Study of 90Y-DOTA-hLL2 as a Consolidation Therapy After R-CHOP in Patients With Diffuse Large B-cell Lymphoma

• Status: Terminated
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase II, multi-centric, open-label, study.

Disseminated diffuse large B-cell lymphoma in patients older than 60: evaluation of fractionated radio-immunotherapy with 90Y-DOTA-hLL2 as a consolidation therapy after first line of chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French Innovative Leukemia Organisation

Criteria

Inclusion Criteria:

• Age > 60 and < 80 years

• Non eligible for stem cell transplantation

• CD20 diffuse large B-cell lymphoma according to the WHO classification

• Bulky stage I and II > ou =7 cm and stage III and IV

• Performance status 0 - 2

• Creatinine clearance >ou = 50 ml/min (Cockroft formula).

• Serum bilirubin < ou =30 mmol/l

• Leucocytes > ou =3 G/l, granulocytes > ou = 1,5 G/l, platelets >ou= 100 G/L.

• HIV negative

• Written informed consent

Exclusion Criteria:

• Age < 60 years and > 80 years

• Other types of lymphomas except CD20+ diffuse large B-cell lymphoma according to the WHO classification

• Histologic transformation of low grade lymphoma (Involvement of the bone marrow by small B-cell lymphoma will not lead to exclusion of the patient)

• Primary lymphoma of the central nervous system and transformed gastro intestinal MALT lymphoma

• Meningeal involvement

• Bone marrow involvement > 25% after R-CHOP

• Aggressive post-transplantation lymphoma

• Absence of CD20 expression on tumor cells

• Non bulky stages I et II

• HIV positive

• Active Hepatitis B or C

• Left ventricular ejection fraction < 50%.

• Contra-indication to R-CHOP treatment

• Previous or concurrent second malignancy except for adequately treated basal cell carcinoma of the skin, curatively treated in situ carcinoma of the cervix, curatively treated solid cancer, with no evidence of disease for at least 5 years

• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

• Participation at the same time in another study in which investigational drugs are used

• Absence of written informed consent