Back to resultsR2 and Combination Chemotherapy Versus R and Combination Chemotherapy in Newly Diagnosed Highly Aggressive B-NHL
Primary Purpose
Lymphoma, B-Cell
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
R2-combination chemotherapy
R-combination chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, B-Cell focused on measuring Lenalidomide，rituximab，chemotherapy，highly aggressive B-NHL
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed highly aggressively B-Cell Non-Hodgkin's lymphoma (NHL) confirmed by histopathology
- The patient has at least ≥1 measurable tumor lesion with a diameter >1.5 cm;
- The patient has not undergone systemic chemotherapy or immunotherapy before;
- ECOG score ≤ 2 points;
- Liver and kidney function meets the following conditions: creatinine clearance rate ≥ 30ml / min, total bilirubin, AST and ALT ≤ 2.5 × ULN;
- No history of malignant tumors within 5 years, except for cured carcinomas in situ such as basal cell carcinoma of the skin, cervical cancer, breast cancer, prostate cancer, etc.;
- agree to take contraceptive measures during the trial period and within 3 months after the end of the trial;
- Patients volunteered to participate in the study and signed informed consent.
Exclusion Criteria:
- Serious cardiovascular and other important organs and blood, endocrine system lesions, and other history of malignant tumors;
- Severe mental illness;
- Pregnant or lactating women and men or women who intend to conceive in the near future;
- The expected survival time is less than 6 months;
- HBV, HCV or HIV infection or seropositive;
- there are active infections;
- Allergies or allergies to rituximab;
- Compliance or poor follow-up;
- Other circumstances that the investigator believes are not suitable for inclusion.
Sites / Locations
- Department of Hematology, Provincial Hospital Affiliated to Shandong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
R2-combination chemotherapy
R-combination chemotherapy
Arm Description
R2-CHOP/CHOPE/DA-EPOCH/HD MTX R2-CHOP : lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0 Cyclophosphamide 750mg / m2 d1, doxorubicin 70mg / m2 or Doxorubicin liposome 30-40 mg / m2 d2, vincristine 1.4mg / m2 or vindesine 3mg / m2 d2, prednisone 100mg d1-5 R2-DA-EPOCH: lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0 Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5; R2-HD MTX: lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0； MTX 3.5g／ｍ２,ｄ1
R-CHOP/CHOPE/DA-EPOCH/HD MTX R-CHOP : Rituximab：375mg/m2，ivgtt，D0 Cyclophosphamide 750mg / m2 d1, doxorubicin 70mg / m2 or Doxorubicin liposome 30-40 mg / m2 d2, vincristine 1.4mg / m2 or vindesine 3mg / m2 d2, prednisone 100mg d1-5 R-DA-EPOCH: Rituximab：375mg/m2，ivgtt，D0 Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5; R-HD MTX: Rituximab：375mg/m2，ivgtt，D0； MTX 3.5g／ｍ２,ｄ1
Outcomes
Primary Outcome Measures
Overall Response Rate after 3 cycles
Percentage of patients with complete remission （CR）or partial remission （PR）
Overall Response Rate after 6 cycles
Percentage of patients with complete remission （CR）or partial remission （PR）
Secondary Outcome Measures
Progression free survival（PFS）
Time from enrollment to tumor progression or death
overall survival（OS）
Time from enrollment to death
Full Information
NCT ID
NCT04152577
First Posted
October 27, 2019
Last Updated
November 4, 2019
Sponsor
Shandong Provincial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04152577
Brief Title
R2 and Combination Chemotherapy Versus R and Combination Chemotherapy in Newly Diagnosed Highly Aggressive B-NHL
Official Title
Lenalidomide, Rituximab and Combination Chemotherapy Versus Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Highly Aggressive Non-Hodgkin B-cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 5, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong Provincial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
In this study，lenalidomide was added in the first-line treatment in the newly diagnosed highly invasively non-Hodgkin B-cell lymphoma. The R2-CHOP/R2-EPOCH etc was applied compared with the classical R-CHOP/R-EPOCH etc. The investigators tried to explore a more effective and safe treatment regimen for patients with high-risk B-cell lymphoma to improve the patient's poor prognosis.
Detailed Description
Lymphoma has become one of the top ten malignant tumors, of which non-Hodgkin's B-cell lymphoma accounts for the majority. As the classic first-line treatment, the emergence of the R-CHOP program has resulted in clinical cures for more than 1/2 of patients with B-cell lymphoma. But for patients with highly aggressively B cell lymphoma, most of them still suffer from disease recurrences due to R-CHOP treatment alone.
In recent years, with the emergence of various new drugs, many researchers have tried to add new drugs to the classic R-CHOP program as a first-line treatment for non-Hodgkin B-cell lymphoma. As a new type of immunomodulator, lenalidomide was first approved for the treatment of multiple myeloma. In recent years, its role in refractory and relapsed B-cell lymphoma has gradually been recognized.
In 2015, Nowakowski et al. published a clinical study of 64 patients with diffuse large B-cell lymphoma who used R2-CHOP in first-line therapy. It was found that R2-CHOP does not improve R-CHOP in patients with GCB. The effective rate of treatment and the 2-year survival rate of patients, but for patients with non-GCB type DLBCL with poor prognosis, the addition of lenalidomide can greatly improve the remission rate of the disease and improve the poor prognosis of patients.
