High Dose, Absorbed Dose Adjusted 90Y-ibritumomab With Peripheral Blood Stem Cells (PBSC) Support in B-cell Lymphoma

Study Overview
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Brief Summary
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90Y-ibritumomab given with stem cells support, based on absorbed dose escalation to the liver. Absorbed dose escalation starts at 12 Gy and is capped at 36 Gy to the liver.

Official Title
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A Prospective Study With Individually Adjusted High Dose 90Y-Ibritumomab Tiuxetan Treatment With Peripheral Blood Stem Cells Support to Improve Outcome for Patients With Refractory/Recurrent B-cell Lymphoma, Stage II-IV

Conditions
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B-cell Lymphoma

Intervention / Treatment
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* Drug: 90Y-ibritumomab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed concent Age at least 18 years WHO Performance status 0-3 Histologically verified B-cell lymphoma Diffuse large B-cell lymphoma and follicular grade III, failing an anthracycline containing regimen and patients not found suitable for a second line chemotherapy consolidated by high dose chemotherapy (HDCT) with stem cell support or radiotherapy Transformed B-cell lymphoma, failing first line therapy and not suitable for high dose chemotherapy (HDCT) or with a history of HDCT with stem cell support Follicular lymphoma grade II and I, and other indolent lymphomas must have failed second line treatment. One of these treatments must have contained chemotherapy and rituximab, the latter either together with chemotherapy or as maintenance. The lymphoma must require treatment, Mantle cell lymphoma, failing first line treatment,treatment required Measurable disease and the tumor burden must be acceptable according to the investigator Radiological studies must be performed and a unilateral bone marrow biopsy within 4 weeks before start of treatment Bone marrow reserve likely to give a harvest of at least 2x10 6 peripheral CD34+ stemcells or the existence of such a harvest or a corresponding central harvest Total bilirubin should not exceed 40 micromole/L A GFR as measured by Cystatin C of 50 ml/min HIV, Hepatitis B and C status known Life expectancy of at least 3 months. Exclusion Criteria: Known or clinical evidence of CNS involvement Bone marrow involvement at harvest as measured by biopsy and flow cytometry Subjects with prior radiation to a field that includes over or equal 25% of their red marrow, liver or lung or to both kidneys Prior chemotherapy or radiotherapy within 4 weeks Subjects who are pregnant or nursing Pulmonary involvement, that is not negligible at the discretion of the investigator Liver involvement of lymphoma History of hepatitis B or C.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 90Y-ibritumomab<br>90Y-ibritumomab given with stem cells support, based on absorbed dose escalation to the liver. Absorbed dose escalation starts at 12 Gy and is capped at 36 Gy to the liver. | Drug: 90Y-ibritumomab<br>* 90Y-ibritumomab given with stem cells support, based on absorbed dose escalation to the liver. Absorbed dose escalation starts at 12 Gy and is capped at 36 Gy to the liver.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal tolerable dose (MTD) absorbed dose to the liver, safety and time to treatment failure (TTF) |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response (OR), complete response (CR), their duration, absorbed dose to normal organ and tumours, relapse pattern, the effect of radioimmunotherapy (RIT) in its own right as assessed by positron emission tomography (PET) |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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B-cell lymphoma, Refractory, Recurrent, 90Y-ibritumomab, Stem cells support, Dosimetry study