OpenOnco · Treatment Plan

Treatment plan — DIS-AML

PLAN-BMA-IDH1_R132C_AML-V1 · v1 · 2026-05-04

Patient

BMA-IDH1_R132C_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-IDH-MUTATION	IDH1 R132C	IA	SRC-CIVIC: Level A (Supports, Sensitivity/Response) SRC-CIVIC: Level B ⚠ Resistance SRC-CIVIC: Level B (Supports, Better Outcome) SRC-CIVIC: Level C (Supports, Sensitivity/Response) SRC-CIVIC: Level D (Supports, Sensitivity/Response)	IDH1 R132C — same therapeutic implications as R132H; ivosidenib targets all R132 variants.	ivosidenib olutasidenib ivosidenib + azacitidine	SRC-NCCN-AML-2025 SRC-ELN-AML-2022
BIO-IDH-MUTATION	IDH1 R132G	IA	SRC-CIVIC: Level A (Supports, Sensitivity/Response) SRC-CIVIC: Level B (Supports, Better Outcome) SRC-CIVIC: Level C (Supports, Sensitivity/Response) SRC-CIVIC: Level D (Supports, Sensitivity/Response)	IDH1 R132G — covered by IDH1-mut label (any R132).	ivosidenib olutasidenib	SRC-NCCN-AML-2025
BIO-IDH-MUTATION	IDH1 R132H	IA	SRC-CIVIC: Level A (Supports, Sensitivity/Response) SRC-CIVIC: Level B (Supports, Better Outcome) SRC-CIVIC: Level C ⚠ Resistance SRC-CIVIC: Level C (Supports, Sensitivity/Response) SRC-CIVIC: Level D (Supports, Sensitivity/Response)	IDH1 R132 mutations (~6-10% of AML). Ivosidenib monotherapy (AGILE, Montesinos et al. NEJM 2022 — combo with azacitidine; AG120-C-001 — monotherapy in R/R) FDA-approved. Ivosidenib + azacitidine (1L unfit, AGILE) doubles OS vs azacitidine alone.	ivosidenib monotherapy ivosidenib + azacitidine (1L unfit) olutasidenib monotherapy ivosidenib + 7+3 (frontline fit, in trials)	SRC-NCCN-AML-2025 SRC-ELN-AML-2022 SRC-ESMO-AML-2020
BIO-IDH-MUTATION	IDH1 R132L	IA	SRC-CIVIC: Level A (Supports, Sensitivity/Response) SRC-CIVIC: Level B (Supports, Better Outcome) SRC-CIVIC: Level C (Supports, Sensitivity/Response) SRC-CIVIC: Level D (Supports, Sensitivity/Response)	IDH1 R132L — covered by IDH1-mut label.	ivosidenib olutasidenib	SRC-NCCN-AML-2025
BIO-IDH-MUTATION	IDH1 R132S	IA	SRC-CIVIC: Level A (Supports, Sensitivity/Response) SRC-CIVIC: Level B (Supports, Better Outcome) SRC-CIVIC: Level C (Supports, Sensitivity/Response) SRC-CIVIC: Level D (Supports, Sensitivity/Response)	IDH1 R132S — covered by IDH1-mut label.	ivosidenib olutasidenib	SRC-NCCN-AML-2025
BIO-IDH-MUTATION	IDH2 R140Q	IA	SRC-CIVIC: Level A (Supports, Sensitivity/Response) SRC-CIVIC: Level B ⚠ Resistance SRC-CIVIC: Level B (Supports, Better Outcome) SRC-CIVIC: Level C (Supports, Sensitivity/Response) SRC-CIVIC: Level D (Supports, Sensitivity/Response)	IDH2 R140Q (~5-9% of AML). Enasidenib (IDHIFA, AG221-C-001 Stein et al. Blood 2017) FDA-approved 2017 for R/R IDH2-mut AML. IDHENTIFY (Ph3) confirmed OS benefit late-line. Combos with azacitidine (Ph2) promising 1L unfit.	enasidenib monotherapy enasidenib + azacitidine (1L unfit, off-label/trial)	SRC-NCCN-AML-2025 SRC-ELN-AML-2022
BIO-IDH-MUTATION	IDH2 R172K	IA	SRC-CIVIC: Level A (Supports, Sensitivity/Response) SRC-CIVIC: Level B ⚠ Resistance SRC-CIVIC: Level B (Supports, Better Outcome) SRC-CIVIC: Level C (Supports, Sensitivity/Response) SRC-CIVIC: Level D (Supports, Sensitivity/Response)	IDH2 R172K — slightly different metabolic profile but same enasidenib indication.	enasidenib monotherapy enasidenib + azacitidine (1L unfit, off-label/trial)	SRC-NCCN-AML-2025 SRC-ELN-AML-2022

