Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, Transformed Lymphoma
Conditions
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).
Interventions
DRUGRituximab
rituximab 750mg/m2 i.v. on day 0
DRUGEtoposide
50mg/m2, continuous i.v. on day 1-4
DRUGVincristine
0.4mg/m2, continuous i.v. on day 1-4
DRUGDoxorubicin
10mg/m2, continuous i.v. on day 1-4
DRUGDexamethasone
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
DRUGCyclophosphamide
750mg/m2, i.v. on day5
DRUGLenalidomide
25mg/day, p.o. on day 0-9
DRUGCisplatin
100mg/m2 continuous i.v. on day 1
DRUGCytarabine
2g/m2 q12h, i.v. on day 2
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 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. | progression free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | up to 3 months after the end of the therapy | objective response rate |
| EFS | 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. | event free survival |
| OS | From the date of the start of treatment until the date of death from any cause, assessed up to 2 years. | overall survival |
| CRR | up to 3 months after the end of the therapy | complete response rate |
Countries
China
Contacts
Primary ContactWei Liu, Dr.
Outcome results
None listed