- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02871869
Cinobufacini Tablets Combined With Chemotherapeutic Protocol in Treatment of Diffuse Large B Cell Lymphoma
July 12, 2017 updated by: Shun-E Yang, Xinjiang Medical University
Cinobufacini Tablets Combined With R-CHOP Protocol (Rituximab + Vindesine + Cyclophosphamide + Epirubicin + Prednisone)/CHOP in Treatment of Diffuse Large B Cell Lymphoma: A Phase II Randomized, Controlled and Multi-center Study
Diffuse large B cell lymphoma (DLBCL), as the most common subtype non-Hodgkin lymphoma (NHL), has great heterogeneity in clinical manifestations, histological morphology and prognosis.
R-CHOP Protocol (Rituximab + Vindesine + Cyclophosphamide + Epirubicin + Prednisone) is the gold therapeutic criteria for patients with NHL, and it is also used as the first-line treatment for patients with DLBCL.
After treatment, 50%~60%of patients with DLBCL receive complete remission (CR), 30%~40% recurrent and 10% will never be cured due to initial and secondary drug tolerance.
This study aimed to explore whether Cinobufacini Tablets had synergistic effect in the treatment of DLBCL, and whether its action was in close association with the positive expression of Na+/K+-ATPase α3, and to observe the rates of adverse reactions induced by Cinobufacini Tablets during treatment.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Diffuse large B cell lymphoma (DLBCL), as the most common subtype non-Hodgkin lymphoma (NHL), accounts for 30%~40% of adults with NHL, and has great heterogeneity in clinical manifestations, histological morphology and prognosis.
R-CHOP Protocol (Rituximab + Vindesine + Cyclophosphamide + Epirubicin + Prednisone) is the gold therapeutic criteria for patients with NHL, and it is also used as the first-line treatment for patients with DLBCL.
After treatment, 50%~60%of patients with DLBCL receive complete remission (CR), 30%~40% recurrent and 10% will never be cured due to initial and secondary drug tolerance.
The study of Tao Wu et al in domestic showed that cinobufacini combined with CHOP protocol had excellent efficacy in the treatment of NHL, with response rate reaching up to 91.7%, and the adverse reactions were mild and tolerable, whereas the response rate of single CHOP was only 62.5%.
In the clinical practice of our studies, it was also found that some patients with recurrent DLBCL NHL also had shrunken or disappeared tumors and a survival time of more than 2 years after single administration of cinobufacini tablets for 3~6 months following the withdrawal of chemotherapy.
This study aimed to explore whether Cinobufacini Tablets had synergistic effect in the treatment of DLBCL, and whether its action was in close association with the positive expression of Na+/K+-ATPase α3, and to observe the rates of adverse reactions induced by Cinobufacini Tablets during treatment.
Study Type
Interventional
Enrollment (Anticipated)
316
Phase
- Phase 2
- Phase 3
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: Shun-E Yang, Professor
- Phone Number: 13669926688
- Email: yangshune@medmail.com.cn
Study Locations
-
-
Xinjiang
-
Ürümqi, Xinjiang, China, 830011
- Recruiting
- Cancer Hospital affiliated to Xinjiang Medical University
-
Contact:
- Shun-E Yang, Professor
- Phone Number: 13669926688
- Email: yangshune@medmail.com.cn
-
-
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 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
For control and trial groups A:
Inclusion Criteria:
- Patients aged 18-70 years old;
- Patients with eastern Collaborative Oncology Group (ECOG) performance status (PS) score: 0~3 points;
- International prognostic index (IPI): ≤3 points;
- Patients who were diagnosed as diffuse large B cell lymphoma (DLBCL) with initial treatment by histopathology;
- Patients with more than 1 measurable nidus (common CT or MRI scanning diameter ≥ 20 mm, and spiral CT scanning diameter ≥ 10 mm);
- Patients without dysfunction of important organs, and had normal blood routine, hepatorenal function and cardiac function. White blood cell count (WBC) ≥4.0×109/L, neutrophil count ≥1.5×109/L; platelet (PLT) count ≥100×109/L; hemoglobin (HGB) ≥95g/L; serum bilirubin (Bil) ≤1.5 folds of the upper limit of normal value, alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤2 folds of the upper limit of normal value, and serum creatinine (Scr) ≤1.5mg/dl;
- Patients with expected survival time>3 months;
- Patients who were well informed of this study and signed the informed consent forms.
