NCT00761384

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2008

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 19, 2016

Status Verified

April 1, 2015

Enrollment Period

7.8 years

First QC Date

September 26, 2008

Last Update Submit

February 18, 2016

Conditions

B-cell Lymphoma

Keywords

B-cell lymphomaRefractoryRecurrent90Y-ibritumomabStem cells supportDosimetry study

Outcome Measures

Primary Outcomes (1)

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

    5 years

Secondary Outcomes (1)

  • 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)

    5 years

Study Arms (1)

90Y-ibritumomab

EXPERIMENTAL

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

Interventions

90Y-ibritumomabDRUG

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.

90Y-ibritumomab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University Hospital

Lund, 221 85, Sweden

Location

MeSH Terms

Conditions

Lymphoma, B-CellRecurrence

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ola Lindén, MD

    Lund University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2008

First Posted

September 29, 2008

Study Start

April 1, 2008

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 19, 2016

Record last verified: 2015-04

Locations

SE(1)