Overview

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

Status:
Recruiting

Trial end date:
2023-02-01

Target enrollment:
0

Participant gender:
All

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).

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Institute of Hematology & Blood Diseases Hospital

Treatments:

BB 1101
Cisplatin
Cyclophosphamide
Cytarabine
Dexamethasone
Dexamethasone acetate
Doxorubicin
Etoposide
Etoposide phosphate
Lenalidomide
Liposomal doxorubicin
Rituximab
Vincristine

Criteria

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