Clinical trial · Interventional
Rituximab and DexaBEAM as Salvage Therapy for Relapsed Lymphoma
Eine Phase II Studie Zur Beurteilung Der Wirksamkeit Von Rituximab in Der Salvage- Und Hochdosistherapie Mit Autologer Stammzelltransplantation Bei Patienten Mit B-Zell-Non-Hodgkin-Lymphom
NCT02099292CI-TRIAL-00014127Mz-135completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 investigator prospectively evaluated the combination of Rituximab and Dexa-BEAM (dexamethasone, carmustine, etoposide, cytarabine, melphalan) followed by high dose therapy in patients with relapsed/refractory aggressive and indolent lymphoma.
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 |
|---|---|---|---|
| Relapsed Non-Hodgkin-Lymphoma | Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab and DexaBEAM | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab and DexaBEAM
- description
- Rituximab and DexaBEAM
- interventionNames
- Drug: Rituximab and DexaBEAM
Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- five years follow up
- description
- PFS at 5 years in patients * completing the entire protocol (PPP) * intention to treat population (IIT)
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
- five years follow up
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * age between 18 and 65 years * Patients with aggressive B-cell-lymphoma:diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) or grade IIIB follicular lymphoma (FL) with relapse after complete remission (CR) or failure to achieve CR on treatment. * Patients with indolent lymphoma: FL grade I-IIIA, marginal zone lymphoma (MZL) and immunocytoma (IC) if relapsed or failure to achieve at least partial remission (PR) on treatment. * CD20 positive * previous therapy: at least 3 cycles of anthracycline containing regimens. * ECOG (Eastern Cooperative Oncology Group) 0-2 * measurable disease * adequate bone marrow function (absolute neutrophil count \[ANC\] \>1500/µl; platelet count \>100,000/µl), unless there was clear evidence of bone marrow involvement * glomerular filtration rate \> 60ml/min * ASAT(aspartate transaminase)/ALAT(alanine aminotransferase) \< 2.5-fold upper limit of normal (ULN) unless associated with liver infiltration * free from other cancers for at least 5 years, with the exception of basal cell carcinoma and carcinoma in situ of the uterine cervix. * given informed consent Exclusion Criteria: * (central nervous system) CNS-lymphoma * HIV * Hepatitis B or C * pregnancy * breast-feeding women * high dose therapy or allogeneic transplantation * glomerular filtration rate \< 60ml/min * ASAT/ALAT \> 2.5-fold upper limit of normal (ULN) unless associated with liver infiltration
References
Publications (0)
Data not yet available
No reference posted for this study.