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

Primary Purpose

B-cell Lymphoma

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
90Y-DOTA-hLL2
Sponsored by
French Innovative Leukemia Organisation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-cell Lymphoma focused on measuring Disseminated diffuse large B-cell lymphoma, first line treatment, R CHOP, 90Y-DOTA-hLL2, Patients older than 60 years

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu/Clcc Nantes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

90Y-DOTA-hLL2

Arm Description

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)

Outcomes

Primary Outcome Measures

Event free survival (EFS)

Secondary Outcome Measures

Objective disease response (CR, CRu and PR), SD and disease progression
Duration of response
Time to disease progression

Full Information

First Posted
May 18, 2009
Last Updated
April 26, 2018
Sponsor
French Innovative Leukemia Organisation
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1. Study Identification

Unique Protocol Identification Number
NCT00906841
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
completed recruitment of patients on 15 december 2010
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Innovative Leukemia Organisation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Lymphoma
Keywords
Disseminated diffuse large B-cell lymphoma, first line treatment, R CHOP, 90Y-DOTA-hLL2, Patients older than 60 years

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
90Y-DOTA-hLL2
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
90Y-DOTA-hLL2
Other Intervention Name(s)
consolidation
Intervention Description
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)
Primary Outcome Measure Information:
Title
Event free survival (EFS)
Time Frame
EFS post treatment (at 2 years)
Secondary Outcome Measure Information:
Title
Objective disease response (CR, CRu and PR), SD and disease progression
Time Frame
OS after treatment
Title
Duration of response
Time Frame
Time interval from the date on which a response (CR, CRu and PR)
Title
Time to disease progression
Time Frame
Time interval from the date from initial of study treatment until the date on which disease progression is documented

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Françoise KRAEBER BODERE, MDPD
Organizational Affiliation
French Innovative Leukemia Organisation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre SOUBEYRAN, MD
Organizational Affiliation
French Innovative Leukemia Organisation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu/Clcc Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27964867
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.
Results Reference
derived
Links:
URL
http://www.filo-leucemie.org
Description
FILO Internet site

Learn more about this trial

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

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