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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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00906841
First Posted: May 21, 2009
Last Update Posted: March 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
French Innovative Leukemia Organisation
  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: Intervention Model: Single Group Assignment
Masking: None (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 French Innovative Leukemia Organisation:

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

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

Enrollment: 75
Study Start Date: October 2007
Estimated Study Completion Date: July 2018
Primary Completion Date: March 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00906841


Locations
France
Chu/Clcc Nantes
Nantes, France, 44093
Sponsors and Collaborators
French Innovative Leukemia Organisation
Investigators
Principal Investigator: Françoise KRAEBER BODERE, MDPD French Innovative Leukemia Organisation
Principal Investigator: Pierre SOUBEYRAN, MD French Innovative Leukemia Organisation
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: French Innovative Leukemia Organisation
ClinicalTrials.gov Identifier: NCT00906841     History of Changes
Other Study ID Numbers: RIT90Y-DOTA-hLL2
First Submitted: May 18, 2009
First Posted: May 21, 2009
Last Update Posted: March 16, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by French Innovative Leukemia Organisation:
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