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Brief Title: DLCL002 Protocol for Patients With High Risk Aggressive B-cell Lymphoma
Official Title: DLCL002 Protocol for Young Patients With Newly Diagnosed High Risk Aggressive B-cell Lymphoma, a Multicenter Phase II Study
Study ID: NCT03837873
Brief 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).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hunan Cancer Hospital, Changsha, Hunan, China
the First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
the First Affiliated Hospital of Jilin University, Changchun, Jilin, China
the Second Hospital of Dalian Medical University, Dalian, Liaoning, China
Qingdao Central Hospital, Qingdao, Shandong, China
Institute of Hematology & Blood Diseases Hospital, Tianjin, , China
Name: Dehui Zou, Dr.
Affiliation: Institute of Hematology & Blood Diseases Hospital, China
Role: PRINCIPAL_INVESTIGATOR