Patient
BMA-KMT2A_REARR_AML · Algorithm: ALGO-AML-1L
Clinical significance of mutations (ESCAT)
Tumor-board context — the engine does not use these tiers to rank tracks
| Biomarker | Variant | ESCAT | Evidence | Clinical significance | Drugs | Sources |
|---|
| BIO-KMT2A-REARRANGEMENT | KMT2A (MLL) rearrangement — any fusion partner (KMT2A-MLLT3/AF9, KMT2A-MLLT4/AF6, KMT2A-ELL, KMT2A-MLLT1/ENL, KMT2A-AF1Q, KMT2A-AFDN among others; detected by FISH, RNA-seq, or cytogenetics) | IA | - SRC-NCCN-AML-2025: Level Category 2A (Supports, Sensitivity/Response)
- SRC-ELN-AML-2022: Level B (Supports, Sensitivity/Response)
| Revumenib (SNDX-5613), an oral menin inhibitor, is FDA-approved (Nov 2024) for relapsed/refractory KMT2A-rearranged acute leukemia (AML and ALL). AUGMENT-101 (Issa et al. NEJM 2023; Erba et al. ASH 2023 update): KMT2A-rearranged R/R AML/ALL — ORR 23% (CR + CRh + CRi), complete remission with full recovery 18%; mOS 8.0 mo. FDA accelerated approval based on remission rate as surrogate endpoint. KMT2A rearrangement is present in ~10% of adult AML (more common in secondary/therapy-related AML and infant leukemia). Menin is an essential co-factor of KMT2A-fusion oncoproteins — revumenib disrupts menin-MLL interaction, restoring differentiation block. Combination strategies under evaluation: revumenib + venetoclax + azacitidine (phase II ongoing). ELN 2022 risk: KMT2A-rearranged AML classified as intermediate risk (specific partner-dependent — MLLT3 intermediate; others may be adverse). | revumenib 163 mg PO BID (with strong CYP3A4 inhibitor: 95 mg BID) monotherapy — R/R KMT2A-rearranged AML post ≥2 prior lines
revumenib + venetoclax + azacitidine (investigational; phase II enrollment ongoing as of 2026) | - SRC-NCCN-AML-2025
- SRC-ELN-AML-2022
|
Treatment options (4 tracks)
- Indication
- IND-AML-1L-7-3
- Regimen
- 7+3 Induction (cytarabine + daunorubicin/idarubicin) ± midostaurin
- Drugs + NSZU
- Cytarabine (DRUG-CYTARABINE) 100-200 mg/m²/day · continuous IV infusion days 1-7 · IV ✓ NSZU covered
- Daunorubicin (DRUG-DAUNORUBICIN) 60-90 mg/m² (or idarubicin 12 mg/m² as alternative) · IV bolus days 1-3 · IV ✓ NSZU covered
- Midostaurin (DRUG-MIDOSTAURIN) 50 mg PO BID — ONLY if FLT3-ITD/TKD positive · days 8-21 of induction (and continuation through consolidation + maintenance) · PO ⚠ NSZU — not for this indication
- Supportive care
- SUP-TLS-PROPHYLAXIS, SUP-PJP-PROPHYLAXIS, SUP-HSV-PROPHYLAXIS, SUP-HBV-PROPHYLAXIS
- Reason
- Engine default per algorithm ALGO-AML-1L: {'step': 7, 'outcome': False, 'branch': {'result': 'IND-AML-1L-7-3'}, 'fired_red_flags': [], 'winner_red_flag': None}
- Indication
- IND-AML-1L-VEN-AZA
- Regimen
- Venetoclax + Azacitidine (AML, unfit) — VIALE-A schedule
- Drugs + NSZU
- Venetoclax (DRUG-VENETOCLAX) Cycle 1 ramp: day 1 = 100 mg, day 2 = 200 mg, day 3 = 400 mg → days 4-28 = 400 mg PO daily; subsequent cycles = 400 mg daily continuously · PO daily; reduce to ~70-100 mg if combined with strong CYP3A4 inhibitor (posaconazole) · PO ⚠ NSZU — not for this indication
- Azacitidine (DRUG-AZACITIDINE) 75 mg/m²/day · SC or IV days 1-7 of each 28-day cycle · SC ⚠ NSZU — not for this indication
- Supportive care
- SUP-TLS-PROPHYLAXIS, SUP-PJP-PROPHYLAXIS, SUP-HSV-PROPHYLAXIS, SUP-HBV-PROPHYLAXIS
- Reason
- Alternative track presented for HCP consideration
- Indication
- IND-AML-1L-7-3-GO-CBF
- Regimen
- 7+3 + fractionated gemtuzumab ozogamicin (CD33+ AML, 1L; ALFA-0701)
- Drugs + NSZU
- Cytarabine (DRUG-CYTARABINE) 100-200 mg/m²/day · Continuous IV infusion days 1-7 · IV ✓ NSZU covered
- Daunorubicin (DRUG-DAUNORUBICIN) 60 mg/m² (per ALFA-0701; 90 mg/m² acceptable when GO not added per ECOG-ACRIN — but 60 mg/m² standard with concurrent GO due to additive cardiotoxicity / mortality concern) · IV bolus days 1-3 · IV ✓ NSZU covered
- Gemtuzumab ozogamicin (DRUG-GEMTUZUMAB-OZOGAMICIN) 3 mg/m² (max 4.5 mg total per dose) IV — fractionated · Days 1, 4, 7 of induction · IV ✗ Not registered in UA
- Supportive care
- SUP-TLS-PROPHYLAXIS, SUP-PJP-PROPHYLAXIS, SUP-HSV-PROPHYLAXIS, SUP-HBV-PROPHYLAXIS
- Hard contraindications
- CI-LVEF-LOW-FOR-ANTHRACYCLINE
- Reason
- Alternative track presented for HCP consideration
- Indication
- IND-AML-1L-CPX351-SECONDARY
- Regimen
- CPX-351 (Vyxeos) for tAML / AML-MRC 1L
- Drugs + NSZU
- Liposomal cytarabine-daunorubicin (DRUG-CPX-351) Induction 100 units/m² IV (= cytarabine 100 mg/m² + daunorubicin 44 mg/m²) days 1, 3, 5 · Cycle 1; re-induction days 1, 3 if needed · IV ✗ Not registered in UA
- Liposomal cytarabine-daunorubicin (DRUG-CPX-351) Consolidation 65 units/m² IV days 1, 3 · Up to 2 consolidation cycles, every 5-8 weeks after count recovery · IV ✗ Not registered in UA
- Supportive care
- SUP-TLS-PROPHYLAXIS, SUP-PJP-PROPHYLAXIS, SUP-HSV-PROPHYLAXIS, SUP-HBV-PROPHYLAXIS
- Hard contraindications
- CI-LVEF-LOW-FOR-ANTHRACYCLINE
- Reason
- Alternative track presented for HCP consideration
Pre-treatment investigations
Investigations before treatment start · critical / standard / desired · merged across tracks
| ID | Name | Priority | Category | Where to order | Needed for |
|---|
| TEST-BM-ASPIRATE | Bone Marrow Aspirate | Critical | histology | — | all tracks |
| TEST-BM-TREPHINE | Bone Marrow Trephine | Critical | histology | — | all tracks |
| TEST-CBC | Complete Blood Count with Differential | Critical | lab | — | all tracks |
| TEST-CMP | Comprehensive Metabolic Panel | Critical | lab | — | all tracks |
| TEST-COAG-PANEL | Coagulation Panel | Critical | lab | — | all tracks |
| TEST-FISH-PANEL | FISH (Fluorescence In Situ Hybridization) | Critical | genomic | CSD Lab ✓ (code TBC) | all tracks |
| TEST-FLOW-CYTOMETRY | Flow Cytometry | Critical | histology | 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-KARYOTYPE | Karyotype | Critical | genomic | CSD Lab ✓ (code TBC) | 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-NGS-MYELOID-PANEL | Myeloid NGS Panel | Critical | genomic | CSD Lab ✓ (code TBC) | all tracks |
| TEST-PERIPHERAL-SMEAR | Peripheral Blood Smear | Critical | lab | CSD Lab ✓ (code TBC) | all tracks |
| TEST-PREGNANCY | Beta-HCG | Critical | lab | — | aggressive |
| TEST-CMV-SEROLOGY | CMV IgG/IgM | Standard | lab | — | aggressive |
| TEST-ECHO | Echocardiography | Standard | imaging | — | aggressive |
| TEST-URIC-ACID | Serum Uric Acid | Standard | lab | — | all tracks |
| TEST-D-DIMER | D-Dimer | Desired | lab | — | aggressive |
Red flags — PRO / CONTRA aggressive
PRO-AGGRESSIVE
Triggers that push toward the aggressive track
- AML with core-binding-factor (CBF) cytogenetics: t(8;21)(q22;q22.1) with RUNX1::RUNX1T1 fusion OR inv(16)(p13.1q22) / t(16;16)(p13.1;q22) with CBFB::MYH11 fusion. ~10-15% of de novo adult AML, ~25% of pediatric AML. ELN 2022 favorable risk; standard 7+3 induction + 3-4 cycles HiDAC consolidation is curative-intent in CR1 (5-year OS 60-75%); upfront alloHCT is NOT recommended in CR1 default. Adding gemtuzumab ozogamicin to induction (ALFA-0701, AML-19) further improves OS specifically in CBF AML (HR 0.69). c-KIT mutations (D816, exon-8) co-occur in ~25% of CBF AML and may downgrade favorability — warrant MRD-directed approach.
