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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00906841
Other study ID # RIT90Y-DOTA-hLL2
Secondary ID
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
Health authority
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

Study Design


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
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