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

B-cell Lymphoma Clinical Trial

— HITT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761384
• Other study ID #: 6th radioimmunotherapy prot.
• Secondary ID: EudraCT number:
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 26, 2008
• Last updated: February 18, 2016
• Start date: April 2008
• Est. completion date: January 2016

Study information

• Verified date: April 2015
• Source: Lund University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Sweden	Lund University Hospital	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Lund University Hospital	Bayer

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal tolerable dose (MTD) absorbed dose to the liver, safety and time to treatment failure (TTF)		5 years	Yes
Secondary	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	No