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Safety and Efficacy of Bexxar Therapy in the Treatment of Relapsed/Residual B-Cell Lymphoma After Autologous Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00434629
Recruitment Status : Completed
First Posted : February 13, 2007
Last Update Posted : August 17, 2016
Information provided by:
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
B-cell Lymphoma Non-Hodgkin's Lymphoma Drug: Bexxar Phase 1

Detailed Description:
High-dose chemotherapy followed by autologous stem cell transplantation (ASCT) has become the standard of care for relapsed/refractory chemotherapy-sensitive non-Hodgkin's lymphomas (NHL). However, one-half to two-thirds of such patients will relapse after ASCT, with subsequent poor prognosis, and new therapies are urgently needed for this patient population. Radioimmunotherapy (RIT) as a single agent therapy in patients with CD20 antigen-expressing relapsed or refractory low-grade, follicular, or transformed NHL has demonstrated overall response rates of 60-80% and has been approved by the FDA for use in this setting. While RIT is currently under investigation as a component of conditioning regimens for ASCT, the safety and efficacy of RIT after ASCT has not yet been well described. We will conduct a single-center Phase I dose-escalation trial of Bexxar (Tositumomab and 131I Tositumomab) for treatment of relapsed or residual CD20 antigen-expressing B-cell lymphomas following ASCT. Our primary aim will be to determine the safety, dose-limiting toxicity, and maximum tolerated dose of Bexxar in this post-ASCT patient population. Our secondary aim will be to describe the overall response rate, progression-free survival, time to treatment failure, and overall survival. Should Bexxar prove to be safe in this population, subsequent trials will be designed to investigate further the efficacy of RIT in the post-transplant setting.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Bexxar® (Tositumomab and 131I-Tositumomab) Radioimmunotherapy in Patients With Relapsed or Residual CD20 Antigen-Expressing B-Cell Lymphomas Following Autologous Hematopoietic Stem Cell Transplantation
Study Start Date : February 2007
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Intervention Details:
  • Drug: Bexxar

    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).

Primary Outcome Measures :
  1. dose-limiting toxicity [ Time Frame: Week 7 after Bexxar ]
  2. maximum tolerated dose [ Time Frame: Week 7 after Bexxar ]

Secondary Outcome Measures :
  1. overall response rate [ Time Frame: Week 13 after Bexxar ]
  2. progression-free survival [ Time Frame: 5 years after Bexxar ]
  3. time to treatment failure [ Time Frame: 5 years after Bexxar ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00434629

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United States, Pennsylvania
Abramson Cancer Center, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
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Principal Investigator: Stephen J. Schuster, MD Abramson Cancer Center, University of Pennsylvania
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Responsible Party: Stephen J. Schuster, MD, University of Pennsylvania Identifier: NCT00434629    
Other Study ID Numbers: UPCC 18406
UPenn IRB#805353
GSK 106665
First Posted: February 13, 2007    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016
Keywords provided by University of Pennsylvania:
Non-Hodgkin's lymphoma
B-cell lymphoma
autologous hematopoietic stem cell transplantation
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Iodine-131 anti-B1 antibody
Antineoplastic Agents