Cinobufacini Tablets Combined With Chemotherapeutic Protocol in Treatment of Diffuse Large B Cell Lymphoma

NCT02871869 | Unknown Phase 2 DMC

• 1 other identifier: XinjiangMU2016(015)V2.0
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diffuse, Large B-Cell, Lymphoma

Keywords

Cinobufacini Tablets; CHOP protocol

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  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 Outcomes (4)

• Overall response rate (ORR)

  2 years

• overall survival rate (OS)

  3 years

• Safety and Tolerability

  2 years

• Relationship between synergistic effect of Cinobufacini Tablets and expression of Na+/K+-ATPase α3

  2 years

Study Arms (4)

Control group A

ACTIVE COMPARATOR

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.

Drug: vindesine; Drug: cyclophosphamide; Drug: Epirubicin; Drug: prednisone tablets; Drug: Rituximab

Trial group A

EXPERIMENTAL

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.

Drug: vindesine; Drug: cyclophosphamide; Drug: Epirubicin; Drug: prednisone tablets; Drug: Cinobufacini Tablets; Drug: Rituximab

Control group B

ACTIVE COMPARATOR

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.

Drug: vindesine; Drug: cyclophosphamide; Drug: Epirubicin; Drug: prednisone tablets

Trial group B

EXPERIMENTAL

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.

Drug: vindesine; Drug: cyclophosphamide; Drug: Epirubicin; Drug: prednisone tablets; Drug: Cinobufacini Tablets

Interventions

vindesine DRUG

3 mg/㎡ (maximum dosage: \<4mg), d1, 21 d as a cycle, for 4～6 cycles

Also known as: eldisine

Control group A; Control group B; Trial group A; Trial group B

cyclophosphamide DRUG

750 mg/㎡, d1, 21 d as a cycle, for 4～6 cycles

Also known as: endoxan

Control group A; Control group B; Trial group A; Trial group B

Epirubicin DRUG

60 mg/㎡, d1, 21 d as a cycle, for 4～6 cycles

Also known as: EPI

Control group A; Control group B; Trial group A; Trial group B

prednisone tablets DRUG

100 mg, d1～5, 21 d as a cycle, for 4～6 cycles

Also known as: metacortandracin

Control group A; Control group B; Trial group A; Trial group B

Cinobufacini Tablets DRUG

0.3 g per tablet, 3 tablets per time, tid., p.o., until progressive disease or intolerable drug toxicities

Also known as: buformin

Trial group A; Trial group B

Rituximab DRUG

375mg/㎡,one day before CHOP protocol

Also known as: RTX

Control group A; Trial group A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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;

Sponsors & Collaborators

• Xinjiang Medical University: lead

Study Sites (1)

Cancer Hospital Affiliated to Xinjiang Medical University

Ürümqi, Xinjiang, 830011, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Vindesine; Cyclophosphamide; Epirubicin; Prednisone; huachansu; Buformin; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Biguanides; Guanidines; Amidines; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Shun-E Yang, Professor

  Cancer Hospital Affiliated to Xinjiang Medical University

  STUDY CHAIR

Central Study Contacts

Shun-E Yang, Professor

CONTACT

13669926688; yangshune@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Xinjiang Medical University

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 18, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2021
• Last Updated: July 17, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)