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).
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
118
rituximab 750mg/m2 i.v. on day 0
50mg/m2, continuous i.v. on day 1-4
0.4mg/m2, continuous i.v. on day 1-4
10mg/m2, continuous i.v. on day 1-4
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
750mg/m2, i.v. on day5
25mg/day, p.o. on day 0-9
100mg/m2 continuous i.v. on day 1
2g/m2 q12h, i.v. on day 2
Hunan Cancer Hospital
Changsha, Hunan, China
NOT_YET_RECRUITINGthe First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
NOT_YET_RECRUITINGthe First Affiliated Hospital of Jilin University
Changchun, Jilin, China
NOT_YET_RECRUITINGthe Second Hospital of Dalian Medical University
Dalian, Liaoning, China
NOT_YET_RECRUITINGQingdao Central Hospital
Qingdao, Shandong, China
NOT_YET_RECRUITINGInstitute of Hematology & Blood Diseases Hospital
Tianjin, China
RECRUITINGPFS
progression free survival
Time frame: From the date of the start of treatment until the date of first documented progression, relapse or death from any cause, whichever came first, assessed up to 2 years.
ORR
objective response rate
Time frame: up to 3 months after the end of the therapy
EFS
event free survival
Time frame: From the date of the start of treatment until the date of the first adverse event (i.e. disease progression, relapse, diagnosis of a secondary malignancy, institution of a new anticancer treatment, any cause of death), assessed up to 2 years.
OS
overall survival
Time frame: From the date of the start of treatment until the date of death from any cause, assessed up to 2 years.
CRR
complete response rate
Time frame: up to 3 months after the end of the therapy
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