B-cell Lymphoma
Conditions
Keywords
Disseminated diffuse large B-cell lymphoma, first line treatment, R CHOP, 90Y-DOTA-hLL2, Patients older than 60 years
Brief 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.
Detailed 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).
Interventions
DRUG90Y-DOTA-hLL2
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)
Sponsors
French Innovative Leukemia Organisation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free survival (EFS) | EFS post treatment (at 2 years) |
Secondary
| Measure | Time frame |
|---|---|
| Objective disease response (CR, CRu and PR), SD and disease progression | OS after treatment |
| Duration of response | Time interval from the date on which a response (CR, CRu and PR) |
| Time to disease progression | Time interval from the date from initial of study treatment until the date on which disease progression is documented |
Countries
France
Outcome results
None listed