| Biomarker | Variant | ESCAT | Evidence | Clinical significance | Drugs | Sources |
|---|---|---|---|---|---|---|
| ESCAT: clinical review pendingBIO-TP53-MUTATION | any pathogenic mutation OR del(17p) | IIA | TP53-mut MCL — predicts chemoimmuno failure. Acalabrutinib + rituximab (TRIANGLE / ECHO) preferred over R-CHOP/R-DHAP+autoSCT regardless of fitness. | acalabrutinib + rituximab (1L) ibrutinib + rituximab + venetoclax (R/R) CAR-T brexu-cel (R/R) |
|
| ID | Name | Priority | Category | Where to order | Needed for |
|---|---|---|---|---|---|
| TEST-BM-ASPIRATE | Bone Marrow Aspirate | Critical | histology | — | aggressive |
| TEST-BM-TREPHINE | Bone Marrow Trephine | Critical | histology | — | aggressive |
| TEST-CBC | Complete Blood Count with Differential | Critical | lab | — | all tracks |
| TEST-CD20-IHC | CD20 Immunohistochemistry | Critical | histology | CSD Lab ✓ (code TBC) | 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 | — | aggressive |
| 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-LN-EXCISIONAL-BIOPSY | Excisional LN Biopsy | Critical | histology | — | aggressive |
| TEST-PREGNANCY | Beta-HCG | Critical | lab | — | aggressive |
| TEST-B2-MICROGLOBULIN | Beta-2 Microglobulin | Standard | lab | — | aggressive |
| TEST-ECHO | Echocardiography | Standard | imaging | — | all tracks |
| TEST-PET-CT | FDG PET/CT (whole body) | Standard | imaging | — | all tracks |
| 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 |
|
| Phase | Window | Tests | Checkpoints |
|---|---|---|---|
| Baseline | Within 2 weeks before cycle 1 | TEST-CBC, TEST-CMP, TEST-LFT, TEST-LDH, TEST-B2-MICROGLOBULIN, TEST-HBV-SEROLOGY, TEST-HCV-ANTIBODY, TEST-HIV-SEROLOGY, TEST-PET-CT, TEST-LN-EXCISIONAL-BIOPSY, TEST-FLOW-CYTOMETRY, TEST-CD20-IHC, TEST-ECHO, TEST-PREGNANCY, TEST-BM-ASPIRATE, TEST-BM-TREPHINE |
|
| On treatment | Day 1 of every 21-day cycle | TEST-CBC, TEST-CMP, TEST-LFT |
|
| Interim response assessment | After cycles 2-4 (interim PET-CT) | TEST-PET-CT, TEST-LDH |
|
| End of treatment | After cycle 6 (within 6-8 weeks) | TEST-PET-CT, TEST-CBC, TEST-CMP, TEST-LDH |
|
| Follow-up (short-term) | Every 3 months × 2 years post-treatment | TEST-CBC, TEST-CMP, TEST-LFT, TEST-LDH |
|
| Follow-up (long-term) | Every 6 months years 3-5, then annually | TEST-CBC, TEST-LFT, TEST-ECHO |
|
| # | Owner | Topic | Action |
|---|---|---|---|
| 1 | medical_oncologist | Biomarker status BLOCKING | What is the status of Mantle Cell Lymphoma International Prognostic Index (MIPI) (BIO-MCL-MIPI)? It is required by track(s): IND-MCL-1L-BTKI-R, IND-MCL-1L-INTENSIVE. Expected value: MIPI 0-11 (low/intermediate/high) — required risk stratifier; informs intensity choice and surveillance. |
| 2 | molecular_geneticist | Biomarker status BLOCKING | What is the status of t(11;14)(q13;q32) IGH/CCND1 by FISH (BIO-T11-14-IGH-CCND1)? It is required by track(s): IND-MCL-1L-BTKI-R, IND-MCL-1L-INTENSIVE. Expected value: positive by FISH — diagnostic; required when CCND1-IHC equivocal or to confirm classical MCL. |
| 3 | pathologist | Biomarker status BLOCKING | What is the status of Cyclin D1 expression by IHC (encoded by CCND1) (BIO-CCND1-IHC)? It is required by track(s): IND-MCL-1L-BTKI-R, IND-MCL-1L-INTENSIVE. Expected value: positive (cyclin D1 nuclear staining) — diagnostic hallmark of MCL. |
| 4 | pathologist | Biomarker status BLOCKING | What is the status of CD20 expression by immunohistochemistry (BIO-CD20-IHC)? It is required by track(s): IND-MCL-1L-BTKI-R, IND-MCL-1L-INTENSIVE. Expected value: positive. |
| 5 | 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-MCL-1L-BTKI-R, IND-MCL-1L-INTENSIVE. Expected value: positive (CD5+) — part of MCL immunophenotype panel; CD5-negative MCL is rare but recognised. |
| 6 | pathologist | Pathology confirmation BLOCKING | Is CD20+ status confirmed by histology (IHC)? Without CD20+, rituximab/obinutuzumab are not indicated. |
| 7 | hematologist | Staging / disease burden | What is the current LDH? Marker of tumor burden and transformation. |
| 8 | radiologist | Staging / disease burden | Has complete staging been done (Lugano + PET/CT or CT)? |
| 9 | clinical_pharmacist | Specialist review | Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication. |
| Priority | Clinical item | Owner | Why it matters | Next action | Blocks |
|---|---|---|---|---|---|
| CRITICAL | CD20 IHC statuscd20_ihc_status | pathologist | Confirms CD20-directed therapy is biologically appropriate. | Verify CD20 IHC result, specimen, method, and report date. | - |
| CRITICAL | Lugano stagelugano_stage | radiologist | Defines lymphoma extent and supports tumor-burden and response-assessment decisions. | Document Lugano stage from PET/CT or contrast CT staging. | - |
| RECOMMENDED | LDH ratio to ULNldh_ratio_to_uln | medical_oncologist | Supports prognostic scoring and aggressive-biology flags. | Enter LDH with local upper limit of normal. | - |
| RECOMMENDED | FIB-4 liver fibrosis indexfib4_index | infectious_disease_hepatology | Screens hepatic fibrosis risk before hepatotoxic therapy or antiviral coordination. | Calculate FIB-4 from age, AST, ALT, and platelet count. | - |
