Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144755
Status:
COMPLETED
Last Update Posted:
2015-09-02
First Post:
2005-09-02
Brief Title:
R-CHOP-14 Versus R-CHOP-21 and Darbepoetin Alpha in Patients Aged 60-80 Years With Diffuse Large B-cell Lymphoma
Sponsor:
Lymphoma Study Association
Organization:
Lymphoma Study Association
Study Overview
Official Title:
Intensified CHOP Plus Rituximab R-CHOP 14 Versus CHOP Plus Rituximab R-CHOP 21 and FrontlineProphylactic Darbepoetin Alfa Treatment Versus Usual Symptomatic Treatment of Anemia in Patients Aged 60 to 80 Years With Diffuse Large B-cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a multicentric randomized trial evaluating the efficacy and safety of R-CHOP given every 14 days compared to R-CHOP given every 21 days in association or not with darbepoetin alfa in order to maintain hemoglobin above 13 gdl compared to classical symptomatic treatment of anemia in patients aged from 60 to 80 years with diffuse large B-cell lymphoma
Detailed Description:
In patients aged 60 to 75 years with diffuse large B-cell lymphoma the shortening of interval between the courses of CHOP combination CHOP-14 improves the complete response rate the progression free survival and the overall survival
The addition of Rituximab to standard CHOP R-CHOP has also been shown to improve complete remission rate CR event-free survival EFS and overall survival OS in elderly patients with B-DLCL
The aim of this study is to test the hypothesis that the increase of the dose intensity by shortening the interval between two courses of R-CHOP R-CHOP-14could further improve the results of the R-CHOP
Anemia is frequent at diagnosis and during the treatment of aggressive lymphoma In the previous LNH 98-5 study 72 of the patients had at the diagnosis a hemoglobin level inferior to 13 gdl Moreover during the treatment 92 of the patients had a hemoglobin level less than 13 gdl and 30 were transfused The presence of anemia at diagnosis is an indicator of poor prognosis in multivariate analysis This prognosis impact could probably be explained at cellular level on the tumor Tumoral hypoxia is increased by the presence of anemia Due to this hypoxia the expression of tumor growth factor may be increased ea VEGF and the induction of expression of multi drug resistance MDR1 is observed This resistance to treatment is also due to the inhibition of genotoxic activity of free radicals induced by ionised radiation and chemotherapy Experimentally the negative impact of hypoxia on the efficacy of chemotherapy has been demonstrated in sarcoma cell lines for doxorubicin vincristine and all most cyclophosphamide Finally hypoxia induced over expression of apoptosis resistance genes and induced a growth advantage for apoptosis resistant tumoral lines Improvement of survival in patients receiving erythropoetin with chemotherapy or radiotherapy was suggested in a study on patients treated with a neoadjuvant radiochemotherapy for head and neck cancer Erythropoetin could act to protect several normal tissues during chemotherapy and thus could decrease treatment related morbidity Darbepoetin alfa is a new recombinant protein stimulating erythropoiesis Thus the use of darbepoetin alfa in association with chemotherapy could increase CR rate EFS and OS in patients treated for diffuse large B-cell lymphoma
This study is a multicentric phase III open-label randomized trial evaluating the efficacy and safety of R-CHOP given every 14 days compared to R-CHOP given every 21 days in association or not with darbepoetin alfa in order to maintain hemoglobin above 13 gdl compared to classical symptomatic treatment of anemia in patients aged 66 to 80 years with not previously treated diffuse large B-cell lymphoma with at least one adverse prognostic factor of the age adjusted IPI
The addition of Rituximab to standard CHOP R-CHOP has also been shown to improve complete remission rate CR event-free survival EFS and overall survival OS in elderly patients with B-DLCL
The aim of this study is to test the hypothesis that the increase of the dose intensity by shortening the interval between two courses of R-CHOP R-CHOP-14could further improve the results of the R-CHOP
Anemia is frequent at diagnosis and during the treatment of aggressive lymphoma In the previous LNH 98-5 study 72 of the patients had at the diagnosis a hemoglobin level inferior to 13 gdl Moreover during the treatment 92 of the patients had a hemoglobin level less than 13 gdl and 30 were transfused The presence of anemia at diagnosis is an indicator of poor prognosis in multivariate analysis This prognosis impact could probably be explained at cellular level on the tumor Tumoral hypoxia is increased by the presence of anemia Due to this hypoxia the expression of tumor growth factor may be increased ea VEGF and the induction of expression of multi drug resistance MDR1 is observed This resistance to treatment is also due to the inhibition of genotoxic activity of free radicals induced by ionised radiation and chemotherapy Experimentally the negative impact of hypoxia on the efficacy of chemotherapy has been demonstrated in sarcoma cell lines for doxorubicin vincristine and all most cyclophosphamide Finally hypoxia induced over expression of apoptosis resistance genes and induced a growth advantage for apoptosis resistant tumoral lines Improvement of survival in patients receiving erythropoetin with chemotherapy or radiotherapy was suggested in a study on patients treated with a neoadjuvant radiochemotherapy for head and neck cancer Erythropoetin could act to protect several normal tissues during chemotherapy and thus could decrease treatment related morbidity Darbepoetin alfa is a new recombinant protein stimulating erythropoiesis Thus the use of darbepoetin alfa in association with chemotherapy could increase CR rate EFS and OS in patients treated for diffuse large B-cell lymphoma
This study is a multicentric phase III open-label randomized trial evaluating the efficacy and safety of R-CHOP given every 14 days compared to R-CHOP given every 21 days in association or not with darbepoetin alfa in order to maintain hemoglobin above 13 gdl compared to classical symptomatic treatment of anemia in patients aged 66 to 80 years with not previously treated diffuse large B-cell lymphoma with at least one adverse prognostic factor of the age adjusted IPI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None