NCT03837873

DLCL002 Protocol for Patients With High Risk Aggressive B-cell Lymphoma

DLCL002 Protocol for Young Patients With Newly Diagnosed High Risk Aggressive B-cell Lymphoma, a Multicenter Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Patients eligible for the study will receive R-DA-EDOCH as the induction therapy and be evaluated by PET CT after the fourth cycle. Patients achieve CR at interim-PET(Deauville score 1-3) will receive either ASCT or the remaining 4 cycles of R-DA-EDOCH, while those achieve PR(Deauville score 4-5) will be rescued by two courses of R(2)-DHAP and then be revaluated by the second interim-PET. Patients who achieved CR+good PR(Deauville score 4) after the rescue therapy will be consolidated with ASCT,and those remain in PR(Deauville score 5) will receive other rescue treatments(including ASCT+CAR T).

Detailed description

Survival for patients with high risk aggressive B-cell lymphoma is still unsatisfied. Dose-intensified immunochemotherapy might improve the outcome. But for patients who could not achieve CR after the dose-intensified induction therapy, the prognosis is poor. The DLCL002 protocol is a total therapy which including induction therapy, rescue therapy and autologous stem cell transplantation. Patients eligible for the study will receive R-DA-EDOCH as the induction therapy and be evaluated by PET CT after the fourth cycle. Patients achieve CR at interim-PET(Deauville score 1-3) will receive either ASCT or the remaining 4 cycles of R-DA-EDOCH, while those achieve PR(Deauville score 4-5) will be rescued by two courses of R(2)-DHAP and then be revaluated by the second interim-PET. Patients who achieved CR+good PR(Deauville score 4) after the rescue therapy will be consolidated with ASCT,and those remain in PR(Deauville score 5) will receive other rescue treatments(including ASCT+CAR T).

Conditions

• Diffuse Large B Cell Lymphoma
• High-grade B-cell Lymphoma
• Transformed Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	rituximab 750mg/m2 i.v. on day 0
DRUG	Etoposide	50mg/m2, continuous i.v. on day 1-4
DRUG	Vincristine	0.4mg/m2, continuous i.v. on day 1-4
DRUG	Doxorubicin	10mg/m2, continuous i.v. on day 1-4
DRUG	Dexamethasone	30mg/day, i.v. on day 1-5 for R-DA-EDOCH regimen; 40mg/day, i.v. on day 1-4 for R(2)-DHAP regimen
DRUG	Cyclophosphamide	750mg/m2, i.v. on day5
DRUG	Lenalidomide	25mg/day, p.o. on day 0-9
DRUG	Cisplatin	100mg/m2 continuous i.v. on day 1
DRUG	Cytarabine	2g/m2 q12h, i.v. on day 2

Timeline

• Start date: 2019-01-21
• Primary completion: 2023-09-01
• Completion: 2024-09-01
• First posted: 2019-02-12
• Last updated: 2022-01-26

Locations

6 sites across 1 country: China