
| TEST-LDH | Lactate Dehydrogenase | Critical | lab | — | all tracks |
| TEST-LFT | Liver Function Tests (ALT, AST, bilirubin, ALP, GGT, albumin) | Critical | lab | — | all tracks |
| TEST-B2-MICROGLOBULIN | Beta-2 Microglobulin | Standard | lab | — | all tracks |
| TEST-ECHO | Echocardiography | Standard | imaging | — | all tracks |
| TEST-IMMUNOGLOBULINS | Quantitative Immunoglobulins | Standard | lab | — | all tracks |
| TEST-URIC-ACID | Serum Uric Acid | Standard | lab | — | aggressive |
| TEST-NGS-LYMPHOID-PANEL | Lymphoid NGS Panel | Desired | genomic | CSD Lab ✓ (code TBC) | all tracks |
| Phase | Window | Tests | Checkpoints |
|---|---|---|---|
| Baseline | Within 2 weeks before start | TEST-CBC, TEST-CMP, TEST-LFT, TEST-LDH, TEST-B2-MICROGLOBULIN, TEST-FISH-PANEL, TEST-NGS-LYMPHOID-PANEL, TEST-IMMUNOGLOBULINS, TEST-HBV-SEROLOGY, TEST-HCV-ANTIBODY, TEST-HIV-SEROLOGY, TEST-CECT-CAP, TEST-ECHO |
|
| On treatment (BTKi) | Monthly × 3 months, then every 3 months | TEST-CBC, TEST-CMP, TEST-LFT |
|
| On treatment (venetoclax) | Per CLL14 schedule during 12-month VenO course | TEST-CBC, TEST-CMP, TEST-LFT, TEST-URIC-ACID |
|
| Response assessment | After cycle 6 (VenO) or every 6 months on BTKi | TEST-CBC, TEST-CECT-CAP, TEST-FLOW-CYTOMETRY |
|
| Follow-up | Every 3-6 months after treatment / continuously on BTKi | TEST-CBC, TEST-CMP, TEST-LFT |
|
| # | Owner | Topic | Action |
|---|---|---|---|
| 1 | molecular_geneticist | Biomarker status BLOCKING | What is the status of NOTCH1 mutation (PEST domain) (BIO-NOTCH1-MUTATION)? It is required by track(s): IND-CLL-1L-BTKI, IND-CLL-1L-VENO, IND-CLL-1L-ZANUBRUTINIB. Expected value: NOTCH1-mutated CLL has poorer prognosis but does not exclude BTKi; useful prognostic stratifier. |
| 2 | pathologist | Biomarker status BLOCKING | What is the status of CD23 expression by IHC / flow cytometry (BIO-CD23-IHC)? It is required by track(s): IND-CLL-1L-BTKI, IND-CLL-1L-VENO, IND-CLL-1L-ZANUBRUTINIB. Expected value: positive (CD23+) — part of CLL diagnostic immunophenotype panel (Matutes score); distinguishes from MCL. |
| 3 | pathologist | Biomarker status BLOCKING | What is the status of CD5 expression by IHC / flow cytometry (BIO-CD5-IHC)? It is required by track(s): IND-CLL-1L-BTKI, IND-CLL-1L-VENO, IND-CLL-1L-ZANUBRUTINIB. Expected value: positive (CD5+) — part of CLL diagnostic immunophenotype panel (Matutes score). |
| 4 | hematologist | Staging / disease burden | What is the current LDH? Marker of tumor burden and transformation. |
| 5 | clinical_pharmacist | Specialist review | Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication. |
| Missing biomarker | Label | MDT owner | Default track | Required by | Next action |
|---|---|---|---|---|---|
BIO-CD23-IHC | CD23 expression by IHC / flow cytometry | pathologist | yes | IND-CLL-1L-BTKI, IND-CLL-1L-VENO, IND-CLL-1L-ZANUBRUTINIB | Verify result, method, specimen, and report date before sign-off. Expected/constraint: positive (CD23+) — part of CLL diagnostic immunophenotype panel (Matutes score); distinguishes from MCL |
BIO-CD5-IHC | CD5 expression by IHC / flow cytometry | pathologist | yes | IND-CLL-1L-BTKI, IND-CLL-1L-VENO, IND-CLL-1L-ZANUBRUTINIB | Verify result, method, specimen, and report date before sign-off. Expected/constraint: positive (CD5+) — part of CLL diagnostic immunophenotype panel (Matutes score) |
BIO-NOTCH1-MUTATION | NOTCH1 mutation (PEST domain) | molecular_geneticist | yes | IND-CLL-1L-BTKI, IND-CLL-1L-VENO, IND-CLL-1L-ZANUBRUTINIB | Verify result, method, specimen, and report date before sign-off. Expected/constraint: NOTCH1-mutated CLL has poorer prognosis but does not exclude BTKi; useful prognostic stratifier |
| Specialist | skill_id | Version | Last reviewed | Sign-offs | Domain |
|---|---|---|---|---|---|
| Cellular therapy specialist (CAR-T) | cellular_therapy_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
| Clinical pharmacist | clinical_pharmacist | v0.1.0 | 2026-04-25 | 0 | clinical_pharmacy |
| Hematologist / oncohematologist | hematologist | v0.1.0 | 2026-04-25 | 0 | hematology_oncology |
| Hematopathologist (lymphoma / leukemia / myeloma) | hematopathologist | v0.1.0 | 2026-04-25 | 0 | hematopathology |
| Infectious disease / hepatology | infectious_disease_hepatology | v0.1.0 | 2026-04-25 | 0 | infectious_diseases |
| Medical oncologist (solid-tumor chemotherapist) | medical_oncologist | v0.1.0 | 2026-04-25 | 0 | solid_oncology |
| Molecular geneticist / molecular oncologist | molecular_geneticist | v0.1.0 | 2026-04-25 | 0 | molecular_oncology |
| Palliative care | palliative_care | v0.1.0 | 2026-04-25 | 0 | palliative_care |
