Clinical trial · Interventional
R-MegaCHOP-ESHAP-BEAM in Patients With High-Risk Aggressive B-Cell Lymphomas
Phase II Study of Intensive Induction (R-MegaCHOP/ESHAP)Followed By Intensive Consolidation (BEAM) In Treatment Of High-Risk Aggressive B-Cell Lymphomas
NCT00558220CI-TRIAL-00000972R-MCEBcompletedPhase 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 purpose of this study is to show if addition of Rituximab to intensive induction (MegaCHOP/ESHAP) and high-dose consolidation (BEAM) improves progression-free and overall survival in patients younger than 65 years with aggressive B-cell lymphoma and aaIPI 2 or 3.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma. | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Follicular Lymphoma Grade III | — | UNRESOLVED | — |
| Primary Mediastinal B-Cell Lymphoma | Primary Mediastinal Large B-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Consolidation treatment part 1: HD-chemotherapy with ASCT | Procedure | — | UNRESOLVED |
| Consolidation treatment part 2: Radiotherapy | Radiation | — | UNRESOLVED |
| immunotherapy | Procedure | — | UNRESOLVED |
| Induction treatment part 1 | Procedure | — | UNRESOLVED |
| Induction treatment part 2 with PBPC collection | Procedure | — | UNRESOLVED |
| Induction treatment part 3 | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- Intensive induction followed by high-dose consolidation with stem cell support ± radiotherapy
- interventionNames
- Procedure: immunotherapy
- Procedure: Induction treatment part 1
- Procedure: Induction treatment part 2 with PBPC collection
- Procedure: Induction treatment part 3
- Procedure: Consolidation treatment part 1: HD-chemotherapy with ASCT
- Radiation: Consolidation treatment part 2: Radiotherapy
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 3 years
Secondary outcomes (2)
- measure
- Complete remission and overall response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Aggressive B-cell lymphoma, namely diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, follicular lymphoma grade III * Age 18-65 years * Age-adjusted IPI score 2-3 * ECOG performance status 0-3 * Signed informed consent Exclusion Criteria: * Burkitt lymphoma * Posttransplant lymphoproliferation * Previous treatment (up to one cycle of standard pretreatment with COP, CHOP or steroids permitted and latter mandatory to decrease tumor burden and/or improve performance status) * Other tumor in previous history with the exception of basalioma, squamous cell carcinoma of the skin or cervical carcinoma in situ * Pregnancy/lactation * CNS involvement * Other serious comorbidities
References
Publications (0)
Data not yet available
No reference posted for this study.