- Patients who received administration of Rituximab.
Exclusion Criteria:
- Patients who did not conform to above criteria;
- Patients who were receiving other anti-cancer therapies;
- Patients with DLBCL affected by primary breast gland, lung, testis, bone, peri-orbit, peri-spine, central nerve system and bone marrow;
- Patients with double expression, double strike, trinary expression and trinary strike and CD5+;
- Patients complicated with other non-DLBCL primary malignant tumors;
- Patients who had poor compliance with their families;
- Patients with one of the following conditions: uncontrolled metastatic nidi of central nerve system, dysfunction of important organs and severe cardiac diseases like congestive heart failure, uncontrollable arrhythmia, angina pectoris that needed long-term drug administration, valvular heart diseases, myocardial infarction and refractory hypertension, pregnancy or lactation, chronic infectious wounds, and history of uncontrollable psychological diseases.
- Patients had previous history of treatment with Cinobufacini Tablets.
For control and trial groups B
Inclusion Criteria:
- Patients aged 18-70 years old;
- Patients with eastern Collaborative Oncology Group (ECOG) performance status (PS) score: 0~3 points;
- International prognostic index (IPI): ≤3 points;
- Patients who were diagnosed as diffuse large B cell lymphoma (DLBCL) with initial treatment by histopathology;
- Patients with more than 1 measurable nidus (common CT or MRI scanning diameter ≥ 20 mm, and spiral CT scanning diameter ≥ 10 mm);
- Patients without dysfunction of important organs, and had normal blood routine, hepatorenal function and cardiac function. White blood cell count (WBC) ≥4.0×109/L, neutrophil count ≥1.5×109/L; platelet (PLT) count ≥100×109/L; hemoglobin (HGB) ≥95g/L; serum bilirubin (Bil) ≤1.5 folds of the upper limit of normal value, alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤2 folds of the upper limit of normal value, and serum creatinine (Scr) ≤1.5mg/dl;
- Patients with expected survival time>3 months;
- Patients who were well informed of this study and signed the informed consent forms.
- Patients who did not receive administration of Rituximab.
Exclusion Criteria:
- Patients who did not conform to above criteria;
- Patients who were receiving other anti-cancer therapies;
- Patients with DLBCL affected by primary breast gland, lung, testis, bone, peri-orbit, peri-spine, central nerve system and bone marrow;
- Patients with double expression, double strike, trinary expression and trinary strike and CD5+;
- Patients complicated with other non-DLBCL primary malignant tumors;
- Patients who had poor compliance with their families;
- Patients with one of the following conditions: uncontrolled metastatic nidi of central nerve system, dysfunction of important organs and severe cardiac diseases like congestive heart failure, uncontrollable arrhythmia, angina pectoris that needed long-term drug administration, valvular heart diseases, myocardial infarction and refractory hypertension, pregnancy or lactation, chronic infectious wounds, and history of uncontrollable psychological diseases.
- Patients had previous history of treatment with Cinobufacini Tablets.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control group A
Control group A was treated with single R-CHOP protocol[Rituximab 375mg/㎡,one day before CHOP protocol, CHOP protocol included vindesine 3 mg/㎡ (maximum dosage: <4mg) d1 plus cyclophosphamide 750 mg/㎡ d1 plus Epirubicin 60 mg/㎡ d1 plus prednisone tablets 100 mg, d1~5], 21 d as a cycle, for 4~6 cycles.
|
3 mg/㎡ (maximum dosage: <4mg), d1, 21 d as a cycle, for 4~6 cycles
Other Names:
750 mg/㎡, d1, 21 d as a cycle, for 4~6 cycles
Other Names:
60 mg/㎡, d1, 21 d as a cycle, for 4~6 cycles
Other Names:
100 mg, d1~5, 21 d as a cycle, for 4~6 cycles
Other Names:
375mg/㎡,one day before CHOP protocol
Other Names:
|
Experimental: Trial group A
Trial group A was treated with Cinobufacini Tablets combined with R-CHOP protocol[Rituximab 375mg/㎡,one day before CHOP protocol, CHOP protocol included vindesine 3 mg/㎡ (maximum dosage: <4mg) d1 plus cyclophosphamide 750 mg/㎡ d1 plus Epirubicin 60 mg/㎡d1 plus prednisone tablets 100 mg, d1~5], 21 d as a cycle, for 4~6 cycles.
|
3 mg/㎡ (maximum dosage: <4mg), d1, 21 d as a cycle, for 4~6 cycles
Other Names:
750 mg/㎡, d1, 21 d as a cycle, for 4~6 cycles
Other Names:
60 mg/㎡, d1, 21 d as a cycle, for 4~6 cycles
Other Names:
100 mg, d1~5, 21 d as a cycle, for 4~6 cycles
Other Names:
375mg/㎡,one day before CHOP protocol
Other Names:
0.3 g per tablet, 3 tablets per time, tid., p.o., until progressive disease or intolerable drug toxicities
Other Names:
|
Active Comparator: Control group B
Control group B was treated with single CHOP protocol[vindesine 3 mg/㎡ (maximum dosage: <4mg) d1 plus cyclophosphamide 750 mg/㎡ d1 plus Epirubicin 60 mg/㎡ d1 plus prednisone tablets 100 mg, d1~5], 21 d as a cycle, for 4~6 cycles.
|
3 mg/㎡ (maximum dosage: <4mg), d1, 21 d as a cycle, for 4~6 cycles
Other Names:
750 mg/㎡, d1, 21 d as a cycle, for 4~6 cycles
Other Names:
60 mg/㎡, d1, 21 d as a cycle, for 4~6 cycles
Other Names:
100 mg, d1~5, 21 d as a cycle, for 4~6 cycles
Other Names:
|
Experimental: Trial group B
Trial group B was treated with Cinobufacini Tablets combined with CHOP protocol[vindesine 3 mg/㎡ (maximum dosage: <4mg) d1 plus cyclophosphamide 750 mg/㎡ d1 plus Epirubicin 60 mg/㎡ d1 plus prednisone tablets 100 mg, d1~5], 21 d as a cycle, for 4~6 cycles.
|
3 mg/㎡ (maximum dosage: <4mg), d1, 21 d as a cycle, for 4~6 cycles
Other Names:
750 mg/㎡, d1, 21 d as a cycle, for 4~6 cycles
Other Names:
60 mg/㎡, d1, 21 d as a cycle, for 4~6 cycles
Other Names:
100 mg, d1~5, 21 d as a cycle, for 4~6 cycles
Other Names:
0.3 g per tablet, 3 tablets per time, tid., p.o., until progressive disease or intolerable drug toxicities
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: 3 years
|
3-year Progression-free survival (PFS) defined as the ratio of study subjects who had disease progression or died within 3 years from the start of randomization.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR)
Time Frame: 2 years
|
Overall response rate (ORR) that defined as the total ratio of study subjects with complete response, complete response unconfirmed and partial response after treatment.
ORR=(CR+ CRu+ PR)cases/total cases×100%.
|
2 years
|
overall survival rate (OS)
Time Frame: 3 years
|
3-year overall survival rate (OS) that defined as the ratio of study subjects who survived 3 years after randomization
|
3 years
|
Safety and Tolerability
Time Frame: 2 years
|
Incidence of Treatment-Emergent adverse events
|
2 years
|
Relationship between synergistic effect of Cinobufacini Tablets and expression of Na+/K+-ATPase α3
Time Frame: 2 years
|
Relationship between synergistic effect of Cinobufacini Tablets and expression of Na+/K+-ATPase α3
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Shun-E Yang, Professor, Cancer Hospital affiliated to Xinjiang Medical University
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
September 1, 2016
Primary Completion (Anticipated)
September 1, 2018
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
August 12, 2016
First Submitted That Met QC Criteria
August 16, 2016
First Posted (Estimate)
August 18, 2016
Study Record Updates
Last Update Posted (Actual)
July 17, 2017
Last Update Submitted That Met QC Criteria
July 12, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
- Lymphoma
- Lymphoma, Large B-Cell, Diffuse
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- 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
- Antibiotics, Antineoplastic
- Cyclophosphamide
- Epirubicin
- Rituximab
- Prednisone
- Vindesine
- Buformin
Other Study ID Numbers
- XinjiangMU2016(015)V2.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Diffuse, Large B-Cell, Lymphoma
-
Memorial Sloan Kettering Cancer CenterRecruitingLymphoma | Lymphoma, B-Cell | DLBCL - Diffuse Large B Cell Lymphoma | Large B-cell Lymphoma | Large-cell Lymphoma | Mediastinal B-Cell Diffuse Large Cell LymphomaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); AmgenActive, not recruitingRecurrent Diffuse Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | CD20 Positive | Stage I Diffuse Large B-Cell Lymphoma | Stage II Diffuse Large B-Cell Lymphoma | Stage III Diffuse Large B-Cell Lymphoma | Stage IV Diffuse Large B-Cell LymphomaUnited States
-
Qian WenbinNot yet recruitingDiffuse Large B Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Relapsed Diffuse Large B-Cell LymphomaChina
-
University Hospital Southampton NHS Foundation...Hoffmann-La RocheTerminatedDiffuse Large B Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Relapsed Diffuse Large B-Cell LymphomaUnited Kingdom
-
National Cancer Institute (NCI)WithdrawnDiffuse, Large B-cell Lymphoma | Lymphoma, Diffuse Large-Cell | Lymphoma, Diffuse Large-Cell B-cell | Large-Cell Lymphoma, Diffuse
-
Dana-Farber Cancer InstituteBayer; AbbVieActive, not recruitingDiffuse Large B Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Relapsed Diffuse Large B-Cell LymphomaUnited States
-
Memorial Sloan Kettering Cancer CenterSanofi; Columbia University; Medical College of Wisconsin; University of Rochester and other collaboratorsActive, not recruitingDiffuse Large B-cell Lymphoma (DLBCL) | Relapsed Diffuse Large B-cell Lymphoma (DLBCL) | Refractory Diffuse Large B-cell Lymphoma (DLBCL)United States
-
Autolus LimitedCompletedDiffuse Large B Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | DLBCL | Relapsed Diffuse Large B-Cell LymphomaUnited States, United Kingdom
-
Herlev HospitalOdense University Hospital; Zealand University Hospital; Aarhus University Hospital and other collaboratorsCompletedDiffuse Large B-cell Lymphoma Recurrent | Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma Cell of Origin
-
UNC Lineberger Comprehensive Cancer CenterCephalonCompletedLymphoma | Diffuse Large B-Cell Lymphoma | Lymphoma, Diffuse Large-Cell | Diffuse Large-Cell LymphomaUnited States
Clinical Trials on vindesine
-
Dermatologic Cooperative Oncology GroupUnknown
-
Japan Clinical Oncology GroupMinistry of Health, Labour and Welfare, JapanCompleted
-
Gustave Roussy, Cancer Campus, Grand ParisCompletedLung CancerFrance, Spain, Australia, United States, Sweden, Belgium, Switzerland, Italy, Egypt, South Africa, Israel, Colombia, Morocco, Norway, Greece, Brazil, Poland, Argentina, Austria, Chile, Czech Republic, Former Yugoslavia, Japan, Lithuania, Macedonia, The Former Yugoslav Republic... and more
-
West Japan Thoracic Oncology GroupCompleted
-
Ottawa Regional Cancer CentreUnknown
-
National Cancer Institute (NCI)Unknown
-
University of CologneCompleted
-
European Lung Cancer Working PartyCompleted
-
European Organisation for Research and Treatment...Medical Research CouncilCompletedCervical CancerUnited Kingdom
-
The First Affiliated Hospital with Nanjing Medical...Not yet recruitingDiffuse Large B-cell Lymphoma