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

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03837873
• Other study ID #: IIT2018010-EC-2
• Status: Recruiting
• Phase: Phase 2
• Start date: January 21, 2019
• Est. completion date: September 1, 2024

Study information

• Verified date: January 2022
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: Wei Liu, Dr.
• Phone: +86-020-23909282
• Email: liuwei[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Jilin University	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	the Second Hospital of Dalian Medical University	Dalian	Liaoning
China	the First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Qingdao Central Hospital	Qingdao	Shandong
China	Institute of Hematology & Blood Diseases Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	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	ORR	objective response rate	up to 3 months after the end of the therapy
Secondary	EFS	event free survival	From the date of the start of treatment until the date of the ?rst 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.
Secondary	OS	overall survival	From the date of the start of treatment until the date of death from any cause, assessed up to 2 years.
Secondary	CRR	complete response rate	up to 3 months after the end of the therapy