Clinical trial · Interventional
Study of Rituximab Plus High-Dose Chemotherapy Poor Prognosis Non-Hodgkin's Lymphoma
Rituximab Plus High-Dose Chemotherapy With Autologous Stem Cell Support for Poor-Prognosis Non-Hodgkin's Lymphoma
NCT00141700CI-TRIAL-00001096terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): enrollment completed
Summary
Brief summary (as posted)
This study is being conducted to determine the safety, side effects, and response to a combination of an established high-dose chemotherapy regimen, stem cell support and Rituximab (which is a form of immunotherapy).
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, Non-Hodgkin's | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Assess progression-free survival after rituximab and high-dose chemotherapy with autologous PBPC support;
Secondary outcomes (3)
- measure
- Assess overall survival (OS) after rituximab and high-dose chemotherapy with PBPC support.
- measure
- Assess safety and toxicity after rituximab and high-dose chemotherapy.
- measure
- Assess CD20 recovery post-transplant
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Histologically documented, aggressive and/or intermediate grade and high-grade B cell NHL, CD20 positive. * Histologic subtypes include follicular large cell, diffuse small cleaved cell, diffuse mixed small and large cell, diffuse large cell, anaplastic large cell, and mantle cell lymphomas. * NHL must have high-intermediate or high International Prognostic Index (standard IPI) score at diagnosis. Mantle cell NHL is eligible regardless of IPI score. * Complete or partial response to first-line therapy. * Treated CNS or meningeal disease, using radiation therapy and/or intrathecal chemotherapy, is allowed. Patients with meningeal disease must have cytologically negative CSF at time of study entry. * Cumulative total doxorubicin: \<500 mg/m2 * Performance score 0-2 * Patients with a prior malignancy are eligible if they were treated with curative intent and have no evidence of active disease. * Patients must not be pregnant or nursing. * Informed Consent Exclusion Criteria: * pregnant or nursing
References
Publications (0)
Data not yet available
No reference posted for this study.