Status:
UNKNOWN
DLCL002 Protocol for Patients With High Risk Aggressive B-cell Lymphoma
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Diffuse Large B Cell Lymphoma
High-grade B-cell Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- Histological confirmed aggressive B-cell lymphoma with one of the following subtypes:
- diffuse large B-cell lymphoma, NOS with at least one poor prognostic factor as follows:
- aaIPI 2\~3(≤60 years) or IPI 3\~5(\>60 years);
- 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;
- CD5+ DLBCL.
- high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements;
- high-grade B-cell lymphoma, NOS
- transformed lymphoma(no prior treatment)
- Age 18 to 65 years
- ECOG-PS: 0\~2
- Life-expectancy \> 3 months
Exclusion
- Patients with central nerves system involvement
- HIV positivity
Key Trial Info
Start Date :
January 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT03837873
Start Date
January 21 2019
End Date
September 1 2024
Last Update
January 26 2022
Active Locations (6)
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1
Hunan Cancer Hospital
Changsha, Hunan, China
2
the First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
3
the First Affiliated Hospital of Jilin University
Changchun, Jilin, China
4
the Second Hospital of Dalian Medical University
Dalian, Liaoning, China