RF-AML-CORE-BINDING-FACTOR-FAVORABLE
- AML emergency triad: hyperleukocytosis (WBC ≥100 K/μL), tumor lysis syndrome (LDH >2× ULN, uric acid >7.5 mg/dL, K+ rising, phosphate rising, Ca2+ falling), or symptomatic leukostasis (dyspnea, altered mental status, retinal hemorrhage)RF-AML-EMERGENCY-TLS-LEUKOSTASIS
- AML with FLT3-ITD or FLT3-TKD mutation — addition of midostaurin (or gilteritinib in r/r) to induction is required (RATIFY trial)RF-AML-FLT3-ACTIONABLE
- AML with adverse-risk biology per ELN 2022: TP53 mutation, complex / monosomal karyotype, RUNX1 / ASXL1 mutation, KMT2A rearrangement (other than t(9;11)), inv(3) / t(3;3), -5/del(5q), -7, FLT3-ITD without NPM1, or therapy-relatedRF-AML-HIGH-RISK-BIOLOGY
- AML patient with positive HBV / HCV / HIV serology, latent TB, or active uncontrolled infection — needs antiviral prophylaxis (HBV-active prophylaxis with entecavir/tenofovir; HCV expert consult; ART optimization for HIV; TB treatment) before inductionRF-AML-INFECTION-SCREENING
- NPM1 mutation (most commonly type-A: c.860_863dupTCTG / p.W288fs) in AML — ~30% of adult AML; ~50% of cytogenetically normal AML. ELN-2022 favorable risk when NPM1-mutated WITHOUT FLT3-ITD; standard 7+3 induction first-line (no upfront alloHCT in CR1; consolidation HiDAC × 3-4 cycles is curative-intent). MRD qPCR (NPM1-mut transcript) for monitoring.
RF-AML-NPM1-MUT-FAVORABLE
- AML eligible for CPX-351 (Vyxeos) liposomal cytarabine+daunorubicin per the FDA-approved subset: therapy-related AML (t-AML, post-cytotoxic / post-radiation), AML with myelodysplasia-related changes (AML-MRC) per WHO criteria (multilineage dysplasia OR MDS-related cytogenetics OR antecedent MDS/CMML). Phase-3 Lancet 2018 (Lancet 2018;392:2088; Lancet Haematology 2020;7:e552 5-yr follow-up): mOS 9.56 vs 5.95 mo for 7+3, HR 0.69; 5-yr OS 18% vs 8%. Eligibility window age 60-75 + fit-for-intensive-chemo. Routes 1L AML to CPX-351-SECONDARY indication over standard 7+3 when this RF fires.
RF-AML-SECONDARY-AML-MRC-CPX351-ELIGIBLE
- AML refractory or relapsed: <5% blast clearance after induction, or relapse after CR (early relapse <6 mo, late relapse ≥6 mo). Switch to salvage chemotherapy (FLAG-IDA, MEC) ± targeted (FLT3+: gilteritinib; IDH+: ivosidenib/enasidenib) + alloHCT bridgeRF-AML-TRANSFORMATION-PROGRESSION
CONTRA-AGGRESSIVE
Hard contraindications to escalation
- Pre-treatment LVEF <50% is an absolute contraindication to anthracycline-containing regimens (R-CHOP, Pola-R-CHP, ABVD, BV-AVD, etc.). Cardiotoxicity from doxorubicin is dose-cumulative and often irreversible; starting with already-impaired function risks acute decompensation.CI-LVEF-LOW-FOR-ANTHRACYCLINE
- Pre-treatment LVEF <50% is an absolute contraindication to anthracycline-containing regimens (R-CHOP, Pola-R-CHP, ABVD, BV-AVD, etc.). Cardiotoxicity from doxorubicin is dose-cumulative and often irreversible; starting with already-impaired function risks acute decompensation.CI-LVEF-LOW-FOR-ANTHRACYCLINE
What NOT to do
Explicit prohibitive rules, each grounded in a regimen / supportive care / contraindication entity
Aggressive plan (IND-AML-1L-7-3)
- Do not start induction without baseline echo / LVEF if there is any cardiac suspicion — cumulative anthracycline cardiotoxicity can be fatal.