| RECOMMENDED | PET/CT datepet_ct_date | radiologist | Shows whether baseline staging is recent enough for treatment planning and later response comparison. | Document baseline PET/CT date or explain alternative staging modality. | - |
| Missing biomarker | Label | MDT owner | Default track | Required by | Next action |
|---|---|---|---|---|---|
BIO-CCND1-IHC | Cyclin D1 expression by IHC (encoded by CCND1) | pathologist | yes | IND-MCL-1L-BTKI-R, IND-MCL-1L-INTENSIVE | Verify result, method, specimen, and report date before sign-off. Expected/constraint: positive (cyclin D1 nuclear staining) — diagnostic hallmark of MCL |
BIO-CD20-IHC | CD20 expression by immunohistochemistry | pathologist | yes | IND-MCL-1L-BTKI-R, IND-MCL-1L-INTENSIVE | Verify result, method, specimen, and report date before sign-off. Expected/constraint: positive |
BIO-CD5-IHC | CD5 expression by IHC / flow cytometry | pathologist | yes | IND-MCL-1L-BTKI-R, IND-MCL-1L-INTENSIVE | Verify result, method, specimen, and report date before sign-off. Expected/constraint: positive (CD5+) — part of MCL immunophenotype panel; CD5-negative MCL is rare but recognised |
BIO-MCL-MIPI | Mantle Cell Lymphoma International Prognostic Index (MIPI) | medical_oncologist | yes | IND-MCL-1L-BTKI-R, IND-MCL-1L-INTENSIVE | Verify result, method, specimen, and report date before sign-off. Expected/constraint: MIPI 0-11 (low/intermediate/high) — required risk stratifier; informs intensity choice and surveillance |
BIO-T11-14-IGH-CCND1 | t(11;14)(q13;q32) IGH/CCND1 by FISH | molecular_geneticist | yes | IND-MCL-1L-BTKI-R, IND-MCL-1L-INTENSIVE | Verify result, method, specimen, and report date before sign-off. Expected/constraint: positive by FISH — diagnostic; required when CCND1-IHC equivocal or to confirm classical MCL |
| 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) |
|---|---|---|---|---|---|---|---|
| NCT05544019 | Study of SGR-1505 in Mature B-Cell Neoplasms | PHASE1 | RECRUITING | Schrödinger, Inc. | UA
| Phase 1 only | |
| NCT06022029 | A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas. | PHASE1 | RECRUITING | OncoNano Medicine, Inc. | — | Phase 1 only | |
| NCT07377578 | A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma | PHASE3 | RECRUITING | Guangzhou Lupeng Pharmaceutical Company LTD. | — | Surrogate endpoint only Single country | |
| NCT06564038 | A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies | PHASE1 / PHASE2 | RECRUITING | AstraZeneca | — | — | |
| NCT03676504 | Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR | PHASE1 / PHASE2 | RECRUITING | University Hospital Heidelberg | — | Single country | |
| NCT06151730 | Evaluation of Hypertension Management and Cardiovascular Adverse Event Prevention in Patients With B-cell Malignancies Undergoing Treatment With Bruton Tyrosine Kinase Inhibitors, the HALT Study | N/A | RECRUITING | Mayo Clinic | — | Single country | |
| NCT04368702 | CONFIRM: Magnetic Resonance Guided Radiation Therapy | NA | RECRUITING | Brigham and Women's Hospital | — | Single country | |
| NCT06846489 | Acalabrutinib Plus Rituximab for the Treatment of Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lymphoma | PHASE2 | RECRUITING | Sun Yat-sen University | — | Single country | |
| NCT07261163 | Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma | PHASE2 | RECRUITING | Institute of Hematology & Blood Diseases Hospital, China | — | Small N (<50) Surrogate endpoint only Single country | |
| NCT07341191 | Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy | PHASE2 | RECRUITING | Canadian Cancer Trials Group | — | Small N (<50) Single country |
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 + Rituximab (continuous BTKi + R) (REG-ACALABRUTINIB-RITUXIMAB) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Aggressive plan Intensive 1L MCL: alternating R-CHOP / R-DHAP × 6 cycles + autoSCT consolidation + R maintenance (REG-MCL-INTENSIVE-RDHAP-AUTOSCT) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Trial · NCT05544019 Study of SGR-1505 in Mature B-Cell Neoplasms UA site available — verify enrollment status with site | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06022029 A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas. No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07377578 A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell 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 · NCT03676504 Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06151730 Evaluation of Hypertension Management and Cardiovascular Adverse Event Prevention in Patients With B-cell Malignancies Undergoing Treatment With Bruton Tyrosine Kinase Inhibitors, the HALT Study No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT04368702 CONFIRM: Magnetic Resonance Guided Radiation Therapy No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06846489 Acalabrutinib Plus Rituximab for the Treatment of Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lymphoma No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07261163 Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07341191 Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy 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.