- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00906841
Study of 90Y-DOTA-hLL2 as a Consolidation Therapy After R-CHOP in Patients With Diffuse Large B-cell Lymphoma
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
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Nantes, France, 44093
- Chu/Clcc Nantes
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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)
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Event free survival (EFS)
Time Frame: EFS post treatment (at 2 years)
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EFS post treatment (at 2 years)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective disease response (CR, CRu and PR), SD and disease progression
Time Frame: OS after treatment
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OS after treatment
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Duration of response
Time Frame: Time interval from the date on which a response (CR, CRu and PR)
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Time interval from the date on which a response (CR, CRu and PR)
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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
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Time interval from the date from initial of study treatment until the date on which disease progression is documented
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Collaborators and Investigators
Investigators
- Principal Investigator: Françoise KRAEBER BODERE, MDPD, French Innovative Leukemia Organisation
- Principal Investigator: Pierre SOUBEYRAN, MD, French Innovative Leukemia Organisation
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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.
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