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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


Phase 2
60 Years
80 Years
Not Enrolling
Both
B-cell Lymphoma

Thank you

Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event free survival (EFS)

Outcome Time Frame:

EFS post treatment (at 2 years)

Safety Issue:

Yes

Principal Investigator

Françoise KRAEBER BODERE, MDPD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

RIT90Y-DOTA-hLL2

NCT ID:

NCT00906841

Start Date:

October 2007

Completion Date:

July 2013

Related Keywords:

  • B-Cell Lymphoma
  • Disseminated diffuse large B-cell lymphoma
  • first line treatment
  • R CHOP
  • 90Y-DOTA-hLL2
  • Patients older than 60 years
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

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