Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Lund University Hospital Identifier:
First received: September 26, 2008
Last updated: February 18, 2016
Last verified: April 2015
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.

Condition Intervention Phase
B-cell Lymphoma
Drug: 90Y-ibritumomab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Lund University Hospital:

Primary Outcome Measures:
  • Maximal tolerable dose (MTD) absorbed dose to the liver, safety and time to treatment failure (TTF) [ Time Frame: 5 years ]

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) [ Time Frame: 5 years ]

Enrollment: 7
Study Start Date: April 2008
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00761384

Lund University Hospital
Lund, Sweden, 221 85
Sponsors and Collaborators
Lund University Hospital
Principal Investigator: Ola Lindén, MD Lund University Hospital
  More Information

Responsible Party: Lund University Hospital Identifier: NCT00761384     History of Changes
Other Study ID Numbers: 6th radioimmunotherapy prot.
EudraCT number: 2007-002762-35
Study First Received: September 26, 2008
Last Updated: February 18, 2016

Keywords provided by Lund University Hospital:
B-cell lymphoma
Stem cells support
Dosimetry study

Additional relevant MeSH terms:
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin processed this record on April 28, 2017