Mini-CHOP and Rituximab in Patients Aged Over 80 Years

Diffuse Large B-Cell Lymphoma Clinical Trial

Official title:

Phase II Study of Mini-CHOP Plus Rituximab in Non Previously Treated Patients Aged Over 80 Years With CD 20+ Diffuse Large B-Cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087424
• Other study ID #: LNH03-7B
• Status: Completed
• Phase: Phase 2
• Start date: April 2006
• Est. completion date: June 2010

Study information

• Verified date: August 2019
• Source: Lymphoma Study Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate efficacy and safety of R-miniCHOP for elderly patients with diffuse large B-Cell lymphoma (DLBC) Lymphoma aged over 80 years by measuring the overall survival.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

Inclusion Criteria:

• Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification). DLBCL with some small cell infiltration in bone marrow or lymph node may be included.

• Aged over 80 years.

• Ann Arbor stage I bulky, II, III or IV

• Age-adjusted International Prognostic Index equal to 0, 1, 2 and 3.

• Patient non previously treated.

• ECOG performance status = 2.

• With a minimum life expectancy of 3 months.

• Negative HIV, HBV and HCV serologies test = 4 weeks (except after vaccination).

• Having previously signed a written informed consent

Exclusion Criteria:

• Any other histological type of lymphoma.

• Any history of treated or non-treated indolent lymphoma.

• Central nervous system or meningeal involvement by lymphoma.

• Contra-indication to any drug contained in the chemotherapy regimens.

• Any serious active disease (according to the investigator's decision).

• Poor renal function (creatinin level>150µmol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.

• Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless related to bone marrow infiltration.

• Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.

• Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.

• Adult patient under tutelage.

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• R mini CHOP
Prednisone 40 mg/m2 D1 D2 D3 D4 D5 Rituximab 375 mg/m2 D1 Doxorubicine 25 mg/m2 D1 Cyclophosphamide 400 mg/m2 D1 Vincristine 1 mg/m2 D1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lymphoma Study Association

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating efficacy of R-miniCHOP by overall survival		2 years overall survival
Secondary	Evaluating R-miniCHOP efficacy by Event free survival		2 years event free survival