OpenOnco · PTCL NOS · Relapsed post-autoSCT (Romidepsin / Pralatrexate)
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OpenOnco · Treatment Plan
Treatment plan — Peripheral T-Cell Lymphoma, NOS
PLAN-PTCL-RELAPSED-001-V1 · v1 · 2026-06-11
Patient
PTCL-RELAPSED-001 · Algorithm: ALGO-PTCL-2L
DiagnosisPeripheral T-Cell Lymphoma, NOS
MOH / ICD-10C84.4
ICD-O-39702/3

Clinical significance of mutations (ESCAT)

Tumor-board context — the engine does not use these tiers to rank tracks
✅ Covered biomarkers (matched in KB)
BiomarkerVariantESCATEvidenceClinical significanceDrugsSources
No clinically actionable variants matched in this profile.
⚠️ Not included in plan
BiomarkerStatus
BIO-CD30-IHCExcluded (negative)

Primary current-line option

Standard plan
★ DEFAULT
Indication
IND-PTCL-2L-ROMIDEPSIN
Regimen
Romidepsin IV days 1, 8, 15 q28d — r/r PTCL incl AITL
Drugs + NSZU
  • Romidepsin (DRUG-ROMIDEPSIN) 14 mg/m² IV over 4 hours · Days 1, 8, 15 of each 28-day cycle, until progression or unacceptable toxicity · IV ✗ Not registered in UA
Supportive care
SUP-PJP-PROPHYLAXIS, SUP-TLS-PROPHYLAXIS, SUP-ANTIEMETIC-PREMED
Reason
Primary current-line option selected by ALGO-PTCL-2L at step 2.

Other current-line alternatives (1 tracks)

Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.
Standard plan
Indication
IND-PTCL-2L-PRALATREXATE
Regimen
Pralatrexate 30 mg/m² IV weekly × 6 of 7-week cycle (PROPEL schedule) — r/r PTCL
Drugs + NSZU
  • Pralatrexate (DRUG-PRALATREXATE) 30 mg/m² IV push over 3-5 min · Weekly × 6 of each 7-week cycle, until progression or unacceptable toxicity · IV ✗ Not registered in UA
  • Leucovorin (DRUG-LEUCOVORIN) 1 mg PO daily (folate) · Continuous throughout therapy + 30 days post-final dose · PO ⚠ NSZU — not for this indication
Supportive care
SUP-PJP-PROPHYLAXIS, SUP-TLS-PROPHYLAXIS, SUP-ANTIEMETIC-PREMED
Reason
Current-line alternative presented for HCP consideration

Pre-treatment investigations

Investigations before treatment start · critical / standard / desired · merged across tracks
IDNamePriorityCategoryWhere to orderNeeded for
TEST-BM-ASPIRATEBone Marrow AspirateCriticalhistologyall tracks
TEST-CBCComplete Blood Count with DifferentialCriticallaball tracks
TEST-CD20-IHCCD20 ImmunohistochemistryCriticalhistologyCSD Lab ✓ (code TBC)all tracks
TEST-CMPComprehensive Metabolic PanelCriticallaball tracks
TEST-HBV-SEROLOGYHepatitis B Serology Panel (HBsAg, anti-HBc total, anti-HBs)Criticallaball tracks
TEST-HCV-ANTIBODYHCV AntibodyCriticallaball tracks
TEST-HIV-SEROLOGYHIV Antibody/AntigenCriticallaball tracks
TEST-LDHLactate DehydrogenaseCriticallaball tracks
TEST-LFTLiver Function Tests (ALT, AST, bilirubin, ALP, GGT, albumin)Criticallaball tracks
TEST-PREGNANCYBeta-HCGCriticallaball tracks
TEST-RENAL-FUNCTION-EGFRRenal function with eGFRCriticallaball tracks
TEST-B2-MICROGLOBULINBeta-2 MicroglobulinStandardlaball tracks
TEST-LN-CORE-BIOPSYCore LN BiopsyStandardhistologyall tracks
TEST-PET-CTFDG PET/CT (whole body)Standardimagingall tracks

