Clinical trial · Interventional
Study of Rituximab Plus High-Dose Chemotherapy Non-Hodgkin's Lymphoma
Rituximab Plus High-dose Chemotherapy With Autologous Stem Cell Support for Non-Hodgkin's Lymphoma
NCT00143871CI-TRIAL-00006160completedPhase 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)
This study is being conducted to determine the safety, side effects, and response to a combination of an established high-dose chemotherapy regimen, plus the addition of 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 safety and toxicity after rituximab and high-dose chemotherapy
Secondary outcomes (3)
- measure
- Assess CD20 depletion in leukapheresis products after rituximab and high-dose chemotherapy, and monitor CD20 recovery post-transplant
- measure
- Assess the response rate after rituximab and high-dose chemotherapy with autologous peripheral blood progenitor cell (PBPC) support, for patients with relapsed CD20+ Non-Hodgkin's lymphoma (NHL)
- measure
- Assess progression-free and overall survival after rituximab and high-dose chemotherapy with PBPC support
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. * In relapse after primary conventional chemotherapy * Tumor sensitive (at least a partial response) to induction chemotherapy and/ or radiation therapy after treatment for relapse * Treatment of CNS or meningeal disease (cytology-negative CSF) if present * Treatment of CNS or meningeal disease (cytology-negative CSF) if present. * Cumulative total doxorubicin dosage \<500 mg/m2 * Performance score: 0-2 * Prior malignancies eligible if treated for cure and without active disease * Patients must not be pregnant or nursing. * Prior Immunotherapy is allowed * Signed Informed Consent * Absolute neutrophil count \> 1500/ µl, platelet count \>100,000/ µl * Bilirubin \<1.5 x normal, SGOT \<2.5 x normal * Serum creatinine \<1.5 mg/dl * Ejection fraction \> 45% or \> 40% with normal wall motion * HIV negative * FEV1, DLCO \> 50% predicted Exclusion Criteria: * Pregnant or nursing
References
Publications (0)
Data not yet available
No reference posted for this study.