NCT00031642

Brief Summary

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and deliver cancer-killing substances to them without harming normal cells. Radiolabeled monoclonal antibodies can locate and deliver radioactive cancer-killing substances. PURPOSE: Phase I/II trial to study the effectiveness of combining radiolabeled monoclonal antibodies with rituximab in treating patients who have non-Hodgkin's lymphoma that has not responded to high-dose chemotherapy and autologous stem cell transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 lymphoma

Timeline
Completed

Started Jan 2002

Typical duration for phase_1 lymphoma

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

January 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2002

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

3.8 years

First QC Date

March 8, 2002

Last Update Submit

December 20, 2023

Conditions

Lymphoma

Keywords

recurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult Burkitt lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose

  • Safety and efficacy

Interventions

rituximabBIOLOGICAL
yttrium Y 90 ibritumomab tiuxetanRADIATION

Eligibility Criteria

Age19 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of relapsed B-cell non-Hodgkin's lymphoma (NHL) after high-dose chemotherapy and autologous stem cell transplantation
  • Less than 25% bone marrow involvement with NHL as evidenced by unilateral or bilateral biopsy within the past 6 weeks
  • o Bone marrow biopsy should demonstrate 15-20% of cellular space occupied by normal hematopoiesis
  • CD20 antigen expression in tumor tissue within the past year as evidenced by 1 of the following:
  • Immunoperoxidase stains of tissue showing positive reactivity with L26 antibody
  • Flow cytometry studies
  • Measurable disease
  • o More than 2 cm bidimensionally
  • years of age and over
  • Performance status WHO 0-2
  • Life expectancy at least 3 months
  • Absolute neutrophil count greater than 1,500/mm\^3
  • Platelet count greater than 150,000/mm\^3
  • Bilirubin less than 2.0 mg/dL
  • SGOT or SGPT no greater than 2.5 times upper limit of normal (unless due to lymphomatous infiltration of the liver)
  • +9 more criteria

You may not qualify if:

  • No active CNS lymphoma
  • No HIV- or AIDS-related lymphoma
  • No transfusion dependency
  • No active obstructive hydronephrosis
  • Not pregnant or nursing/negative pregnancy test
  • No active infection requiring oral or IV antibiotics
  • No human antimurine antibody positivity
  • No other major medical problems
  • No dependency on hematopoietic growth factors (e.g., epoetin alfa, interleukin-11, filgrastim \[G-CSF\], or sargramostim \[GM-CSF\])
  • No prior radioimmunotherapy
  • No other concurrent biologic therapy of any kind
  • No prior fludarabine
  • No concurrent chemotherapy
  • No concurrent steroids except as maintenance for non-cancerous disease
  • No prior pelvic radiotherapy
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eppley Cancer Center at University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Rituximabibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Julie M Vose, MD

    University of Nebraska

    STUDY CHAIR

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

March 8, 2002

First Posted

January 27, 2003

Study Start

January 1, 2002

Primary Completion

November 1, 2005

Study Completion

March 1, 2008

Last Updated

December 27, 2023

Record last verified: 2023-12

Locations

US(1)