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

Primary Purpose

B-cell Lymphoma

Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
90Y-ibritumomab
Sponsored by
Lund University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-cell Lymphoma focused on measuring B-cell lymphoma, Refractory, Recurrent, 90Y-ibritumomab, Stem cells support, Dosimetry study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lund University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

90Y-ibritumomab

Arm Description

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.

Outcomes

Primary Outcome Measures

Maximal tolerable dose (MTD) absorbed dose to the liver, safety and time to treatment failure (TTF)

Secondary Outcome Measures

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)

Full Information

First Posted
September 26, 2008
Last Updated
February 18, 2016
Sponsor
Lund University Hospital
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00761384
Brief Title
High Dose, Absorbed Dose Adjusted 90Y-ibritumomab With Peripheral Blood Stem Cells (PBSC) Support in B-cell Lymphoma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University Hospital
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Lymphoma
Keywords
B-cell lymphoma, Refractory, Recurrent, 90Y-ibritumomab, Stem cells support, Dosimetry study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
90Y-ibritumomab
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
90Y-ibritumomab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximal tolerable dose (MTD) absorbed dose to the liver, safety and time to treatment failure (TTF)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
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)
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ola Lindén, MD
Organizational Affiliation
Lund University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lund University Hospital
City
Lund
ZIP/Postal Code
221 85
Country
Sweden

12. IPD Sharing Statement

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

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