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

Institute of Hematology & Blood Diseases Hospital, China

Status and phase

Enrolling

Phase 2

Conditions

High-grade B-cell Lymphoma

Diffuse Large B Cell Lymphoma

Transformed Lymphoma

Treatments

Drug: Doxorubicin

Drug: Rituximab

Drug: Cisplatin

Drug: Vincristine

Drug: Dexamethasone

Drug: Lenalidomide

Drug: Etoposide

Drug: Cytarabine

Drug: Cyclophosphamide

Study type

Interventional

Funder types

Other

Identifiers

NCT03837873

IIT2018010-EC-2

Details and patient eligibility

About

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).

Full 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).

Enrollment

118 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

118 participants in 1 patient group

DLCL002 protocol

Experimental group

Description:

Patients will receive R-DA-EDOCH(rituximab, etoposide, dexamethasone, vincristine, cyclophosphamide, doxorubicin) as induction therapy and be evaluated by PET CT after the fourth cycle. Patients achieve CR at interim-PET 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(rituximab, lenalidomide(only for patients with non-GCB DLBCL), dexamethasone, cisplatin, cytarabine). 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.

Treatment: