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

February 18, 2016 updated by: Lund University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 221 85
        • Lund University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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)
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University Hospital

Collaborators

Bayer

Investigators

  • Principal Investigator: Ola Lindén, MD, Lund University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 26, 2008

First Posted (Estimate)

September 29, 2008

Study Record Updates

Last Update Posted (Estimate)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 18, 2016

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6th radioimmunotherapy prot.
  • EudraCT number: 2007-002762-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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