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

NCT00906841 | Terminated Phase 2 DMC

• 1 other identifier: RIT90Y-DOTA-hLL2
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

B-cell Lymphoma

Keywords

Disseminated diffuse large B-cell lymphoma; first line treatment; R CHOP; 90Y-DOTA-hLL2; Patients older than 60 years

Outcome Measures

Primary Outcomes (1)

• Event free survival (EFS)

  EFS post treatment (at 2 years)

Secondary Outcomes (3)

• Objective disease response (CR, CRu and PR), SD and disease progression

  OS after treatment

• Duration of response

  Time interval from the date on which a response (CR, CRu and PR)

• Time to disease progression

  Time interval from the date from initial of study treatment until the date on which disease progression is documented

Study Arms (1)

90Y-DOTA-hLL2

EXPERIMENTAL

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)

Drug: 90Y-DOTA-hLL2

Interventions

90Y-DOTA-hLL2 DRUG

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)

Also known as: consolidation

90Y-DOTA-hLL2

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \< 60 years and \> 80 years
• Other types of lymphomas except CD20+ diffuse large B-cell lymphoma according to the WHO classification
• 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

Sponsors & Collaborators

• French Innovative Leukemia Organisation: lead

Study Sites (1)

Chu/Clcc Nantes

Nantes, 44093, France

Location

Related Publications (1)

• 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.

  PMID: 27964867 DERIVED

Related Links

• FILO Internet site

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Consolidation Chemotherapy

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Françoise KRAEBER BODERE, MDPD

  French Innovative Leukemia Organisation

  PRINCIPAL INVESTIGATOR

• Pierre SOUBEYRAN, MD

  French Innovative Leukemia Organisation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 21, 2009
• Study Start: October 1, 2007
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2018
• Last Updated: April 27, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)