What NOT to do

Explicit prohibitive rules, each grounded in a regimen / supportive care / contraindication entity
Standard plan (IND-PTCL-2L-ROMIDEPSIN)
  • Do NOT skip baseline + serial QTc + correct K/Mg to upper-normal range before infusion — romidepsin has cardiac signal.
  • Do NOT combine with QT-prolonging drugs without strict monitoring.
  • Do NOT combine with warfarin without modified INR monitoring — INR rises substantially.
  • Do NOT prescribe with concomitant strong CYP3A inhibitor without dose reduction.
  • Do NOT skip TLS prophylaxis in high-burden disease.
  • Do NOT forget the plan to alloSCT consolidation in fit transplant-eligible responders — HDACi not curative; bridge.
  • Do NOT prescribe without funding pathway clarification — drug not registered in Ukraine.
  • Do NOT mistake intra-infusion ECG ST/T changes (typically benign) for ischemic — baseline + serial ECGs.
Standard plan (IND-PTCL-2L-PRALATREXATE)
  • Do NOT prescribe without MANDATORY folate 1 mg PO daily (start 10 days pre-treatment) + B12 1 mg IM q8-10 weeks throughout therapy — sharply reduces mucositis.
  • Do NOT skip oral cryotherapy (ice chips / cold water gargle) during infusion — additionally reduces mucositis.
  • Do NOT combine with TMP-SMX prolonged use (PJP prophylaxis) without strict monitoring — additive antifolate toxicity; consider alternative PJP agent.
  • Do NOT combine with NSAIDs — reduce pralatrexate clearance, increase toxicity.
  • Do NOT prescribe at CrCl <30 without dose reduction / alternative — primarily renal clearance.
  • Do NOT continue at Grade ≥3 mucositis preventing PO intake — hold + mitigate + reduce dose to 20 mg/m² on resume.
  • Do NOT forget the plan to alloSCT consolidation in fit transplant-eligible responders — pralatrexate not curative; bridge.
  • Do NOT prescribe without funding pathway — drug not registered in Ukraine and not EMA-approved.

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Standard plan

Induction · Romidepsin IV days 1, 8, 15 q28d — r/r PTCL incl AITL
28-day cycles × Until progression or unacceptable toxicity (response-driven)

Standard plan

Induction · Pralatrexate 30 mg/m² IV weekly × 6 of 7-week cycle (PROPEL schedule) — r/r PTCL
49-day cycles × Until progression or unacceptable toxicity

MDT brief

Discussion questions (3, 2 blocking)

MDT talk tree (4 steps)

#OwnerTopicAction
1infectious_disease_hepatologyInfection / hepatic safety BLOCKINGHas HBV serology (HBsAg, anti-HBc total) been done? Status must be known before starting anti-CD20 therapy.
2pathologistPathology confirmation BLOCKINGIs CD20+ status confirmed by histology (IHC)? Without CD20+, rituximab/obinutuzumab are not indicated.
3radiologistStaging / disease burden Has complete staging been done (Lugano + PET/CT or CT)?
4hematologistSpecialist review Lymphoma diagnosis — leading specialty for treatment management.

Skills (required) — mandatory virtual specialists (1)

  • Hematologist / oncohematologist required
    Lymphoma diagnosis — leading specialty for treatment management.

