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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2018-04-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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B-cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

90Y-DOTA-hLL2

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

Other Intervention Names

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consolidation

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No