Clinical trial · Interventional
Rituximab After Autologous Stem Cell Transplant for Relapsed B-cell Non-Hodgkin's Lymphoma
Clinical Trial Of C2B8 Monoclonal Antibody Following High Dose Therapy And Autografting In B-Cell Non-Hodgkin's Lymphoma
- 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)
Conventional therapy is effective for diffuse aggressive lymphomas and low grade lymphomas, but is limited by relapse occurs in 40 to 50% of subjects. This study assesses autologous stem cell transplant (ASCT) supplemented with high-dose therapy increases the event-free survival in diffuse aggressive lymphomas and low grade lymphomas, as an alternative to the limitations of conventional therapy. Preliminary studies with rituximab in low grade lymphomas indicate a response rate of about 50% with very little toxicity. Rituximab is hypothesized to be a candidate for post-transplant therapy because the majority of malignant lymphomas express the CD20 antigen; rituximab has impressive independent anti-tumor activity; and the antibody has little toxicity outside of the acute administration.
Conditions
Conditions (6)
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 Cell Lymphoma | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Other Subtypes of B-cell Lymphoma | — | UNRESOLVED | — |
| Transformed Lymphoma | Transformed Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab 375 mg/m2 | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab after ASCT
- description
- Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT.
- interventionNames
- Drug: Rituximab 375 mg/m2
Primary outcomes (1)
- measure
- Event-free Survival (EFS)
- timeFrame
- 24 months
- description
- "Events" for EFS were defined as the earlier of post-ASCT relapse or death.
Secondary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * B-cell, CD20+ NHL * Evidence of engraftment post-autologous peripheral blood stem cell transplant (PBSC-T), aka autologous stem cell transplant (ASCT) * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 * Creatinine \< 2 mg/dL * Bilirubin \< 2.0 mg/dL * Liver function tests (LFTs) \< 5 x upper limit of normal (ULN) Exclusion Criteria: * Graft source from bone marrow * Non-responders \[progressive disease (PD) or stable disease (SD)\] to prior anti-CD20 therapy * PD after ASCT * Post-ASCT radiotherapy * Concomitant treatment with radiotherapy, chemotherapy or immunotherapy including rituximab * Evidence of active pneumonitis * Evidence of active infection * Concurrent prednisone or other systemic steroid medication * Nitrosourea therapy within 6 weeks of the first treatment with rituximab * Presence of anti-murine antibody (HAMA) reactivity
References
Publications (1)
- RESULTHorwitz SM, Negrin RS, Blume KG, Breslin S, Stuart MJ, Stockerl-Goldstein KE, Johnston LJ, Wong RM, Shizuru JA, Horning SJ. Rituximab as adjuvant to high-dose therapy and autologous hematopoietic cell transplantation for aggressive non-Hodgkin lymphoma. Blood. 2004 Feb 1;103(3):777-83. doi: 10.1182/blood-2003-04-1257. Epub 2003 Aug 7. PMID 12907446