OpenOnco · Treatment Plan

Treatment plan — Myelodysplastic Syndromes — Lower Risk

PLAN-MDS-LR-DEL5Q-001-V1 · v1 · 2026-07-26

Patient

MDS-LR-DEL5Q-001 · Algorithm: ALGO-MDS-LR-1L

DiagnosisMyelodysplastic Syndromes — Lower Risk

MOH / ICD-10D46.9

ICD-O-39989/3; C42.1

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
No clinically actionable variants matched in this profile.

Primary current-line option

Standard plan

★ DEFAULT

Indication

IND-MDS-LR-LENALIDOMIDE-DEL5Q

Regimen

Lenalidomide for del(5q) LR-MDS

Drugs + NSZU

Lenalidomide (DRUG-LENALIDOMIDE) 10 mg PO once daily on days 1-21 of 28-day cycle · Continuous cycles until loss of transfusion independence / progression / unacceptable toxicity · PO ✓ NSZU covered

Hard contraindications

CI-LENALIDOMIDE-PREGNANCY

Reason

Primary current-line option selected by ALGO-MDS-LR-1L at step 2; branch-driving red flag: RF-MDS-DEL-5Q-ISOLATED.

Other current-line alternatives (2 tracks)

Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.

Standard plan

Indication

IND-MDS-LR-1L-ESA

Regimen

ESA (epoetin alfa or darbepoetin) — MDS-LR symptomatic anemia 1L

Drugs + NSZU

Epoetin alfa / Darbepoetin alfa (DRUG-EPOETIN-ALFA) Epoetin alfa 60,000 IU SC weekly OR Darbepoetin 150-300 μg SC weekly (or 500 μg SC q3wk) · weekly SC; reassess at 8-12 weeks · SC ✓ NSZU covered

Reason

Current-line alternative presented for HCP consideration

Aggressive plan

Indication

IND-MDS-LR-1L-LUSPATERCEPT

Regimen

Luspatercept (MDS-LR with RS or post-ESA failure)

Drugs + NSZU

Luspatercept (DRUG-LUSPATERCEPT) 1.0 mg/kg SC q3wk; titrate to 1.33 mg/kg then 1.75 mg/kg if no transfusion-burden reduction after 2 doses · every 3 weeks SC · SC ✗ Not registered in UA

Reason

Current-line alternative presented for HCP consideration

Why this branch was chosen

Triggers from the patient profile that fired and drove the chosen branch.

Step 2 → branch IND-MDS-LR-LENALIDOMIDE-DEL5Q

RF-MDS-DEL-5Q-ISOLATED ★ winner: MDS with isolated del(5q) (or del(5q) plus one additional non-7 abnormality) — lenalidomide-responsive subgroup with ~67% RBC transfusion independence; favorable prognosis SRC-NCCN-AML-2025SRC-ESMO-MDS-2021

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-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-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-PREGNANCY	Beta-HCG	Critical	lab	—	standard
TEST-B12-FOLATE	B12 + Folate	Standard	lab	—	all tracks
TEST-ECHO	Echocardiography	Standard	imaging	—	desired (standard)
TEST-ESR-CRP	ESR + CRP	Standard	lab	—	standard
TEST-IRON-PANEL	Iron Panel	Standard	lab	—	all tracks
TEST-RETICULOCYTE	Reticulocyte Count	Standard	lab	—	all tracks

