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

This study is currently recruiting participants.
Verified June 2012 by Lund University Hospital

First Received on September 26, 2008.  
Last Updated on June 8, 2012  
History of Changes
This Clinical Trial Sponsored By: Lund University Hospital
Collaborator: Bayer
Information provided by (Responsible Party): Lund University Hospital
ClinicalTrials.gov Identifier: NCT00761384
 

Purpose for Clinical Trial

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 Study Intervention Clinical Trial Phase
B-cell Lymphoma Drug: 90Y-ibritumomab Phase 1
Phase 2

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Study 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:

MedlinePlus related topics:
Lymphoma

U.S. FDA Resources

Further study details as provided by Lund University Hospital:

Primary Outcome Measures For Clinical Trial:

  • Maximal tolerable dose (MTD) absorbed dose to the liver, safety and time to treatment failure (TTF) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures For Clinical Trial:

  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: April 2008
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Arms

Assigned Study 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 2×10 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761384

Contacts
Contact: Ola Lindén, MD PhD +46 46 17 10 00 ola.linden@med.lu.se

Locations
Sweden
Lund University Hospital Recruiting
Lund, Sweden, 221 85
Contact: Karin Fritz, RN     +46 46 17 10 00     karin.fritz@skane.se    
Principal Investigator: Ola Lindén, MD PhD            
Sponsors and Collaborators
Lund University Hospital
Bayer
Investigators
Principal Investigator: Ola Lindén, MD Lund University Hospital
  More Information

No publications provided

Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT00761384    
History of Changes
Other Study ID Numbers: 6th radioimmunotherapy prot., EudraCT number: 20

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