Clinical trial NCT00906841: Study of 90Y-DOTA-hLL2 as a Consolidation Therapy After R-CHOP in Patients With Diffuse Large B-cell Lymphoma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: B-cell Lymphoma
Keywords: Disseminated diffuse large B-cell lymphoma
first line treatment
R CHOP
90Y-DOTA-hLL2
Patients older than 60 years
Lead sponsor: French Innovative Leukemia Organisation
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 75
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Event free survival (EFS)
timeFrame: EFS post treatment (at 2 years)
Secondary outcomes:
measure: Objective disease response (CR, CRu and PR), SD and disease progression
timeFrame: OS after treatment
measure: Duration of response
timeFrame: Time interval from the date on which a response (CR, CRu and PR)
measure: Time to disease progression
timeFrame: Time interval from the date from initial of study treatment until the date on which disease progression is documented
Other outcomes:
Locations:
city: Nantes
country: France
facility: Chu/Clcc Nantes
Study officials:
affiliation: French Innovative Leukemia Organisation
name: Françoise KRAEBER BODERE, MDPD
role: PRINCIPAL_INVESTIGATOR
affiliation: French Innovative Leukemia Organisation
name: Pierre SOUBEYRAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kraeber-Bodere F, Pallardy A, Maisonneuve H, Campion L, Moreau A, Soubeyran I, Le Gouill S, Tournilhac O, Daguindau E, Jardel H, Morineau N, Bouabdallah K, Gyan E, Moles MP, Gressin R, Berthou C, Sadot S, Moreau P, Deau B, Bodet-Milin C, Cazeau AL, Garin E, Salaun PY, Vuillez JP, Gouilleux-Gruart V, Barbet J, Wegener WA, Goldenberg DM, Lamy T, Soubeyran P. Consolidation anti-CD22 fractionated radioimmunotherapy with 90Y-epratuzumab tetraxetan following R-CHOP in elderly patients with diffuse large B-cell lymphoma: a prospective, single group, phase 2 trial. Lancet Haematol. 2017 Jan;4(1):e35-e45. doi: 10.1016/S2352-3026(16)30168-5. Epub 2016 Dec 8.