Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma That Has Relapsed After High-Dose Chemotherapy and Autologous Stem Cell Transplantation

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Completed 19 and over Other UNMC-535-00 NCI-V02-1691, NCT00031642

Objectives

1. Determine the maximum tolerated dose of yttrium Y 90-labeled ibritumomab tiuxetan when administered with rituximab in patients with B-cell non-Hodgkin's lymphoma who have relapsed after high-dose chemotherapy and autologous hematopoietic stem cell transplantation.
2. Determine the safety and efficacy of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• 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
  • 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
  • More than 2 cm bidimensionally



• No active CNS lymphoma



• No HIV- or AIDS-related lymphoma

Prior/Concurrent Therapy:

Biologic therapy:

• See Disease Characteristics
• At least 4 weeks since prior growth factors
• At least 4 weeks since prior biologic therapy
• 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

Chemotherapy:

• See Disease Characteristics
• At least 4 weeks since any prior cytotoxic chemotherapy (6 weeks for nitrosoureas)
• No prior fludarabine
• No concurrent chemotherapy

Endocrine therapy:

• No concurrent steroids except as maintenance for non-cancerous disease

Radiotherapy:

• See Biologic therapy
• At least 4 weeks since prior radiotherapy
• No prior pelvic radiotherapy
• No prior radiotherapy to more than 25% of estimated bone marrow reserve
• No concurrent external beam radiotherapy

Surgery:

• Not specified

Other:

• Recovered from all prior therapy
• At least 4 weeks since prior immunosuppressants
• No other concurrent investigational drugs
• No other concurrent anti-cancer therapy

Patient Characteristics:

Age:

• 19 and over

Performance status:

• WHO 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Absolute neutrophil count greater than 1,500/mm³
• Platelet count greater than 150,000/mm³
• No transfusion dependency

Hepatic:

• 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)

Renal:

• Creatinine less than 2.0 mg/dL
• No active obstructive hydronephrosis

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after study therapy
• HIV negative
• No active infection requiring oral or IV antibiotics
• No human antimurine antibody positivity
• No other major medical problems

Expected Enrollment

Approximately 78 patients (20 for phase I and 58 for phase II) will be accrued for this study within 2 years.

Outcomes

Maximum tolerated dose
Safety and efficacy

Outline

This is a dose-escalation study of yttrium Y 90-labeled ibritumomab tiuxetan (IDEC-Y2B8).

• Phase I: Patients receive rituximab IV over 4-6 hours followed by indium In 111-labeled ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0. Patients receive rituximab IV again on day 7 followed by IDEC-Y2B8 IV over 10 minutes.

  Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 3 of 6 patients experience dose-limiting toxicity.




• Phase II: Once the MTD is determined, 58 additional patients are treated at that dose level as in phase I.

Patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Julie Vose, MD, Protocol chair		Ph: 402-559-3848 Email: jmvose@unmc.edu

Registry Information
Official Title		Phase I/II Study of IDEC-Y2B8 (Zevalin) for Post Transplant Relapses of B-Cell Non-Hodgkin's Lymphoma
Trial Start Date		2002-01-03
Registered in ClinicalTrials.gov		NCT00031642
Date Submitted to PDQ		2002-01-04
Information Last Verified		2006-01-10

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