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

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).

Inclusion Criteria:

• Histological confirmed aggressive B-cell lymphoma with one of the following subtypes:

  1. diffuse large B-cell lymphoma, NOS with at least one poor prognostic factor as follows:

     1. aaIPI 2~3(≤60 years) or IPI 3~5(>60 years);
     2. double protein expression lymphoma(IHC MYC≥40% and BCL2≥50%） with Ann Arbor stage of III~IV or aaIPI 2~3 or IPI 3~5;
     3. CD5+ DLBCL.

  2. high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements;

  3. high-grade B-cell lymphoma, NOS

  4. transformed lymphoma(no prior treatment)

• Age 18 to 65 years

• ECOG-PS: 0~2

• Life-expectancy > 3 months

Exclusion Criteria:

• Patients with central nerves system involvement
• HIV positivity