Skills (recommended) — for consideration (1)

  • Pathologist (general) recommended
    Confirm lymphoma histology + assess transformation risk (DLBCL/Richter).
    Owns: OQ-CD20-CONFIRMATION

Data quality

Incomplete for MDT sign-off. MDT sign-off is incomplete until critical clinical data gaps are resolved.
  • Biomarker coverage: 0/0 known (100%), 0 missing, 0 default-track gaps
  • Missing critical: cd20_ihc_status, hbsag blocks: RF-PTCL-NOS-INFECTION-SCREENING, anti_hbc_total blocks: RF-PTCL-NOS-INFECTION-SCREENING, lugano_stage
  • Missing recommended: ldh_ratio_to_uln, fib4_index, pet_ct_date
  • Unevaluated RedFlags: RF-PTCL-NOS-FRAILTY-AGE, RF-PTCL-NOS-INFECTION-SCREENING, RF-PTCL-NOS-ORGAN-DYSFUNCTION, RF-PTCL-NOS-TRANSFORMATION-PROGRESSION, RF-TCELL-CD30-POSITIVE

Missing data for doctor action

PriorityClinical itemOwnerWhy it mattersNext actionBlocks
CRITICALCD20 IHC status
cd20_ihc_status
pathologistConfirms CD20-directed therapy is biologically appropriate.Verify CD20 IHC result, specimen, method, and report date.-
CRITICALHBsAg
hbsag
infectious_disease_hepatologyIdentifies active HBV infection and prophylaxis need before anti-CD20 or other immunosuppressive therapy.Order or document HBsAg before treatment start.RF-PTCL-NOS-INFECTION-SCREENING
CRITICALTotal anti-HBc
anti_hbc_total
infectious_disease_hepatologyDetects prior HBV exposure and reactivation risk.Order or document total anti-HBc and decide prophylaxis/monitoring.RF-PTCL-NOS-INFECTION-SCREENING
CRITICALLugano stage
lugano_stage
radiologistDefines lymphoma extent and supports tumor-burden and response-assessment decisions.Document Lugano stage from PET/CT or contrast CT staging.-
RECOMMENDEDLDH ratio to ULN
ldh_ratio_to_uln
medical_oncologistSupports prognostic scoring and aggressive-biology flags.Enter LDH with local upper limit of normal.-
RECOMMENDEDFIB-4 liver fibrosis index
fib4_index
infectious_disease_hepatologyScreens hepatic fibrosis risk before hepatotoxic therapy or antiviral coordination.Calculate FIB-4 from age, AST, ALT, and platelet count.-
RECOMMENDEDPET/CT date
pet_ct_date
radiologistShows whether baseline staging is recent enough for treatment planning and later response comparison.Document baseline PET/CT date or explain alternative staging modality.-
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).
Specialistskill_idVersionLast reviewedSign-offsDomain
Cellular therapy specialist (CAR-T)cellular_therapy_specialistv0.1.02026-04-250cellular_therapy
Clinical pharmacistclinical_pharmacistv0.1.02026-04-250clinical_pharmacy
Hematologist / oncohematologisthematologistv0.1.02026-04-250hematology_oncology
Hematopathologist (lymphoma / leukemia / myeloma)hematopathologistv0.1.02026-04-250hematopathology
Infectious disease / hepatologyinfectious_disease_hepatologyv0.1.02026-04-250infectious_diseases
Medical oncologist (solid-tumor chemotherapist)medical_oncologistv0.1.02026-04-250solid_oncology
Molecular geneticist / molecular oncologistmolecular_geneticistv0.1.02026-04-250molecular_oncology
Palliative carepalliative_carev0.1.02026-04-250palliative_care
Pathologist (general)pathologistv0.1.02026-04-250pathology
Primary care / family physicianprimary_carev0.1.02026-04-250primary_care
Psycho-oncologistpsychologistv0.1.02026-04-250psychosocial
Radiation oncologistradiation_oncologistv0.1.02026-04-250radiation_oncology
Radiologistradiologistv0.1.02026-04-250diagnostic_imaging
Social worker / case managersocial_worker_case_managerv0.1.02026-04-250psychosocial
Surgical oncologistsurgical_oncologistv0.1.02026-04-250surgical_oncology
Transplant specialist (BMT)transplant_specialistv0.1.02026-04-250cellular_therapy