- Do not wait for FLT3 results to start d1-d7 cytarabine + anthracycline — midostaurin starts on day 8, so induction is not delayed.
- Do not skip TLS prophylaxis (allopurinol ± rasburicase) in patients with high WBC or high tumor activity.
- Do not skip HBV/HCV/HIV screening before induction — HBV reactivation on chemotherapy can be fatal.
- Do not prescribe without discussing fertility in young patients — anabolic-induced gonadotoxicity is often irreversible.
- Do not start without a validated donor search for ELN-adverse-risk patients — the alloHCT window closes quickly.
Standard plan (IND-AML-1L-VEN-AZA)
- Do not skip the 3-day venetoclax ramp + TLS prophylaxis — fatal TLS cases described when skipping the ramp.
- Do not use full-dose venetoclax (400 mg) with a strong CYP3A4 inhibitor (azole) — reduction to ~70-100 mg required.
- Do not skip HBV screening + prophylaxis — reactivation on HMA + venetoclax described.
- Do not expect a rapid response — azacitidine requires 4-6 cycles; do not stop earlier without progression.
- Do not skip G-CSF in febrile neutropenia — cumulative cytopenias expected; antimicrobial prophylaxis is mandatory.
Aggressive plan (IND-AML-1L-7-3-GO-CBF)
- Do not add GO in adverse-risk AML (TP53-mutant, complex karyotype, monosomy 7) — no benefit + toxicity persists.
- Do not use daunorubicin 90 mg/m² with GO — cardiotoxicity + early mortality signal in SWOG-S0106 was specifically due to this combination.
- Do not add GO without CD33 validation — CD33-flow ≥20% blasts required; CD33-low/negative AML — no benefit signal.
- Do not give GO within 90 days before planned alloHCT — VOD/SOS risk in the post-transplant window is dramatically increased.
- Do not skip baseline LFT + daily monitoring of bilirubin / weight gain during GO — VOD/SOS is the dominant safety concern.
- Do not skip ECHO — anthracycline cardiotoxicity + GO-specific cardiac signal require LVEF tracking.
- Do not skip TLS prophylaxis + HBV/HCV/HIV screening — standard 7+3 vigilance.
Aggressive plan (IND-AML-1L-CPX351-SECONDARY)
- Do NOT use CPX-351 in patients with de novo AML without MRC-features — FDA approval is narrow: only tAML / AML-MRC / antecedent MDS-CMML.
- Do NOT mix or substitute with free cytarabine + daunorubicin — fatal dosing errors documented (units/m² vs mg/m²).
- Do NOT prescribe with LVEF <50% — liposomal anthracycline is still cardiotoxic.
- Do NOT skip pre-cycle ECHO + cumulative-anthracycline tracking.
- Do NOT start without alloHCT-pathway planning — survival benefit predominantly via bridge to HCT.
- Do NOT stop on delayed recovery (>day 35) — this is expected for the liposomal formulation; G-CSF + transfusion support.
- Do NOT skip TLS prophylaxis in high WBC or high tumor activity.
Timeline
Treatment timeline — derived from regimen + monitoring schedule
Aggressive plan
Induction · 7+3 Induction (cytarabine + da
28-day cycles × 1 induction (re-induction if not in CR after day 14 BM); then 3-4 consolidation HiDAC cycles for younger fit; alloHCT for adverse-risk or post-CR1 in adverse / intermediate
Standard plan
Induction · Venetoclax + Azacitidine (AML,
28-day cycles × Continue until progression / unacceptable toxicity (median ~12 cycles in VIALE-A; ~25-30% achieve durable remission)
Aggressive plan
Induction · 7+3 + fractionated gemtuzumab
28-day cycles × 1 induction; consolidation HiDAC × 3-4 cycles ± additional fractionated GO 3 mg/m² day 1 of consolidation cycles 1-2 (per ALFA-0701 protocol). No upfront alloHCT in CR1 for favorable-risk per ELN 2022.
