Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Active 18 to 75 Other 805353 UPCC 18406, GSK 106665, NCT00434629

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Abramson Cancer Center of the University of Pennsylvania

Stephen J. Schuster, MD

Principal Investigator

Stephen J. Schuster, MD		Ph: 215-614-1846
		Email: schustes@mail.med.upenn.edu

Sigrid E. Berg, MD		Ph: 215-614-1846
		Email: sigrid.berg@uphs.upenn.edu

U.S.A.
Pennsylvania
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania
		Stephen J. Schuster, MD	Ph: 215-614-1846
			Email: schustes@mail.med.upenn.edu
		Sigrid E. Berg, MD	Ph: 215-614-1846
			Email: sigrid.berg@uphs.upenn.edu
		Stephen John Schuster	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00434629
Information obtained from ClinicalTrials.gov on May 27, 2008