Sources cited

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: 2026-06-11.
NCTTitlePhaseStatusSponsorUASignalsEligibility (excerpt)
NCT05770037DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage/Young Adult Patients With ALK Positive CancersPHASE2 / PHASE3RECRUITINGCancer Research UKSmall N (<50) Surrogate endpoint only Single country
NCT07162012Safety and Efficacy of Anti-EBV Autologous TCR-T Cell Injection in Relapsed/Refractory EBV-Positive LymphomaEARLY_PHASE1RECRUITINGShanghai General Hospital, Shanghai Jiao Tong University School of MedicineSmall N (<50) Single country
NCT06630091A Phase II, Single-center, Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib in the Management of Newly Diagnosed Peripheral T Cell Lymphoma Patients (GOLDEN Study) and Correlative StudyPHASE2RECRUITINGM.D. Anderson Cancer CenterSmall N (<50) Single country
NCT07093710Golidocitinib Combined With Mitoxantrone Hydrochloride Liposome or Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell LymphomaPHASE1 / PHASE2RECRUITINGSun Yat-sen UniversitySurrogate endpoint only Single country
NCT04747236Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCLPHASE2RECRUITINGUniversity of VirginiaSurrogate endpoint only Single country
NCT04512534Sintilimab Combined With Chidamide in Treating Peripheral T Cell LymphomaPHASE2RECRUITINGFudan UniversitySurrogate endpoint only Single country
NCT07389616A Clinical Trial of Cidabenamine Plus Azacitidine to Prevent Post-Transplant Progression in High-Risk Peripheral T-Cell LymphomaPHASE2 / PHASE3RECRUITINGShanghai General Hospital, Shanghai Jiao Tong University School of MedicineSmall N (<50) Single country
NCT04922567Efficacy and Safety of Lenalidomide Plus CHOP vs CHOP in Patients With Untreated Peripheral T-Cell LymphomaPHASE2RECRUITINGSecond Affiliated Hospital, School of Medicine, Zhejiang UniversitySurrogate endpoint only Single country
NCT05313243Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed/Refractory T-cell LymphomaPHASE2RECRUITINGYale UniversitySmall N (<50) Surrogate endpoint only Single country
NCT05978141A Registry for People With T-cell LymphomaN/ARECRUITINGMemorial Sloan Kettering Cancer CenterSingle 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).
OptionUA registrationNSZUCost orientationAccess pathway
Standard plan
Romidepsin IV days 1, 8, 15 q28d — r/r PTCL incl AITL (REG-ROMIDEPSIN-PTCL)
1/1 component drug(s) not registered in Ukraine +1
✗ not registered✗ out-of-pocket₴-? — verify pathwaynot recorded
Standard plan
Pralatrexate 30 mg/m² IV weekly × 6 of 7-week cycle (PROPEL schedule) — r/r PTCL (REG-PRALATREXATE-PTCL)
1/2 component drug(s) not registered in Ukraine +1
✗ not registered✗ out-of-pocket₴-? — verify pathwaynot recorded
Trial · NCT05770037
DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage/Young Adult Patients With ALK Positive Cancers
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT07162012
Safety and Efficacy of Anti-EBV Autologous TCR-T Cell Injection in Relapsed/Refractory EBV-Positive Lymphoma
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT06630091
A Phase II, Single-center, Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib in the Management of Newly Diagnosed Peripheral T Cell Lymphoma Patients (GOLDEN Study) and Correlative Study
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT07093710
Golidocitinib Combined With Mitoxantrone Hydrochloride Liposome or Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT04747236
Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT04512534
Sintilimab Combined With Chidamide in Treating Peripheral T Cell Lymphoma
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT07389616
A Clinical Trial of Cidabenamine Plus Azacitidine to Prevent Post-Transplant Progression in High-Risk Peripheral T-Cell Lymphoma
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT04922567
Efficacy and Safety of Lenalidomide Plus CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT05313243
Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed/Refractory T-cell Lymphoma
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT05978141
A Registry for People With T-cell Lymphoma
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: 2026-06-11.