Aggressive plan
Induction · CPX-351 (Vyxeos) for tAML / AM
35-day cycles × 1-2 induction + up to 2 consolidation; alloHCT in CR1 if eligible
MDT brief
Skills (recommended) — for consideration (1)
- Clinical pharmacist recommended
Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.
skill: clinical_pharmacistv0.1.0reviewed 2026-04-25STUBsign-offs: 0lead: TBD
Open questions (1, 0 blocking)
Data quality
- Unevaluated RedFlags: RF-AML-CD33-POS-GO-CANDIDATE, RF-AML-CORE-BINDING-FACTOR-FAVORABLE, RF-AML-EMERGENCY-TLS-LEUKOSTASIS, RF-AML-FLT3-ACTIONABLE, RF-AML-FRAILTY-AGE, RF-AML-HIGH-RISK-BIOLOGY, RF-AML-IDH1-MUT-ACTIONABLE, RF-AML-IDH2-MUT-ACTIONABLE, RF-AML-INFECTION-SCREENING, RF-AML-KMT2A-ACTIONABLE, RF-AML-MEASURABLE-RESIDUAL-DISEASE, RF-AML-NPM1-MUT-FAVORABLE, RF-AML-ORGAN-DYSFUNCTION, RF-AML-SECONDARY-AML-MRC-CPX351-ELIGIBLE, RF-AML-TP53-ADVERSE, RF-AML-TRANSFORMATION-PROGRESSION
Skill catalog (1/16 activated in this plan)
All registered virtual specialists. ✓ — activated for this case; ○ — not activated (available for other clinical scenarios).
| 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 |
Sources cited
- SRC-ALFA-0701-CASTAIGNE-2012: Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study (2012)
- SRC-ELN-AML-2022: Diagnosis and management of AML in adults: 2022 ELN recommendations from an international expert panel (2022)
- SRC-LANCET-CPX351-2018: CPX-351 (cytarabine and daunorubicin) Liposome for Injection vs Conventional Cytarabine Plus Daunorubicin in Older Patients With Newly Diagnosed Secondary AML (2018)
- SRC-NCCN-AML-2025: NCCN Clinical Practice Guidelines in Oncology: Acute Myeloid Leukemia (v.X.2025)
- SRC-RATIFY-STONE-2017: Midostaurin plus Chemotherapy for Acute Myeloid Leukemia with a FLT3 Mutation (2017)
- SRC-VIALE-A-DINARDO-2020: Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia (2020)
Experimental options (clinical trials)
Third plan track — open-enrollment trials from ClinicalTrials.gov. Render-time metadata; engine selection is not affected by this block (CHARTER §8.3). Last synced: 2026-05-04.
| NCT | Title | Phase | Status | Sponsor | UA | Eligibility (excerpt) |
|---|
| NCT04065399 | A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation | PHASE1 / PHASE2 | RECRUITING | — | |
| NCT06440135 | Ziftomenib Maintenance Post Allo-HCT | PHASE1 | RECRUITING | — | |
| NCT07537738 | Leukemia Stem Cell-based Assay to Predict Relapse and Survival in Patients With Acute Myeloid Leukemia | N/A | RECRUITING | — | |
| NCT06222580 | SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation | PHASE1 | RECRUITING | — | |
| NCT04988555 | A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1) | PHASE1 / PHASE2 | RECRUITING | — | |
| NCT06001788 | Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia | PHASE1 | RECRUITING | — | |
| NCT07155226 | Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression | PHASE1 / PHASE2 | RECRUITING | — | |
Verify recruitment status directly with the trial site. ctgov data can lag behind current UA-site status.
Option availability in Ukraine
Per-track UA registration · NSZU · cost · access pathway. Render-time metadata; engine selection does not depend on these fields (CHARTER §8.3).
| Option | UA registration | NSZU | Cost orientation | Access pathway |
|---|
| Aggressive plan 7+3 Induction (cytarabine + daunorubicin/idarubicin) ± midostaurin (REG-AML-7-3) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Standard plan Venetoclax + Azacitidine (AML, unfit) — VIALE-A schedule (REG-VEN-AZA-AML) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Aggressive plan 7+3 + fractionated gemtuzumab ozogamicin (CD33+ AML, 1L; ALFA-0701) (REG-AML-7-3-GO) 1/3 component drug(s) not registered in Ukraine +1 | ✗ not registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
| Aggressive plan CPX-351 (Vyxeos) for tAML / AML-MRC 1L (REG-CPX351-AML) 2/2 component drug(s) not registered in Ukraine +1 | ✗ not registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
| Trial · NCT04065399 A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06440135 Ziftomenib Maintenance Post Allo-HCT No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07537738 Leukemia Stem Cell-based Assay to Predict Relapse and Survival in Patients With Acute Myeloid Leukemia No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06222580 SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT04988555 A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1) No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06001788 Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07155226 Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression 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: 2026-05-04.