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

April 26, 2018 updated by: French Innovative Leukemia Organisation

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44093
        • Chu/Clcc Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • consolidation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event free survival (EFS)
Time Frame: EFS post treatment (at 2 years)
EFS post treatment (at 2 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective disease response (CR, CRu and PR), SD and disease progression
Time Frame: OS after treatment
OS after treatment
Duration of response
Time Frame: Time interval from the date on which a response (CR, CRu and PR)
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
Time interval from the date from initial of study treatment until the date on which disease progression is documented

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Innovative Leukemia Organisation

Investigators

  • Principal Investigator: Françoise KRAEBER BODERE, MDPD, French Innovative Leukemia Organisation
  • Principal Investigator: Pierre SOUBEYRAN, MD, French Innovative Leukemia Organisation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

May 18, 2009

First Submitted That Met QC Criteria

May 20, 2009

First Posted (Estimate)

May 21, 2009

Study Record Updates

Last Update Posted (Actual)

April 27, 2018

Last Update Submitted That Met QC Criteria

April 26, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIT90Y-DOTA-hLL2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe