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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
B-cell Lymphoma

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Ola Lindén, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lund University Hospital

Authority:

Sweden: Medical Products Agency

Study ID:

6th radioimmunotherapy prot.

NCT ID:

NCT00761384

Start Date:

April 2008

Completion Date:

Related Keywords:

  • B-Cell Lymphoma
  • B-cell lymphoma
  • Refractory
  • Recurrent
  • 90Y-ibritumomab
  • Stem cells support
  • Dosimetry study
  • Lymphoma
  • Lymphoma, B-Cell

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