Red flags — PRO / CONTRA aggressive

PRO-AGGRESSIVE

Triggers that push toward the aggressive track

MDS with isolated del(5q) (or del(5q) plus one additional non-7 abnormality) — lenalidomide-responsive subgroup with ~67% RBC transfusion independence; favorable prognosis
Direction "investigate" — surfaces a treatment-option annotation (lenalidomide track) rather than a binary indication switch. Lenalidomide 10 mg/day × 21 days q28d achieves cytogenetic response ~50% + RBC transfusion independence ~67% in…
RF-MDS-DEL-5Q-ISOLATEDSRC-NCCN-AML-2025SRC-ESMO-MDS-2021
MDS escalates from lower-risk to higher-risk classification by IPSS-R (high / very high, >4.5 points) or IPSS-M (High / Very High) — treatment intent shifts from cytopenia management to disease modification + alloHCT bridging
Triggers shift from MDS-LR algorithm (ESA → luspatercept → lenalidomide for del 5q) to MDS-HR algorithm (HMA azacitidine 1L + alloHCT bridge in eligible patients). IPSS-M reclassifies ~46% of patients vs IPSS-R (Bernard et al. 2022) —…
RF-MDS-HIGH-RISK-IPSSSRC-NCCN-AML-2025SRC-ESMO-MDS-2021SRC-IPSS-M-BERNARD-2022
MDS with TP53 mutation (mono- or biallelic) — distinct WHO 5th-ed entity with poor outcomes on HMA monotherapy and reduced alloHCT benefit; consideration of intensified / experimental therapy or palliative intent
TP53-mutated MDS is its own WHO 5th-edition entity with median OS ~6-9 months on standard HMA. AlloHCT carries higher relapse risk vs TP53-wt. Active research questions: ven+aza vs aza alone, magrolimab + aza (failed phase-3 ENHANCE)…
RF-MDS-TP53-MUTATIONSRC-NCCN-AML-2025SRC-ESMO-MDS-2021SRC-IPSS-M-BERNARD-2022
MDS progressing to AML (≥20% blasts) or accelerated MDS-IB2 with rapid progression on HMA — switch to AML algorithm or escalate to ven+aza / intensive chemo + alloHCT bridge
≥20% blasts = AML by WHO 2022; switch to AML algorithm. HMA failure in MDS-HR has dismal prognosis (~6-month median OS without alloHCT); ven+aza or intensive chemo + alloHCT bridge are the rescue options. STUB — requires clinical co-lead…
RF-MDS-TRANSFORMATION-PROGRESSIONSRC-NCCN-AML-2025SRC-ESMO-MDS-2021

CONTRA-AGGRESSIVE

Hard contraindications to escalation

What NOT to do

Explicit prohibitive rules, each grounded in a regimen / supportive care / contraindication entity

Standard plan (IND-MDS-LR-LENALIDOMIDE-DEL5Q)

Do not prescribe without cytogenetic confirmation of del(5q) — efficacy specific to del(5q) clones.
Do not prescribe without REMS / Revlimid Risk Management Programme — drug is teratogenic; numerous birth defects have been documented.
Do not skip pregnancy testing weekly for the first month, then monthly in women of childbearing potential.
Do not prescribe concurrent ESA — additive VTE risk; choose one agent.
Do not ignore TP53-status — TP53-mutated del(5q) MDS has significantly higher risk of AML transformation on lenalidomide; consider earlier alloHCT pathway.
Do not skip VTE prophylaxis (aspirin 81-325 mg or LMWH) throughout the entire therapy.
Do not continue without response — if no TI by 6 months, stop; consider alternative (luspatercept, imetelstat).

Standard plan (IND-MDS-LR-1L-ESA)

Do not prescribe ESA at Hb >12 g/dL — boxed warning regarding thromboembolism + mortality.
Do not continue ESA in the absence of response at 8-12 weeks — switch to luspatercept (if available) / lenalidomide / HMA.
Do not skip iron studies + B12/folate before ESA — functional iron deficiency limits response.
Do not skip IPSS-R / IPSS-M risk stratification — required to exclude MDS-HR.
Do not prescribe lenalidomide without excluding del(5q) in MDS-LR — efficacy only in del(5q) context.

Aggressive plan (IND-MDS-LR-1L-LUSPATERCEPT)

Do not expect a rapid response — luspatercept requires 8-12 weeks; do not stop earlier.
Do not prescribe with uncontrolled HTN — luspatercept-induced HTN can be severe.
Do not prescribe without VTE assessment — VTE risk is elevated (especially in β-thalassemia context; also MDS).
Do not dose without weight — this is weight-based SC dosing.
Do not skip IPSS-R / IPSS-M risk stratification.

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Standard plan

Induction · Lenalidomide for del(5q) LR-MDS

28-day cycles × Continue until loss of TI / progression / unacceptable toxicity; median TI duration >2 years per MDS-004

Standard plan

Induction · ESA (epoetin alfa or darbepoetin) — MDS-LR symptomatic anemia 1L

7-day cycles × Continue if response (Hb ≥1.5 g/dL rise or transfusion-independence achieved); discontinue if no response by 12 weeks

Aggressive plan

Induction · Luspatercept (MDS-LR with RS or post-ESA failure)

21-day cycles × Continue if transfusion-burden reduction; reassess at 24 weeks

MDT brief

Discussion 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

MDT talk tree (2 steps)

#	Owner	Topic	Action
1	hematologist	Staging / disease burden	What is the current LDH? Marker of tumor burden and transformation.
2	clinical_pharmacist	Specialist review	Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.