Treatment options (4 tracks)

Aggressive plan

★ DEFAULT

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}

Standard plan

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

Aggressive plan

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

Aggressive plan

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)

OQ-LDH-CURRENT
What is the current LDH? Marker of tumor burden and transformation.
LDH is part of the prognostic indices of indolent lymphomas.
→ hematologist

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	Domain
Cellular therapy specialist (CAR-T)	`cellular_therapy_specialist`	v0.1.0	2026-04-25	cellular_therapy
Clinical pharmacist	`clinical_pharmacist`	v0.1.0	2026-04-25	clinical_pharmacy
Hematologist / oncohematologist	`hematologist`	v0.1.0	2026-04-25	hematology_oncology
Hematopathologist (lymphoma / leukemia / myeloma)	`hematopathologist`	v0.1.0	2026-04-25	hematopathology
Infectious disease / hepatology	`infectious_disease_hepatology`	v0.1.0	2026-04-25	infectious_diseases
Medical oncologist (solid-tumor chemotherapist)	`medical_oncologist`	v0.1.0	2026-04-25	solid_oncology
Molecular geneticist / molecular oncologist	`molecular_geneticist`	v0.1.0	2026-04-25	molecular_oncology
Palliative care	`palliative_care`	v0.1.0	2026-04-25	palliative_care
Pathologist (general)	`pathologist`	v0.1.0	2026-04-25	pathology
Primary care / family physician	`primary_care`	v0.1.0	2026-04-25	primary_care
Psycho-oncologist	`psychologist`	v0.1.0	2026-04-25	psychosocial
Radiation oncologist	`radiation_oncologist`	v0.1.0	2026-04-25	radiation_oncology
Radiologist	`radiologist`	v0.1.0	2026-04-25	diagnostic_imaging
Social worker / case manager	`social_worker_case_manager`	v0.1.0	2026-04-25	psychosocial
Surgical oncologist	`surgical_oncologist`	v0.1.0	2026-04-25	surgical_oncology
Transplant specialist (BMT)	`transplant_specialist`	v0.1.0	2026-04-25	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
NCT06387069	A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukemia	PHASE3	RECRUITING	Hutchmed	—
NCT05401097	IDH Targeted/Non- Targeted vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study)	PHASE2	RECRUITING	Alice Mims	—
NCT02074839	Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation	PHASE1	RECRUITING	Institut de Recherches Internationales Servier	—

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 · NCT06387069 A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukemia No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05401097 IDH Targeted/Non- Targeted vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT02074839 Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation 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.

plan_id: PLAN-BMA-IDH1_R132C_AML-V1 | version: 1 | generated: 2026-05-04T14:13:16.608964+00:00

Per FDA non-device CDS positioning (CHARTER §15): Outpatient oncology treatment planning to support tumor-board discussion. Not a medical device; not for autonomous clinical decision-making.

Per FDA non-device CDS positioning (CHARTER §15): Both treatment options below are presented for review. The engine's selection of a 'recommended' default does not constitute a clinical decision. Final treatment selection requires HCP judgment incorporating information not available to the system.

This document is an informational resource supporting tumor-board discussion (per CHARTER §11). It is not a system that makes clinical decisions. Every recommendation must be verified by the treating physician.