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

B-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00906841
• Other study ID #: RIT90Y-DOTA-hLL2
• Status: Terminated
• Phase: Phase 2
• First received: May 18, 2009
• Last updated: April 26, 2018
• Start date: October 2007
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: French Innovative Leukemia Organisation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: April 2018
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• 90Y-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)

Locations

Country	Name	City	State
France	Chu/Clcc Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
French Innovative Leukemia Organisation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event free survival (EFS)		EFS post treatment (at 2 years)
Secondary	Objective disease response (CR, CRu and PR), SD and disease progression		OS after treatment
Secondary	Duration of response		Time interval from the date on which a response (CR, CRu and PR)
Secondary	Time to disease progression		Time interval from the date from initial of study treatment until the date on which disease progression is documented

External Links

•   FILO Internet site