Trials / Unknown
UnknownNCT03229616
BUCY+VP-16 vs BUCY Conditioning Regimen for DLBCL Undergoing Auto-HSCT
Busulfan+ Cyclophosphamide+ Etoposide vs Busulfan+ Cyclophosphamide Conditioning Regimen for Diffuse Large B-cell Lymphoma Undergoing Autologous Hematopoietic Stem Cell Transplantation
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 122 (estimated)
- Sponsor
- Nanfang Hospital, Southern Medical University · Academic / Other
- Sex
- All
- Age
- 14 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of BUCY+VP-16 and BUCY myeloablative conditioning regimens in diffuse large B-cell lymphoma undergoing autologous hematopoietic stem cell transplantation.
Detailed description
Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective therapy for diffuse large B-cell lymphoma (DLBCL).BuCY conditioning regimen is a conventional scheme for DLBCL patients undergoing auto-HSCT, but it has a high relapse rate. Etoposide (VP-16) is extensively used in chemotherapy regimen for refractory/relapsed lymphoma. Whether addition of VP-16 could reduce the relapse rate remains unclear.In this study, the safety and efficacy of BUCY+VP-16 and BUCY myeloablative conditioning regimens in DLBCL undergoing auto-HSCT are evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Busulfan (BU) | Busulfan was administered at 3.2 mg/kg/day on days -7 to -4. |
| DRUG | Cyclophosphamide (CY) | Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2. |
| DRUG | Etoposide (VP-16) | Etoposide was administered at 15 mg/kg/day on days -3 to -2. |
Timeline
- Start date
- 2017-07-05
- Primary completion
- 2020-06-01
- Completion
- 2020-06-01
- First posted
- 2017-07-25
- Last updated
- 2017-10-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03229616. Inclusion in this directory is not an endorsement.