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

Phase 2

Terminated

• Conditions: B-cell Lymphoma
• Interventions: Drug: 90Y-DOTA-hLL2

• Registration Number: NCT00906841
• Lead Sponsor: French Innovative Leukemia Organisation

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).

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2009-05-18
• Study First Submitted QC: 2009-05-20
• Study First Posted: 2009-05-21
• Primary Completion: 2016-03
• Status Verified: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-26
• Last Update Posted: 2018-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
90Y-DOTA-hLL2	90Y-DOTA-hLL2	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)

Primary Outcome Measures

Name	Time	Method
Event free survival (EFS)	EFS post treatment (at 2 years)

Secondary Outcome Measures

Name	Time	Method
Objective disease response (CR, CRu and PR), SD and disease progression	OS after treatment
Time to disease progression	Time interval from the date from initial of study treatment until the date on which disease progression is documented
Duration of response	Time interval from the date on which a response (CR, CRu and PR)

Trial Locations

Locations (1)

Chu/Clcc Nantes; 🇫🇷 Nantes, France