Clinical trial NCT03837873: DLCL002 Protocol for Patients With High Risk Aggressive B-cell Lymphoma
Official title: DLCL002 Protocol for Young Patients With Newly Diagnosed High Risk Aggressive B-cell Lymphoma, a Multicenter Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diffuse Large B Cell Lymphoma
High-grade B-cell Lymphoma
Transformed Lymphoma
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: PFS
timeFrame: 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.
Secondary outcomes:
measure: ORR
timeFrame: up to 3 months after the end of the therapy
measure: EFS
timeFrame: 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.
measure: OS
timeFrame: From the date of the start of treatment until the date of death from any cause, assessed up to 2 years.
measure: CRR
timeFrame: up to 3 months after the end of the therapy
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanchang
country: China
facility: the First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: the First Affiliated Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: the Second Hospital of Dalian Medical University
state: Liaoning
city: Qingdao
country: China
facility: Qingdao Central Hospital
state: Shandong
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
Study officials:
affiliation: Institute of Hematology & Blood Diseases Hospital, China
name: Dehui Zou, Dr.
role: PRINCIPAL_INVESTIGATOR
References: