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

Sponsor
French Innovative Leukemia Organisation (Other)
Overall Status
Terminated
CT.gov ID
NCT00906841
Collaborator
(none)
75
Enrollment
1
Location
1
Arm
126
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
N/A
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
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Apr 1, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Event free survival (EFS) [EFS post treatment (at 2 years)]

    Secondary Outcome Measures

    1. Objective disease response (CR, CRu and PR), SD and disease progression [OS after treatment]

    2. Duration of response [Time interval from the date on which a response (CR, CRu and PR)]

    3. Time to disease progression [Time interval from the date from initial of study treatment until the date on which disease progression is documented]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    French Innovative Leukemia Organisation
    ClinicalTrials.gov Identifier:
    NCT00906841
    Other Study ID Numbers:
    • RIT90Y-DOTA-hLL2
    First Posted:
    May 21, 2009
    Last Update Posted:
    Apr 27, 2018
    Last Verified:
    Apr 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    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

    Study Results

    No Results Posted as of Apr 27, 2018