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

French Innovative Leukemia Organisation

Status and phase

Terminated

Phase 2

Conditions

B-cell Lymphoma

Treatments

Drug: 90Y-DOTA-hLL2

Study type

Interventional

Funder types

Other

Identifiers

NCT00906841

RIT90Y-DOTA-hLL2

Details and patient eligibility

About

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.

Full description

Initial treatment: 6 courses of CHOP-R 14 with evaluation of response before C4 (observation of no change or progression at this time will get the patient off study).

Consolidation : fractionated RIT (8 weeks after the end of R-CHOP: 2 injections of 15 mCi/m2 of 90Y-DOTA-hLL2 and hLL2 at day 1 and day 8).

Enrollment

75 patients

Sex

All

Ages

60 to 80 years old

Volunteers

No Healthy Volunteers

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