Monoclonal Antibody Therapy in Relapsed Non-Hodgkin's After Chemotherapy and Autologous Stem Cell Transplantation

December 20, 2023 updated by: University of Nebraska

Phase I/II Study of IDEC-Y2B8 (Zevalin) for Post Transplant Relapses of B-Cell Non-Hodgkin's Lymphoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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.
  • Determine the safety and efficacy of this regimen in these patients.

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.

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

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198-7680
        • Eppley Cancer Center at University of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

  • 19 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)
  • Creatinine less than 2.0 mg/dL
  • Fertile patients must use effective contraception during and for 6 months after study therapy
  • HIV negative
  • At least 4 weeks since prior growth factors
  • At least 4 weeks since prior biologic therapy
  • At least 4 weeks since any prior cytotoxic chemotherapy (6 weeks for nitrosoureas)
  • At least 4 weeks since prior radiotherapy
  • Recovered from all prior therapy
  • At least 4 weeks since prior immunosuppressants

Exclusion Criteria:

  • 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
  • No prior radiotherapy to more than 25% of estimated bone marrow reserve
  • No concurrent external beam radiotherapy
  • No other concurrent investigational drugs
  • No other concurrent anti-cancer therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety and efficacy
Maximum tolerated dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

Biogen

Investigators

  • Study Chair: Julie M Vose, MD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2002

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

March 8, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimated)

January 27, 2003

Study Record Updates

Last Update Posted (Estimated)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0535-00-FB
  • CDR0000069211 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-V02-1691 (Other Grant/Funding Number: National Cancer Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoma

Clinical Trials on rituximab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe