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

NCT ID: NCT00761384

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2016-01-31

Brief Summary

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.

Conditions

B-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

90Y-ibritumomab

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.

Group Type: EXPERIMENTAL

90Y-ibritumomab

Intervention Type: DRUG

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.

Interventions

90Y-ibritumomab

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Lund University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ola Lindén, MD

Role: PRINCIPAL_INVESTIGATOR

Lund University Hospital

Locations

Lund University Hospital

Lund, , Sweden

Countries

Sweden

Other Identifiers

EudraCT number: 2007-002762-35

Identifier Type: -

Identifier Source: secondary_id

6th radioimmunotherapy prot.

Identifier Type: -

Identifier Source: org_study_id