| Pathologist (general) | pathologist | v0.1.0 | 2026-04-25 | 0 | pathology |
| Primary care / family physician | primary_care | v0.1.0 | 2026-04-25 | 0 | primary_care |
| Psycho-oncologist | psychologist | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Radiation oncologist | radiation_oncologist | v0.1.0 | 2026-04-25 | 0 | radiation_oncology |
| Radiologist | radiologist | v0.1.0 | 2026-04-25 | 0 | diagnostic_imaging |
| Social worker / case manager | social_worker_case_manager | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Surgical oncologist | surgical_oncologist | v0.1.0 | 2026-04-25 | 0 | surgical_oncology |
| Transplant specialist (BMT) | transplant_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
| NCT | Title | Phase | Status | Sponsor | UA | Signals | Eligibility (excerpt) |
|---|---|---|---|---|---|---|---|
| NCT04771572 | Study of Oral Administration of LP-118 in Patients With Relapsed or Refractory CLL, SLL, MDS, MDS/MPN, AML, CMML-2, MPN-BP, ALL, MF, NHL, RT, MM or T-PLL. | PHASE1 | RECRUITING | Newave Pharmaceutical Inc | — | Phase 1 only Single country | |
| NCT06588478 | A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | PHASE2 | RECRUITING | Loxo Oncology, Inc. | — | Surrogate endpoint only | |
| NCT06564038 | A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies | PHASE1 / PHASE2 | RECRUITING | AstraZeneca | — | — | |
| NCT06378138 | ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03) | PHASE2 / PHASE3 | RECRUITING | Beijing InnoCare Pharma Tech Co., Ltd. | — | Single country | |
| NCT04215809 | Study of APG-2575 as a Single Agent or in Combination With Other Therapeutic Agents for CLL/SLL | PHASE1 | RECRUITING | Ascentage Pharma Group Inc. | — | Phase 1 only | |
| NCT00923507 | Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL) | N/A | RECRUITING | National Heart, Lung, and Blood Institute (NHLBI) | — | Single country | |
| NCT03666000 | Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL) | PHASE1 | RECRUITING | Imugene Limited | — | Phase 1 only Surrogate endpoint only | |
| NCT04892277 | CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies | PHASE1 | RECRUITING | Mayo Clinic | — | Phase 1 only Small N (<50) Single country | |
| NCT06539182 | DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8) | PHASE2 | RECRUITING | Dizal Pharmaceuticals | — | Surrogate endpoint only Single country | |
| NCT05254743 | A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) | PHASE3 | RECRUITING | Loxo Oncology, Inc. | — | Surrogate endpoint only |
Verify recruitment status directly with the trial site. ctgov data can lag behind current UA-site status.
| Option | UA registration | NSZU | Cost orientation | Access pathway |
|---|---|---|---|---|
| Standard plan Acalabrutinib monotherapy (continuous, until progression or intolerance) (REG-ACALABRUTINIB-CONTINUOUS) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Aggressive plan Venetoclax + Obinutuzumab (VenO), 12 months fixed-duration (CLL14 schedule) (REG-VENETOCLAX-OBINUTUZUMAB) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Standard plan Zanubrutinib monotherapy (continuous, ALPINE-style) (REG-ZANUBRUTINIB-CONTINUOUS) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Aggressive plan Acalabrutinib + Venetoclax + Obinutuzumab (AVO), fixed-duration 14 cycles (AMPLIFY) (REG-AVO-CLL-1L) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Trial · NCT04771572 Study of Oral Administration of LP-118 in Patients With Relapsed or Refractory CLL, SLL, MDS, MDS/MPN, AML, CMML-2, MPN-BP, ALL, MF, NHL, RT, MM or T-PLL. No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06588478 A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06564038 A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06378138 ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03) No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT04215809 Study of APG-2575 as a Single Agent or in Combination With Other Therapeutic Agents for CLL/SLL No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT00923507 Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL) No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT03666000 Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL) No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT04892277 CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06539182 DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8) No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05254743 A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
Cost information is orientation. Verify with a specific pharmacy / foundation / trial site. Status updated: 2026-08-17.