Clinical trial · Interventional
ACVBP Followed by ASCT in Patients With BCL-2 Positive Diffuse Large B-Cell Lymphoma
Prospective Study of ACVBP Followed by Autologous Stem Cell Transplantation in Case of BCL-2 Overexpression in Non Previously Treated Patients Aged 60 Years or Less With Low-Intermediate Risk Diffuse Large B-Cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of the study is to evaluate the efficacy of ASCT as consolidation in case of bcl-2 overexpression in non previously treated patients aged 60 years or less with low-intermediate risk diffuse large B-cell lymphoma who responded to ACVBP regimen. Our goal is to obtain a 15% increase of event-free survival at 2 years.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Large-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous stem cell transplantation | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Event free survival.
Secondary outcomes (3)
- measure
- Complete response rate at the end of treatment.
- measure
- Disease-free survival for complete responders.
- measure
- Overall survival.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Patient with diffuse large B-cell lymphoma according to the WHO classification (anti CD20 labeling) * Aged 18 to 60 years * Non previously treated * With one and only one of the following adverse characteristics: ECOG performance status 2 or more, or Ann Arbor stage III or IV, or elevated LDH level * Negative HIV, HBV and HCV serologies (except vaccination) * With a minimum life expectancy of 3 months * Having previously signed a written informed consent Exclusion Criteria: * Any history of treated or non-treated indolent lymphoma. * T-cell lymphoma. * Central nervous system or meningeal involvement by lymphoma. * Any Contra-indication to any drug contained in the chemotherapy regimens. * Poor renal function (creatinin level\>150µmol/l), poor hepatic function (total bilirubin level\>30mmol/l, transaminases\>2.5 maximum normal level) unless these abnormalities are related to the lymphoma. * Serious active disease (according to the investigator's decision). * Poor bone marrow reserve as defined by neutrophils \<1.5G/l or platelets\<100G/l, unless related to bone marrow infiltration. * Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. * Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study. * Childbearing woman. * Patients previously treated with an organ transplantation.
References
Publications (0)
Data not yet available