NCT00434629

Brief Summary

Patients with B-cell lymphoma who relapse after autologous transplant tend to have a poor prognosis. Currently, there is no standard treatment for such patients. Bexxar is a radioactive antibody therapy that has shown a 60-80% response rate in non-transplanted patients with relapsed B-cell lymphoma. This study will test the safety and efficacy of Bexxar in the treatment of patients whose B-cell lymphoma has relapsed after an autologous transplant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2007

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

February 1, 2007

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2007

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

8.2 years

First QC Date

February 12, 2007

Last Update Submit

August 15, 2016

Conditions

B-cell LymphomaNon-Hodgkin's Lymphoma

Keywords

lymphomaNon-Hodgkin's lymphomaB-cell lymphomaRadioimmunotherapyBexxartositumomabautologous hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (2)

  • dose-limiting toxicity

    Week 7 after Bexxar

  • maximum tolerated dose

    Week 7 after Bexxar

Secondary Outcomes (3)

  • overall response rate

    Week 13 after Bexxar

  • progression-free survival

    5 years after Bexxar

  • time to treatment failure

    5 years after Bexxar

Interventions

BexxarDRUG

Day 0: Tositumomab, IV (in the vein) followed by test dose of 131I-Tositumomab, IV (in the vein) to determine treatment dose of 131I-Tositumomab. 1-2 weeks after Day 0: Tositumomab, IV (in the vein) followed by therapeutic dose 131I-Tositumomab (in the vein).

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CD20 positive B-cell lymphoma
  • Confirmed relapsed/refractory disease following autologous transplant
  • Age ≤ 75 years
  • Performance status 0 or 1
  • Creatinine ≤ 1.5 or calculated creatinine clearance ≥ 60 ml/min
  • Total bilirubin, AST, and ALT ≤ 1.5 x upper limit of normal (unless bilirubin due to Gilbert's)
  • No active CNS disease
  • No detectable bone marrow involvement by lymphoma on histopathologic bone marrow examination
  • Bone marrow cellularity ≥ 15% on histopathologic bone marrow examination
  • Availability of adequate stored autologous stem cell product (≥ 2 x 106 CD34+ cells/kg)

You may not qualify if:

  • Active infection
  • Pregnant woman are excluded from the study
  • Subjects not using contraceptives are excluded from the study
  • ANC ≤ 1,500/μL and/or platelet count ≤ 100,000/μL
  • Life expectancy of ≤ 2 months
  • Prior anti-B-cell radioimmunotherapy (e.g., Zevalin or Bexxar) \[Patients who have received prior anti-B-cell monoclonal antibody therapy (e.g., rituximab or epratuzumab) will NOT be excluded.\]
  • Prior total body radiation therapy
  • Positive human anti-mouse antibody (HAMA) testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Lymphoma, B-CellLymphoma, Non-HodgkinLymphoma

Interventions

tositumomab I-131

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Stephen J. Schuster, MD

    Abramson Cancer Center, University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2007

First Posted

February 13, 2007

Study Start

February 1, 2007

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

US(1)