So, the investigators initiate this study to evaluate the efficacy of R2-CHOP/R2-EPOCH etc in newly diagnosed highly invasively non-Hodgkin B-cell lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, B-Cell
Keywords
Lenalidomide，rituximab，chemotherapy，highly aggressive B-NHL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
R2-combination chemotherapy
Arm Type
Experimental
Arm Description
R2-CHOP/CHOPE/DA-EPOCH/HD MTX
R2-CHOP :
lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0 Cyclophosphamide 750mg / m2 d1, doxorubicin 70mg / m2 or Doxorubicin liposome 30-40 mg / m2 d2, vincristine 1.4mg / m2 or vindesine 3mg / m2 d2, prednisone 100mg d1-5
R2-DA-EPOCH:
lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0 Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5;
R2-HD MTX:
lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0； MTX 3.5g／ｍ２,ｄ1
Arm Title
R-combination chemotherapy
Arm Type
Active Comparator
Arm Description
R-CHOP/CHOPE/DA-EPOCH/HD MTX
R-CHOP :
Rituximab：375mg/m2，ivgtt，D0 Cyclophosphamide 750mg / m2 d1, doxorubicin 70mg / m2 or Doxorubicin liposome 30-40 mg / m2 d2, vincristine 1.4mg / m2 or vindesine 3mg / m2 d2, prednisone 100mg d1-5
R-DA-EPOCH:
Rituximab：375mg/m2，ivgtt，D0 Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5;
R-HD MTX:
Rituximab：375mg/m2，ivgtt，D0； MTX 3.5g／ｍ２,ｄ1
Intervention Type
Drug
Intervention Name(s)
R2-combination chemotherapy
Intervention Description
R2-CHOP/CHOPE/DA-EPOCH/HD MTX
R2-CHOP :
lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0 Cyclophosphamide 750mg / m2 d1, doxorubicin 70mg / m2 or Doxorubicin liposome 30-40 mg / m2 d2, vincristine 1.4mg / m2 or vindesine 3mg / m2 d2, prednisone 100mg d1-5
R2-DA-EPOCH:
lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0 Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5;
R2-HD MTX:
lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0； MTX 3.5g／ｍ２,ｄ1
Intervention Type
Drug
Intervention Name(s)
R-combination chemotherapy
Intervention Description
R-CHOP/CHOPE/DA-EPOCH/HD MTX
R-CHOP :
Rituximab：375mg/m2，ivgtt，D0 Cyclophosphamide 750mg / m2 d1, doxorubicin 70mg / m2 or Doxorubicin liposome 30-40 mg / m2 d2, vincristine 1.4mg / m2 or vindesine 3mg / m2 d2, prednisone 100mg d1-5
R-DA-EPOCH:
Rituximab：375mg/m2，ivgtt，D0 Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5;
R-HD MTX:
Rituximab：375mg/m2，ivgtt，D0； MTX 3.5g／ｍ２,ｄ1
Primary Outcome Measure Information:
Title
Overall Response Rate after 3 cycles
Description
Percentage of patients with complete remission （CR）or partial remission （PR）
Time Frame
at the end of 3 cycles( each cycle is 21 days)
Title
Overall Response Rate after 6 cycles
Description
Percentage of patients with complete remission （CR）or partial remission （PR）
Time Frame
at the end of 6 cycles( each cycle is 21 days)
Secondary Outcome Measure Information:
Title
Progression free survival（PFS）
Description
Time from enrollment to tumor progression or death
Time Frame
2 years
Title
overall survival（OS）
Description
Time from enrollment to death
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed highly aggressively B-Cell Non-Hodgkin's lymphoma (NHL) confirmed by histopathology
The patient has at least ≥1 measurable tumor lesion with a diameter >1.5 cm;
The patient has not undergone systemic chemotherapy or immunotherapy before;
ECOG score ≤ 2 points;
Liver and kidney function meets the following conditions: creatinine clearance rate ≥ 30ml / min, total bilirubin, AST and ALT ≤ 2.5 × ULN;
No history of malignant tumors within 5 years, except for cured carcinomas in situ such as basal cell carcinoma of the skin, cervical cancer, breast cancer, prostate cancer, etc.;
agree to take contraceptive measures during the trial period and within 3 months after the end of the trial;
Patients volunteered to participate in the study and signed informed consent.
Exclusion Criteria:
Serious cardiovascular and other important organs and blood, endocrine system lesions, and other history of malignant tumors;
Severe mental illness;
Pregnant or lactating women and men or women who intend to conceive in the near future;
The expected survival time is less than 6 months;
HBV, HCV or HIV infection or seropositive;
there are active infections;
Allergies or allergies to rituximab;
Compliance or poor follow-up;
Other circumstances that the investigator believes are not suitable for inclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Wang, MD,PhD
Phone
+86-531-68778331
Email
xinw8331@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao Lv, MD,PhD
Phone
+86-531-68778331
Email
lvxiao8377@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Wang, MD,PhD
Organizational Affiliation
Shandong Provincial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hematology, Provincial Hospital Affiliated to Shandong University
City
Jin'an
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Wang, MD, PHD
Phone
86-531-68778331
Email
xinw8331@163.com
First Name & Middle Initial & Last Name & Degree
Xiao Lv, MD,PHD
Phone
86-531-68778331
Email
lvxiao8377@sina.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
R2 and Combination Chemotherapy Versus R and Combination Chemotherapy in Newly Diagnosed Highly Aggressive B-NHL
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