Clinical trial · Interventional
Rituximab Maintenance After Autologous Transplantation
Maintenance Therapy With Rituximab After Autologous Transplantation for Non-Hodgkin's Lymphoma
NCT01103388CI-TRIAL-00007601terminatedPhase 3ClinicalTrials.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): Closed early due to slow patient accrual and sponsor's withdrawal of support.
Summary
Brief summary (as posted)
The goal of this clinical research is to see if Rituxan (rituximab) therapy given after high dose chemotherapy and transplant of a patients own stem cells will prevent or delay the return of the 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 |
|---|---|---|---|
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rituximab
- interventionNames
- Drug: Rituximab
- type
- NO_INTERVENTION
- label
- No Rituximbab
Primary outcomes (1)
- measure
- Number of Patients with Progression Free Survival (PFS)
- timeFrame
- 2 Years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Patients with diffuse large B cell non-Hodgkin's lymphoma who are 5-6 months status post an autologous stem cell transplant and are in CR. Patients who are positive for t(14;18) by PCR or for BCL-2 by Southern blot are eligible provided there is no other disease present. 2. Absolute neutrophil count (ANC) \> 1500/mm3 independent of growth factor support 3. No evidence of symptomatic cardiac or pulmonary disease 4. Platelet count \> 75,000 mm3 5. Zubrod performance status of 2 or less. 6. Negative pregnancy test in patients of "child bearing potential" Exclusion Criteria: 1. Uncontrolled active infection 2. Severe concomitant medical or psychiatric illness 3. Serum bilirubin \> 2.0 mg/dl 4) Transaminases \> 2xULN 5) Serum creatinine \> 2.0 mg/dl
References
Publications (0)
Data not yet available
No reference posted for this study.