OpenOnco · Treatment Plan

Treatment plan — Hairy Cell Leukemia

PLAN-VAR-HCL-FRAIL-V1 · v1 · 2026-05-12

Patient

VAR-HCL-FRAIL · Algorithm: ALGO-HCL-1L

DiagnosisHairy Cell Leukemia

MOH / ICD-10C91.4

ICD-O-39940/3

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

Aggressive plan

★ DEFAULT

Indication

IND-HCL-1L-PENTOSTATIN

Regimen

Cladribine single 7-day course

Drugs + NSZU

Cladribine (DRUG-CLADRIBINE) 0.09 mg/kg/day continuous IV · × 7 days, single course · IV ⚠ NSZU — not for this indication

Supportive care

SUP-PJP-PROPHYLAXIS, SUP-HSV-PROPHYLAXIS

Reason

Primary current-line option selected by ALGO-HCL-1L at step 1; branch-driving red flag: RF-HCL-FRAILTY-AGE.

Other current-line alternatives (1 tracks)

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

Standard plan

Indication

IND-HCL-1L-CLADRIBINE

Regimen

Cladribine single 7-day course

Drugs + NSZU

Cladribine (DRUG-CLADRIBINE) 0.09 mg/kg/day continuous IV · × 7 days, single course · IV ⚠ NSZU — not for this indication

Supportive care

SUP-PJP-PROPHYLAXIS, SUP-HSV-PROPHYLAXIS

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 1 → branch IND-HCL-1L-PENTOSTATIN

RF-HCL-FRAILTY-AGE ★ winner: Age >75 + ECOG ≥2 OR significant comorbidity — pentostatin's weekly schedule allows finer toxicity titration than cladribine 5-7 day continuous infusion; preferred for fragile patients. SRC-NCCN-BCELL-2025SRC-ESMO-DLBCL-2024

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-CECT-CAP	CECT chest/abdomen/pelvis	Critical	imaging	—	all tracks
TEST-CMP	Comprehensive Metabolic Panel	Critical	lab	—	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	—	standard
TEST-HIV-SEROLOGY	HIV Antibody/Antigen	Critical	lab	—	standard
TEST-LFT	Liver Function Tests (ALT, AST, bilirubin, ALP, GGT, albumin)	Critical	lab	—	all tracks
TEST-PERIPHERAL-SMEAR	Peripheral Blood Smear	Critical	lab	CSD Lab ✓ (code TBC)	all tracks
TEST-NGS-LYMPHOID-PANEL	Lymphoid NGS Panel	Desired	genomic	CSD Lab ✓ (code TBC)	standard

Red flags — PRO / CONTRA aggressive

PRO-AGGRESSIVE

Triggers that push toward the aggressive track

Age >75 + ECOG ≥2 OR significant comorbidity — pentostatin's weekly schedule allows finer toxicity titration than cladribine 5-7 day continuous infusion; preferred for fragile patients.RF-HCL-FRAILTY-AGE

CONTRA-AGGRESSIVE

Hard contraindications to escalation

What NOT to do

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

Aggressive plan (IND-HCL-1L-PENTOSTATIN)

Do not prescribe in severe renal impairment without dose adjustment.
Do not skip PJP + HSV prophylaxis.

Standard plan (IND-HCL-1L-CLADRIBINE)

Do not start in active uncontrolled infection — deep CD4 lymphopenia will significantly increase the risk.
Do not skip PJP + HSV prophylaxis for ≥1 year post-treatment.
Do not skip BRAF V600E testing — required for second-line targeted therapy at relapse.
Do not treat asymptomatic HCL without cytopenia / splenomegaly indication.

Monitoring schedule

Monitoring schedule by treatment phase

Aggressive plan · MON-HCL-CLADRIBINE

Phase	Window	Tests	Checkpoints
baseline	Within 1 week before start	TEST-CBC, TEST-CMP, TEST-LFT, TEST-PERIPHERAL-SMEAR, TEST-BM-ASPIRATE, TEST-BM-TREPHINE, TEST-FLOW-CYTOMETRY, TEST-CECT-CAP	Confirm HCL: hairy cells on PB smear, BM trephine annexin-A1+, flow CD11c+CD25+CD103+CD123+ Document BRAF V600E status (informational; required for second-line targeted therapy if relapse) Treatment indication confirmed (significant cytopenia or symptomatic splenomegaly)
post_treatment_immediate	Weeks 2-4 post-cladribine	TEST-CBC	Febrile neutropenia management; transfusion support as needed
response_assessment	Month 4-6 post-cladribine	TEST-CBC, TEST-PERIPHERAL-SMEAR, TEST-BM-ASPIRATE, TEST-BM-TREPHINE, TEST-FLOW-CYTOMETRY	CR / PR / persistent disease; if persistent — repeat cladribine course or rituximab consolidation
follow_up	Every 6 months × 5 years, then annually	TEST-CBC, TEST-CMP	Surveillance for relapse (median PFS >10 years; relapse can occur) PJP + HSV prophylaxis continuing ≥1 year

