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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


Phase 2
80 Years
N/A
Open (Enrolling)
Both
Diffuse Large B-cell Lymphoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluating efficacy of R-miniCHOP by overall survival

Outcome Time Frame:

2 years overall survival

Safety Issue:

Yes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

LNH03-7B

NCT ID:

NCT01087424

Start Date:

April 2006

Completion Date:

April 2010

Related Keywords:

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

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