NCT03018626

R-ACVBP and DA-EPOCH-R in Patients With Non-GCB DLBCL

Study of R-ACVBP and DA-EPOCH-R in Patients With Newly Diagnosed Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 402 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, multi-center, phase 3 study evaluating the efficacy of R-ACVBP and DA-EPOCH-R in patients with newly diagnosed non-germinal b-cell-like diffuse large B-cell lymphoma

Detailed description

Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma. According to Hans' algorithms, DLBCL can be identified as 2 subtypes: germinal b-cell-like(GCB) and non-germinal b-cell-like(non-GCB). Approximately 50 to 60% of diffuse large-B cell lymphoma(DLBCL) was non-GCB subtype DLBCL. Although the introduction of rituximab in immunochemotherapy has dramatically improved the outcome of patients with DLBCL, The survival was still poor in non-GCB DLBCL patients treated with R-CHOP. The LNH03-2B study has shown that R-ACVBP regimen gave a longer PFS (93% vs. 74% at 3 years, p=0.0074) and a longer OS (97% vs. 83% at 3 years, p=0.0067) than R-CHOP in young patients with non-GCB DLBCL. It also showed that R-ACVBP regimen gave a longer PFS (87% vs. 73% at 3 years, p=0.0074) and a longer OS (92% vs. 84% at 3 years, p=0.0067) than R-CHOP in young low-intermediate risk DLBCL patients. The LNH2003-3 study has shown that in high-risk (2/3 IPI factors) DLBCL patients treated with R-ACVBP followed by auto-ASCT results in a 74% PFS and 76% OS. Hematological toxic effects of the intensive regimen were raised but manageable. The CALGB study showed that in DLBCL patients at least 18 years of age and at least stage II, DA-EPOCH-R regimen is effective in both GCB and non-GCB subtypes, with a 5-years TTP 67%, EFS 58% and OS 68% in non-GCB subtype DLBCL. It is encouraging that PETHEMA Group study showed that in the long-term follow-up of untreated DLBCL patients with poor prognosis, DA-EPOCH-R achieved a 70.8% EFS and 76.4% OS at 10 years in non-GCB subtype DLBCL. However the efficacy of R-ACVBP compared to DA-EPOCH-R in patients with newly diagnosed non-germinal b-cell-like diffuse large B-cell lymphoma remains unknown. All the above-mentioned results led us to propose a randomized trial comparing R-ACVBP to DA-EPOCH-R in previously untreated patients with non-GCB DLBCL.

Conditions

• Lymphoma, Large B-Cell, Diffuse

Interventions

Type	Name	Description
DRUG	Rituximab	rituximab (375 mg/m2) given intravenously (IV) on day 0
DRUG	Etoposide	Etoposide(50 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours)
DRUG	Doxorubicin	Doxorubicin(10 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours)
DRUG	Vincristine	Vincristine(0.4 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours)
DRUG	Cyclophosphamide	Cyclophosphamide(750 mg/m2)/dayg IV on days 5
DRUG	Prednisone	prednisone (100 mg) given orally bid on days 1 through to 5.
DRUG	Doxorubicin	Doxorubicin (75 mg/m2) given intravenously (IV) on day 1,
DRUG	Cyclophosphamide	Cyclophosphamide (1,200 mg/m2) given intravenously (IV) on day 1,
DRUG	Vindesine	Vindesine (2 mg/m2) given on days 1 and 5
DRUG	Bleomycin	Bleomycin (10 mg) given IV on days 1 and 5

Timeline

• Start date: 2017-07-27
• Primary completion: 2020-01-01
• Completion: 2021-01-01
• First posted: 2017-01-12
• Last updated: 2017-07-28

Locations

1 site across 1 country: China