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Aggressive plan

Baseline

Within 1 week before start

Induction · Cladribine single 7-day course

7-day cycles × 1 (single course; repeat only if persistent disease at 6 months)

Response assessment

Month 4-6 post-cladribine

Follow-up

Every 6 months × 5 years, then annually

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 (3 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.
3	palliative_care	Specialist review	Reduced performance status / decompensated comorbidity — goals-of-care assessment needed.

Skills (recommended) — for consideration (2)

Clinical pharmacist recommended
Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.
Palliative care recommended
Reduced performance status / decompensated comorbidity — goals-of-care assessment needed.

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-HCL-FRAILTY-AGE, RF-HCL-HIGH-RISK-BIOLOGY, RF-HCL-INFECTION-SCREENING, RF-HCL-TRANSFORMATION-PROGRESSION

Technical MDT skill metadata (2/16 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-MOZ-UA-LYMPH-2013: Уnoфікований кліnoчний протокол первинної, вторинної (спеціалізованої) медичної допомоги: Лімфоми (2013-10-30 (Наказ МОЗ України № 866))
SRC-NCCN-BCELL-2025: NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas (v.2.2025)

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: 2026-05-12.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT04322383	Binimetinib for People With Relapsed/Refractory BRAF Wild Type Hairy Cell Leukemia and Variant	PHASE2	RECRUITING	National Cancer Institute (NCI)	—	Small N (<50) Surrogate endpoint only Single country
NCT06311227	Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia	PHASE2	RECRUITING	National Cancer Institute (NCI)	—	Small N (<50) Surrogate endpoint only Single country
NCT04815356	Phase I Study of Anti-CD22 Chimeric Receptor T Cells in Patients With Relapsed/Refractory Hairy Cell Leukemia and Variant	PHASE1	RECRUITING	National Cancer Institute (NCI)	—	Phase 1 only Small N (<50) Single country
NCT02131753	Therapy Optimisation for the Treatment of Hairy Cell Leukemia	PHASE2 / PHASE3	RECRUITING	University of Giessen	—	Single country
NCT02560883	Hairy Cell Leukemia Patient Data Registry	N/A	RECRUITING	Ohio State University Comprehensive Cancer Center	—	—
NCT06774677	Decoding the Extracellular Vesicles-driven Communication in the Microenvironment of Hairy Cell Leukemia to Improve Patient Care Management	N/A	RECRUITING	IRCCS Azienda Ospedaliero-Universitaria di Bologna	—	Single country
NCT01087333	Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment	N/A	RECRUITING	National Cancer Institute (NCI)	—	Single country
NCT01137825	Registry of Older Patients With Cancer	N/A	RECRUITING	UNC Lineberger Comprehensive Cancer Center	—	Single country
NCT06764524	Hairy Cell Leukemia: Harnessing the Full Power of Extracellular Vesicles to Improve Patient Care Management	N/A	RECRUITING	IRCCS Azienda Ospedaliero-Universitaria di Bologna	—	Single country
NCT04775745	Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.	PHASE1	RECRUITING	Newave Pharmaceutical Inc	—	Phase 1 only 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
Aggressive plan Cladribine single 7-day course (REG-CLADRIBINE-SINGLE)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Standard plan Cladribine single 7-day course (REG-CLADRIBINE-SINGLE)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Trial · NCT04322383 Binimetinib for People With Relapsed/Refractory BRAF Wild Type Hairy Cell Leukemia and Variant No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06311227 Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04815356 Phase I Study of Anti-CD22 Chimeric Receptor T Cells in Patients With Relapsed/Refractory Hairy Cell Leukemia and Variant No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT02131753 Therapy Optimisation for the Treatment of Hairy Cell Leukemia No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT02560883 Hairy Cell Leukemia Patient Data Registry No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06774677 Decoding the Extracellular Vesicles-driven Communication in the Microenvironment of Hairy Cell Leukemia to Improve Patient Care Management No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT01087333 Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT01137825 Registry of Older Patients With Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06764524 Hairy Cell Leukemia: Harnessing the Full Power of Extracellular Vesicles to Improve Patient Care Management No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04775745 Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies. 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: 2026-05-12.

plan_id: PLAN-VAR-HCL-FRAIL-V1 | version: 1 | generated: 2026-05-12T18:41:26.404460+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.