Clinical trial · Interventional
GVD±R Regimen for ASCT-eligible Patients With Refractory/Relapsed DLBCL
GVD±R (Gemcitabine, Oral Vinorelbine and Doxorubicin Liposome, With or Without Rituximab) Regimen for Autologous Hematopoietic Stem Cell Transplantation(ASCT)-Eligible Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma:a Multi-center, Single Arm, Phase II Study
- 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)
The purpose of this multi-center,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of GVD±R (gemcitabine, oral vinorelbine and doxorubicin liposome, with or without rituximab) regimen for autologous hematopoietic stem cell transplantation(ASCT)-eligible patients with refractory/relapsed diffuse large B-cell 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 |
|---|---|---|---|
| Lymphoma, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GVD with or without R
- description
- Gemcitabine 1000mg/m2, d1,d8, intravenous drip; Vinorelbine 50mg/m2, d1,d8, oral; Doxorubicin liposomes 30mg/m2, d1,intravenous drip; With or without rituximab 375 mg/m2, d0,intravenous drip; All patients received up to 6 treatment cycles of 21 days.
- interventionNames
- Drug: gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab
Primary outcomes (1)
- measure
- ORR
- timeFrame
- 4-years
Secondary outcomes (4)
- measure
- success rates in autologous stem cell mobilization
- timeFrame
- 4-years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * biopsy proved CD20+ DLBCL; * previously received at least one systemic treatment (including chemotherapy) without remission or relapse after remission; * at least one evaluable lesion； * ECOG PS 0-1; * 18-65 years; * proper functioning of the major organs. Exclusion Criteria: * involvement of central nervous system; * with other malignancy; * patients receiving or received drug of other clinical trial within 30 days； * previously received doxorubicin liposome or have used other anthracycline drug with accumulated restricted doses (adriamycin 450mg/m2, epirubicin 935mg/m2, acrarubicin 900mg/m2)； * patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment; * grade 2 or more peripheral neuropathy.
References
Publications (0)
Data not yet available