Clinical trial · Interventional
High-dose Chemotherapy With Rituximab for Adults With Aggressive Large B-cell Lymphoma
Front-line High-dose Chemotherapy (HDT) Combined With Rituximab for Adults With Aggressive Large B-cell Lymphoma (DLBCL) : Goelams 074 Trial.
NCT00965289CI-TRIAL-00002586completedPhase 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)
A prospective pilot trial was proposed to patients with DLBCL, with IH or high adjusted IPI, up to the age of 60 y.o. This program consisted of 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen.
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 |
|---|---|---|---|
| B-Cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HDT combined with rituximab before ASCT
- description
- The study treatment consisted on 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen.
- interventionNames
- Drug: Rituximab
Primary outcomes (1)
- measure
- CR rate after 3 high dose chemotherapy courses
- timeFrame
- safety/efficacy of chemotherapy treatment
Secondary outcomes (3)
- measure
- CR and PR rate at the end of the study treatment
- timeFrame
- safety/efficacy of treatment30 days after the end of post ASCT aplasia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 to 60 y.o * Aggressive Large B-Cell Lymphoma (CD20+) * Ann Arbor stage III, IV * IH or high adjusted IPI * signed inform consent Exclusion Criteria: * Age \< 18 ou \> 60 y.o * other type of lymphoma * serology VIH + * other neoplasms apart from basal cell carcinoma or situ carcinoma
References
Publications (0)
Data not yet available
No reference posted for this study.