- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03837873
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
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
- Name: Wei Liu, Dr.
- Phone Number: +86-020-23909282
- Email: liuwei@ihcams.ac.cn
Study Locations
-
-
-
Tianjin, China, 300020
- Recruiting
- Institute of Hematology & Blood Diseases Hospital
-
Contact:
- Wei Liu, Dr.
- Phone Number: 86-022-23909282
- Email: liuwei@ihcams.ac.cn
-
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:
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
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.
|
rituximab 750mg/m2 i.v. on day 0
50mg/m2, continuous i.v. on day 1-4
0.4mg/m2, continuous i.v. on day 1-4
10mg/m2, continuous i.v. on day 1-4
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
750mg/m2, i.v. on day5
25mg/day, p.o. on day 0-9
100mg/m2 continuous i.v. on day 1
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.
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
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Antibiotics, Antineoplastic
- Dexamethasone
- Cyclophosphamide
- Etoposide
- Cisplatin
- Lenalidomide
- Rituximab
- Doxorubicin
- Cytarabine
- Vincristine
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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