DLCL002 Protocol for Patients With High Risk Aggressive B-cell Lymphoma
NCT ID: NCT03837873
Last Updated: 2022-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
118 participants
INTERVENTIONAL
2019-01-21
2024-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
rituximab 750mg/m2 i.v. on day 0
Etoposide
50mg/m2, continuous i.v. on day 1-4
Vincristine
0.4mg/m2, continuous i.v. on day 1-4
Doxorubicin
10mg/m2, continuous i.v. on day 1-4
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
Cyclophosphamide
750mg/m2, i.v. on day5
Lenalidomide
25mg/day, p.o. on day 0-9
Cisplatin
100mg/m2 continuous i.v. on day 1
Cytarabine
2g/m2 q12h, i.v. on day 2
Interventions
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Rituximab
rituximab 750mg/m2 i.v. on day 0
Etoposide
50mg/m2, continuous i.v. on day 1-4
Vincristine
0.4mg/m2, continuous i.v. on day 1-4
Doxorubicin
10mg/m2, continuous i.v. on day 1-4
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
Cyclophosphamide
750mg/m2, i.v. on day5
Lenalidomide
25mg/day, p.o. on day 0-9
Cisplatin
100mg/m2 continuous i.v. on day 1
Cytarabine
2g/m2 q12h, i.v. on day 2
Eligibility Criteria
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Inclusion Criteria
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
* HIV positivity
18 Years
65 Years
ALL
No
Sponsors
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Institute of Hematology & Blood Diseases Hospital, China
OTHER
Responsible Party
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Zou Dehui
principal investigator
Principal Investigators
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Dehui Zou, Dr.
Role: PRINCIPAL_INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Locations
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Hunan Cancer Hospital
Changsha, Hunan, China
the First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
the First Affiliated Hospital of Jilin University
Changchun, Jilin, China
the Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Qingdao Central Hospital
Qingdao, Shandong, China
Institute of Hematology & Blood Diseases Hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Hui Zhou, Dr.
Role: primary
Fei Li, Dr.
Role: primary
Fengyan Jin, Dr.
Role: primary
Xiaobo Wang, Dr.
Role: primary
Ling Wang, Dr.
Role: primary
Other Identifiers
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IIT2018010-EC-2
Identifier Type: -
Identifier Source: org_study_id
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