Phase II study of mini CHOP plus Rituximab in non previously treated patient aged over 80 years with CD20+ Diffuse Large B-cell Lymphoma - LNH03-7B

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-001589-34-BE

Enrollment

150

Registered

2007-04-25

Start date

2007-06-05

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CD20+ diffuse large B-cell lymphoma

Interventions

Trade Name: MabThera 100mg Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: rituximab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patient with histologically proven CD20+ diffuse large B-cell lymphoma - aged over 80 years - Ann Arbor stage Ibulky, II, III or IV - Age-adjusted International Prognostic Index equal to 1, 2 and 3 - Patient not previously treated - ECOG performance status =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Any other histological type of lymphoma - Any history of treated or non-treated - central nervous system or meningeal involvement by lymphoma - contra-indication to any drug contained in the chemotherapy regimens - any serious active disease - Poor renal function, poor hepatic function 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 o cervical carcinoma - Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study - Adult patient under tutelage

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of R-miniCOP in patients aged over 80 years with not previously treated CD20+ diffuse large B-cell lymphoma as measured by the overall survival (OR);Secondary Objective: To evaluate the efficacy and the safety of R-miniCHOP as measured by EFS events, the response rate at the end of treatment, the progression rate, the DFS for complete responders and unconfirmed complete responders, the additional toxicities and evaluation of simplificated scale prognostic impact.;Primary end point(s): To evaluate the efficacy of R-miniCOP in patients aged over 80 years with not previously treated CD20+ diffuse large B-cell lymphoma as measured by the overall survival (OR)	—

Measure

Time frame

Main Objective: To evaluate the efficacy of R-miniCOP in patients aged over 80 years with not previously treated CD20+ diffuse large B-cell lymphoma as measured by the overall survival (OR);Secondary Objective: To evaluate the efficacy and the safety of R-miniCHOP as measured by EFS events, the response rate at the end of treatment, the progression rate, the DFS for complete responders and unconfirmed complete responders, the additional toxicities and evaluation of simplificated scale prognostic impact.;Primary end point(s): To evaluate the efficacy of R-miniCOP in patients aged over 80 years with not previously treated CD20+ diffuse large B-cell lymphoma as measured by the overall survival (OR)

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026