Clinical trial · Interventional
Rituximab and Gemcitabine for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Phase II Study of Rituximab and Gemcitabine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: Hoosier Oncology Group LYM03-64
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated due to lack of response at the first efficacy analysis
Summary
Brief summary (as posted)
Rituximab has been demonstrated to sensitize drug-resistant NHL cells to the cytotoxic actions of several chemotherapy agents by enhancing sensitivity of tumor cells to chemotherapy-induced apoptosis. Gemcitabine, a nucleoside analog that is used in several other malignancies, has shown very promising activity in patients with refractory Hodgkin's disease and low-grade NHL. The combination of rituximab and gemcitabine may have synergistic cytotoxic action in patients with relapsed or refractory DLBCL and possibly lead to improved response rates and demonstrable clinical benefit. This trial will investigate the efficacy the combination of rituximab and gemcitabine in treating patients with relapsed or refractory DLBCL.
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, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Rituximab + Gemcitabine for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- interventionNames
- Drug: Rituximab
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- · Evaluate response rates to the rituximab plus gemcitabine treatment combination in patients with relapsed or refractory DLBCL.
- timeFrame
- 18 months
Secondary outcomes (1)
- measure
- · Evaluate toxicity, time to progression and overall survival.
- timeFrame
- 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy-proven DLBCL which meet the criteria of any of the 4 subgroups * Transformed DLBCL from a previous indolent NHL which meet the criteria of any of the 4 subgroups and have received at least one standard chemotherapy regimen for aggressive NHL or a biopsy upon progression of disease has been obtained to confirm the presence of DLBCL. The concomitant presence of a component of low grade lymphoma will NOT exclude participation * Measurable disease per Standardized Response Criteria for Non-Hodgkin's Lymphoma * Prior gemcitabine therapy is allowed. * Negative pregnancy test Exclusion Criteria: * No history of life-threatening reactions to rituximab. * No history of gemcitabine intolerance; prior gemcitabine therapy is allowed. * No history of malignancy in the last 5 years (basal cell carcinoma of the skin excluded). * No central nervous system or cerebrospinal fluid involvement * No other investigational drugs received within 30 days prior to being registered for protocol therapy. * No active infections. * No current breastfeeding
References
Publications (0)
Data not yet available