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

This study has been terminated.
(completed recruitment of patients on 15 december 2010 : last patients included are in treatment phase the other patients in follow up period)
Sponsor:
Information provided by:
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier:
NCT00906841
First received: May 18, 2009
Last updated: January 25, 2011
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
B-cell Lymphoma
Drug: 90Y-DOTA-hLL2
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:

Primary Outcome Measures:
  • Event free survival (EFS) [ Time Frame: EFS post treatment (at 2 years) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective disease response (CR, CRu and PR), SD and disease progression [ Time Frame: OS after treatment ] [ Designated as safety issue: Yes ]
  • Duration of response [ Time Frame: Time interval from the date on which a response (CR, CRu and PR) ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: October 2007
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 90Y-DOTA-hLL2
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
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)
Other Name: consolidation

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

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906841

Locations
France
Chu/Clcc Nantes
Nantes, France, 44093
Sponsors and Collaborators
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Investigators
Principal Investigator: Françoise KRAEBER BODERE, MDPD Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Principal Investigator: Pierre SOUBEYRAN, MD Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
  More Information

Additional Information:
No publications provided

Responsible Party: RIT90Y-DOTA-hLL2, GOELAMS
ClinicalTrials.gov Identifier: NCT00906841     History of Changes
Other Study ID Numbers: RIT90Y-DOTA-hLL2
Study First Received: May 18, 2009
Last Updated: January 25, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:
Disseminated diffuse large B-cell lymphoma
first line treatment
R CHOP
90Y-DOTA-hLL2
Patients older than 60 years

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on April 17, 2014