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

Primary Purpose

Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, Transformed Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Rituximab
Etoposide
Vincristine
Doxorubicin
Dexamethasone
Cyclophosphamide
Lenalidomide
Cisplatin
Cytarabine
Sponsored by
Institute of Hematology & Blood Diseases Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hunan Cancer Hospital
  • the First Affiliated Hospital of Nanchang University
  • the First Affiliated Hospital of Jilin University
  • the Second Hospital of Dalian Medical University
  • Qingdao Central Hospital
  • Institute of Hematology & Blood Diseases HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DLCL002 protocol

Arm 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.

Outcomes

Primary Outcome Measures

PFS
progression free survival

Secondary Outcome Measures

ORR
objective response rate
EFS
event free survival
OS
overall survival
CRR
complete response rate

Full Information

First Posted
January 5, 2019
Last Updated
January 24, 2022
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT03837873
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2019 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Hematology & Blood Diseases Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, Transformed Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DLCL002 protocol
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
rituximab 750mg/m2 i.v. on day 0
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
50mg/m2, continuous i.v. on day 1-4
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
0.4mg/m2, continuous i.v. on day 1-4
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
10mg/m2, continuous i.v. on day 1-4
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
750mg/m2, i.v. on day5
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
25mg/day, p.o. on day 0-9
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
100mg/m2 continuous i.v. on day 1
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Description
2g/m2 q12h, i.v. on day 2
Primary Outcome Measure Information:
Title
PFS
Description
progression free survival
Time Frame
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 Outcome Measure Information:
Title
ORR
Description
objective response rate
Time Frame
up to 3 months after the end of the therapy
Title
EFS
Description
event free survival
Time Frame
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.
Title
OS
Description
overall survival
Time Frame
From the date of the start of treatment until the date of death from any cause, assessed up to 2 years.
Title
CRR
Description
complete response rate
Time Frame
up to 3 months after the end of the therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: Patients with central nerves system involvement HIV positivity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Liu, Dr.
Phone
+86-020-23909282
Email
liuwei@ihcams.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dehui Zou, Dr.
Organizational Affiliation
Institute of Hematology & Blood Diseases Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Zhou, Dr.
First Name & Middle Initial & Last Name & Degree
Hui Zhou, Dr.
Facility Name
the First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Li, Dr.
First Name & Middle Initial & Last Name & Degree
Fei Li, Dr.
Facility Name
the First Affiliated Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengyan Jin, Dr.
First Name & Middle Initial & Last Name & Degree
Fengyan Jin, Dr.
Facility Name
the Second Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaobo Wang, Dr.
First Name & Middle Initial & Last Name & Degree
Xiaobo Wang, Dr.
Facility Name
Qingdao Central Hospital
City
Qingdao
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling Wang, Dr.
First Name & Middle Initial & Last Name & Degree
Ling Wang, Dr.
Facility Name
Institute of Hematology & Blood Diseases Hospital
City
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Liu, Dr.
Phone
86-022-23909282
Email
liuwei@ihcams.ac.cn
First Name & Middle Initial & Last Name & Degree
Dehui Zou, Dr.
First Name & Middle Initial & Last Name & Degree
Wei Liu, Dr.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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