Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Improving the Efficacy of Treatment in Diffused Large B Cell Lymphoma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01793844
Recruitment Status : Unknown
Verified December 2015 by Tongyu Lin, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : February 18, 2013
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
Tongyu Lin, Sun Yat-sen University

Brief Summary:
This is a prospective , open, multicenter, randomized phase Ⅲ study. The investigators planed to include 732 untreated CD20 positive diffused large B cell lymphoma adults,to random to R-CHOP21, CHOP14 , R-CHOP14 regimen groups after signature the informed consents. The patients will receive safety assessment every cycles, and efficacy evaluation every 2 cycles. Every-two-months follow up will be received after finishing the treatment.

Condition or disease
Diffuse Large B-cell Lymphoma

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 732 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Prospective , Multicenter, Randomized Phase III Study of Improving the Efficacy of Treatment in Diffused Large B Cell Lymphoma Patients
Study Start Date : January 2008
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Group/Cohort
A (R-CHOP21)

CHOP combined with Rituximab regimen(R-CHOP21)

Treatment Arm A(R-CHOP21): Rituximab 375mg/m2 for injection on day1; cyclophosphamide(C), 750mg/m2 for injection on day2; doxorubicin(H), 50mg/m2 for injection on day2; and Vincristine(O), 1.4mg/m2 for injection on day2, prednisone(P) 60mg/m2 orally on days 2 to 6. The therapy was repeated every 21 days for a total of 6 cycles.

B (CHOP14)
Biweekly CHOP regimen (CHOP14) Treatment Arm B (CHOP14): cyclophosphamide(C), 750mg/m2 for injection on day1; doxorubicin(H), 50mg/m2 for injection on day1; and Vincristine(O), 1.4 mg/m2 for injection on day1, prednisone(P) 60mg/m2 orally on days 1 to 5. The therapy was repeated every 14 days for a total of 6 cycles.PS: G-CSF 1.0-2ug/kg/ d for subcutaneous injections will be administered on day 6 for a total use of 6-8 days.
C (R-CHOP14)
Biweekly CHOP combined with Rituximab regimen(R-CHOP14) Treatment Arm C (R-CHOP14): Rituximab 375mg/m2 for injection on day1; cyclophosphamide(C), 750mg/m2 for injection on day2; doxorubicin(H), 50mg/m2 for injection on day2; and Vincristine(O), 1.4mg/m2 for injection on day2, prednisone(P),60mg/m2 orally on days 2 to 6. The therapy was repeated every 14 days for a total of 6 cycles.PS: G-CSF 1.0-2ug/kg/ d for subcutaneous injections will be administered on day 7 for a total use of 6-8 days patients with bulky disease or extranodal lesion wil be received radiotherapy after finishing the chemotherapy.



Primary Outcome Measures :
  1. disease free survival [ Time Frame: 5-year ]

Secondary Outcome Measures :
  1. 5-year overall survival [ Time Frame: 5-year ]
  2. response rate [ Time Frame: 5-year ]
  3. Number of participants with SAE [ Time Frame: 5-year ]
  4. quality of life [ Time Frame: 5-year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
untreated CD20 positive Difussed large B cell lymphoma adults
Criteria

Inclusion Criteria:

  • Age ≥18 and ≤70 years old.
  • Histological documented untreated CD20(+) diffused large B cell lymphoma.
  • Measurable disease and evaluable lesion.
  • Never previously treated with radiotherapy, chemotherapy or surgery for malignant disease.
  • Normal Haematological,liver and kidney function (Neutrophil count ≥ 1.5 × 109/L ,hemoglobin ≥ 100g/L,platelets ≥ 100 × 109/L)
  • ECOG Performance status 0-3,Life expectancy of at least 3 months.
  • Without history of another malignancy
  • Without any conflict serious systemic disease
  • Without any accompany treatment(including steroids drugs)
  • Subjects must have signed and informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
  • Female subjects must be practicing and effective methods of birth control for at least 6 months throughout and after study; and have a negative serum β-hCG pregnancy test at screening.

Exclusion Criteria

  • Patients with prior clinical study within 3 months.
  • Secondary lymphoma induced by chemotherapy or radiotherapy for another malignancy
  • Transformed lymphoma
  • Primary central nervous system lymphoma or primary testis lymphoma
  • History of allergic reaction to any ectogenic proteins
  • Prior treatment for lymphoma .
  • History of another malignancy
  • Neutrophil count < 1.0× 109/L ,hemoglobin < 90g/L,platelets < 90 × 109/L,concurrent treatment with systemic antibiotic or antiviral drug for active infection.
  • Decompensated heart failure, dilated cardiomyopathy, coronary artery disease with depression of ST-T for electrocardiogram, myocardial infarction within 6 months
  • Serious infective or organic disease
  • Kidney dysfunction not related to lymphoma(Creatinine clearance≥ 2× institutional upper limit of normal)
  • liver dysfunction not related to lymphoma(transaminase≥3× institutional upper limit of normal,and/or bilirubin≥2.0mg/dl)
  • clinical syndrome of encephalon functional disorder,serious psychosis
  • female subject who is pregnant or breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793844


Contacts
Layout table for location contacts
Contact: Lin TongYu 86-20-87343356 tongyulin@hotmail.com
Contact: Huang Yan 86-20-87343565 ehuangyancn@yahoo.com.cn

Locations
Layout table for location information
China, Guangdong
Tumor center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Lin TongYu    86-20-87343356    tongyulin@hotmail.com   
Contact: Huang Yan    86-20-87343565    ehuangyancn@yahoo.com.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Layout table for investigator information
Study Chair: Lin TongYu Sun Yat-sen University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Tongyu Lin, vice chairman of department of medical oncology, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01793844    
Other Study ID Numbers: CSWOG0001
First Posted: February 18, 2013    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015
Keywords provided by Tongyu Lin, Sun Yat-sen University:
diffuse large B cell lymphoma
DFS
OS
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin