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

January 24, 2022 updated by: Zou Dehui, Institute of Hematology & Blood Diseases Hospital

DLCL002 Protocol for Young Patients With Newly Diagnosed High Risk Aggressive B-cell Lymphoma, a Multicenter Phase II Study

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

118

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Tianjin, China, 300020
        • Recruiting
        • Institute of Hematology & Blood Diseases Hospital
        • Contact:
        • Sub-Investigator:
          • Wei Liu, Dr.
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Hui Zhou, Dr.
        • Principal Investigator:
          • Hui Zhou, Dr.
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Not yet recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Fei Li, Dr.
        • Principal Investigator:
          • Fei Li, Dr.
    • Jilin
      • Changchun, Jilin, China
        • Not yet recruiting
        • The first Affiliated Hospital of Jilin University
        • Contact:
          • Fengyan Jin, Dr.
        • Principal Investigator:
          • Fengyan Jin, Dr.
    • Liaoning
      • Dalian, Liaoning, China
        • Not yet recruiting
        • The Second Hospital of DALIAN Medical University
        • Contact:
          • Xiaobo Wang, Dr.
        • Principal Investigator:
          • Xiaobo Wang, Dr.
    • Shandong
      • Qingdao, Shandong, China
        • Not yet recruiting
        • Qingdao Central Hospital
        • Contact:
          • Ling Wang, Dr.
        • Principal Investigator:
          • Ling Wang, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DLCL002 protocol
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.
Drug: Rituximab
rituximab 750mg/m2 i.v. on day 0
Drug: Etoposide
50mg/m2, continuous i.v. on day 1-4
Drug: Vincristine
0.4mg/m2, continuous i.v. on day 1-4
Drug: Doxorubicin
10mg/m2, continuous i.v. on day 1-4
Drug: Dexamethasone
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
Drug: Cyclophosphamide
750mg/m2, i.v. on day5
Drug: Lenalidomide
25mg/day, p.o. on day 0-9
Drug: Cisplatin
100mg/m2 continuous i.v. on day 1
Drug: Cytarabine
2g/m2 q12h, i.v. on day 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
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.
progression free survival
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 Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: up to 3 months after the end of the therapy
objective response rate
up to 3 months after the end of the therapy
EFS
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.
event free survival
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.
OS
Time Frame: From the date of the start of treatment until the date of death from any cause, assessed up to 2 years.
overall survival
From the date of the start of treatment until the date of death from any cause, assessed up to 2 years.
CRR
Time Frame: up to 3 months after the end of the therapy
complete response rate
up to 3 months after the end of the therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Hematology & Blood Diseases Hospital

Investigators

  • Principal Investigator: Dehui Zou, Dr., Institute of Hematology & Blood Diseases Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2019

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

January 5, 2019

First Submitted That Met QC Criteria

February 11, 2019

First Posted (Actual)

February 12, 2019

Study Record Updates

Last Update Posted (Actual)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 24, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2018010-EC-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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