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Hyper-CVAD/MA for high-risk aggressive B-cell lymphomas: a single-centre academic phase II trial (HYPERION)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505990-34-00
Enrollment
183
Registered
2024-03-08
Start date
2024-11-08
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Brief summary

Event-free survival (EFS) at 3 years, EFS, Progression-free survival (PFS), Overall survival (OS), Lymphoma-specific survival (LSS), Overall response rate (ORR), Complete response rate (CRR), Response rates after 6 cycles, Response rates at final assessment in trial, Response duration

Detailed description

Treatment-related mortality/Non-lymphoma mortality, Time from diagnostic biopsy to start of chemotherapy and to start of steroids., Number and duration of scheduled and unscheduled hospital admissions, Use of IV antibiotics, Total number of hospital days, Time between chemotherapy regimens and total time from starting to ending treatment within trial, Reconstitution of T-cell (cellular and humoral) immunity, Time on sick leave, Long-term cardiac toxicity, Second primary malignancies

Interventions

DRUGDOXORUBICIN HYDROCHLORIDE
DRUGlösning
DRUGVINCRISTINE SULFATE
DRUGVepesid 50 mg mjuka kapslar
DRUGCYCLOPHOSPHAMIDE
DRUGEtoposid Fresenius Kabi 20 mg/ml - koncentrat till infusionsvätska
DRUGMabThera 500 mg concentrate for solution for infusion
DRUGNordimet 15 mg solution for injection in pre-filled pen
DRUGDexametasona Krka 4 mg comprimidos
DRUGCytarabine STADA 100 mg/ml koncentrat till infusionsvätska

Sponsors

Karolinska University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Event-free survival (EFS) at 3 years, EFS, Progression-free survival (PFS), Overall survival (OS), Lymphoma-specific survival (LSS), Overall response rate (ORR), Complete response rate (CRR), Response rates after 6 cycles, Response rates at final assessment in trial, Response duration

Secondary

MeasureTime frame
Treatment-related mortality/Non-lymphoma mortality, Time from diagnostic biopsy to start of chemotherapy and to start of steroids., Number and duration of scheduled and unscheduled hospital admissions, Use of IV antibiotics, Total number of hospital days, Time between chemotherapy regimens and total time from starting to ending treatment within trial, Reconstitution of T-cell (cellular and humoral) immunity, Time on sick leave, Long-term cardiac toxicity, Second primary malignancies

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026