NCT00064246

Brief Summary

Phase I/II trial to study the effectiveness of combining yttrium Y 90 ibritumomab tiuxetan with rituximab in treating patients who have localized or recurrent lymphoproliferative disorder after an organ transplant. Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells

Trial Health

80
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 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

July 1, 2003

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

1.2 years

First QC Date

July 8, 2003

Last Update Submit

January 24, 2013

Conditions

Post-transplant Lymphoproliferative DisorderRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaStage III Adult Burkitt LymphomaStage III Adult Diffuse Large Cell LymphomaStage IV Adult Burkitt LymphomaStage IV Adult Diffuse Large Cell LymphomaWaldenström Macroglobulinemia

Outcome Measures

Primary Outcomes (1)

  • Response rate

    Estimated using binomial proportions and their 95% confidence intervals.

    Up to 4 years

Secondary Outcomes (3)

  • Time to response

    Up to 4 years

  • Time to progression

    From the date of first study treatment to the first date when progressive disease is documented, assessed up to 4 years

  • Incidence of toxicity related dose reductions graded according to the NCI CTCAE version 3.0

    Up to 4 years

Study Arms (1)

Treatment (rituximab, yttrium Y 90 ibritumomab tiuxetan)

EXPERIMENTAL

Phase I: Patients receive rituximab IV and indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo 2 (or 3 if needed) imaging scans between days 1-6. In the absence of altered biodistribution, patients receive rituximab IV followed within 4 hours by IDEC-Y2B8 IV over 10 minutes on day 8. Phase II: Patients receive treatment as in phase I at the MTD of IDEC-Y2B8. Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years.

Biological: rituximabRadiation: indium In 111 ibritumomab tiuxetanRadiation: yttrium Y 90 ibritumomab tiuxetan

Interventions

rituximabBIOLOGICAL

Given IV

Also known as: IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8, Rituxan
Treatment (rituximab, yttrium Y 90 ibritumomab tiuxetan)
indium In 111 ibritumomab tiuxetanRADIATION

Given IV

Also known as: IDEC-In2B8
Treatment (rituximab, yttrium Y 90 ibritumomab tiuxetan)
yttrium Y 90 ibritumomab tiuxetanRADIATION

Given IV

Also known as: 90Y ibritumomab tiuxetan, IDEC Y2B8, Y90 Zevalin, Y90-labeled ibritumomab tiuxetan
Treatment (rituximab, yttrium Y 90 ibritumomab tiuxetan)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed post-transplant lymphoproliferative disorder (PTLD) of 1 of the following stages:
  • Stage III or IV
  • Localized (not amenable to localized radiotherapy or excision)
  • Recurrent
  • The following histologies\* are eligible:
  • Polyclonal PTLD
  • Monoclonal PTLD
  • Diffuse large B-cell non-Hodgkin's lymphoma (NHL)
  • Lymphoplasmacytic NHL
  • Burkitt/Burkitt-like NHL
  • Must not have completely responded during OR progressed after prior rituximab with or without chemotherapy
  • No history of rapid disease progression while receiving prior chemotherapy
  • Measurable disease
  • Must have less than 25% bone marrow involvement with lymphoma
  • Prior solid organ transplantation required
  • +30 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIDS - Associated Malignancies Clinical Trials Consortium

Rockville, Maryland, 20850, United States

Location

MeSH Terms

Conditions

Burkitt LymphomaLymphoma, Large B-Cell, DiffuseWaldenstrom Macroglobulinemia

Interventions

RituximabIndiumibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsMetals, HeavyElementsInorganic ChemicalsMetals

Study Officials

  • David Scadden

    AIDS Associated Malignancies Clinical Trials Consortium

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 8, 2003

First Posted

July 9, 2003

Study Start

July 1, 2003

Primary Completion

September 1, 2004

Last Updated

January 25, 2013

Record last verified: 2013-01

Locations

US(1)