Skills (recommended) — for consideration (1)

Clinical pharmacist recommended
Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.

Data quality

Usable with caveats. No critical default-track gap was found, but the MDT should review the listed caveats before final sign-off.

Biomarker coverage: 0/0 known (100%), 0 missing, 0 default-track gaps
Unevaluated RedFlags: RF-IPSS-M-HIGH, RF-MDS-DEL-5Q-ISOLATED, RF-MDS-FRAILTY-AGE, RF-MDS-HIGH-RISK-IPSS, RF-MDS-INFECTION-SCREENING, RF-MDS-ORGAN-DYSFUNCTION, RF-MDS-TP53-MUTATION, RF-MDS-TRANSFORMATION-PROGRESSION, RF-OCC-BENZENE-MALIGNANCY-PREVENTION

Technical MDT skill metadata (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-COMMANDS-FENAUX-2020: Luspatercept in Patients with Lower-Risk Myelodysplastic Syndromes (2020)
SRC-ESMO-MDS-2021: Myelodysplastic syndromes: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up (2021)
SRC-MDS-004-FENAUX-2011: A randomized phase 3 study of lenalidomide versus placebo in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with del5q (2011)
SRC-NCCN-AML-2025: NCCN Clinical Practice Guidelines in Oncology: Acute Myeloid Leukemia (v.X.2025)

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: 2026-07-26.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT06566742	A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.	PHASE2	RECRUITING	M.D. Anderson Cancer Center	—	Small N (<50) Single country
NCT07096297	Luspatercept + Darbepoetin in MDS	PHASE2	RECRUITING	Yale University	—	Single country
NCT05384691	Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions	PHASE2	RECRUITING	University of Leipzig	—	Single country
NCT07579429	Research On Nicotinamide Riboside Supplement Support in MDS (ROSS Trial)	PHASE2	RECRUITING	University of Colorado, Denver	—	Small N (<50) Single country
NCT05308264	Study of R289 in Patients With Lower-risk Myelodysplastic Syndromes (LR MDS)	PHASE1 / PHASE2	RECRUITING	Rigel Pharmaceuticals	—	Single country
NCT07319845	A Study of TAK-226 for Anemia in Japanese Patients With Lower-Risk Myelodysplastic Syndromes	PHASE2	RECRUITING	Takeda	—	Small N (<50) Single country
NCT06614595	Transfusion in Lower Risk MDS Patients: Predictors of Adequacy of Transfusion and Quality of Life in Lower Risk MDS	N/A	RECRUITING	Fundación para la Investigación Biosanitaria del Principado de Asturias	—	Small N (<50) Single country
NCT06304103	A Study of Efficacy and Safety of AND017 in Patients With Myelodysplastic Syndrome	PHASE2	RECRUITING	Kind Pharmaceuticals LLC	—	Single country
NCT05925504	The Tapering Dose of Luspatercept in Patients With Lower-risk Myelodysplastic Syndromes	PHASE2	RECRUITING	Institute of Hematology & Blood Diseases Hospital, China	—	Small N (<50) Single country

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
Standard plan Lenalidomide for del(5q) LR-MDS (REG-LENALIDOMIDE-MDS-DEL5Q)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Standard plan ESA (epoetin alfa or darbepoetin) — MDS-LR symptomatic anemia 1L (REG-ESA-MDS-LR)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Aggressive plan Luspatercept (MDS-LR with RS or post-ESA failure) (REG-LUSPATERCEPT-MDS-LR) 1/1 component drug(s) not registered in Ukraine +1	✗ not registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
Trial · NCT06566742 A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia. No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07096297 Luspatercept + Darbepoetin in MDS No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05384691 Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07579429 Research On Nicotinamide Riboside Supplement Support in MDS (ROSS Trial) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05308264 Study of R289 in Patients With Lower-risk Myelodysplastic Syndromes (LR MDS) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07319845 A Study of TAK-226 for Anemia in Japanese Patients With Lower-Risk Myelodysplastic Syndromes No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06614595 Transfusion in Lower Risk MDS Patients: Predictors of Adequacy of Transfusion and Quality of Life in Lower Risk MDS No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06304103 A Study of Efficacy and Safety of AND017 in Patients With Myelodysplastic Syndrome No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05925504 The Tapering Dose of Luspatercept in Patients With Lower-risk Myelodysplastic Syndromes 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: 2026-07-26.

plan_id: PLAN-MDS-LR-DEL5Q-001-V1 | version: 1 | generated: 2026-07-26T09:28:48.138229+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.