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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Phase II Study of Evaluation of Fractionated Radio-immunotherapy With 90Y-DOTA-hLL2 as a Consolidation Therapy After First Line of Chemotherapy in Patients Older Than 60 With Disseminated Diffuse Large B-cell Lymphoma

Conditions
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B-cell Lymphoma

Intervention / Treatment
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* Drug: 90Y-DOTA-hLL2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 90Y-DOTA-hLL2<br>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) | Drug: 90Y-DOTA-hLL2<br>* 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)<br>* Other names: consolidation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event free survival (EFS) |  | EFS post treatment (at 2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Disseminated diffuse large B-cell lymphoma, first line treatment, R CHOP, 90Y-DOTA-hLL2, Patients older than 60 years