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Anti-CD20 Radioimmunotherapy Before Chemotherapy and Stem Cell Transplant in Treating Patients With High-Risk B-Cell Malignancies

NCT02483000 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2020-11-23

Study results available
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Summary

This phase I/II trial studies the side effects and best dose of anti-cluster of differentiation (CD)20 radioimmunotherapy (RIT), and to see how well it works when given before chemotherapy and stem cell transplant in treating patients with B-cell malignancies that have not responded to treatment or have come back after responding to treatment. CD20 is a protein found on the cells of a type of cancer cell called B-cells. Anti-CD20 RIT attaches radioactive material to a drug that is designed to target CD20, which brings radioactive material to the cancer cells to kill the cells. This may kill more tumor cells while causing fewer side effects to healthy tissue. Adding anti-CD20 to standard chemotherapy and stem cell transplant may be more effective in treating patients with B-cell malignancies.

Conditions

  • Burkitt Lymphoma
  • CD20-Positive Neoplastic Cells Present
  • Diffuse Large B-Cell Lymphoma
  • Indolent Non-Hodgkin Lymphoma
  • Mantle Cell Lymphoma
  • Recurrent B-Cell Non-Hodgkin Lymphoma
  • Refractory Mature B-Cell Non-Hodgkin Lymphoma

Interventions

BIOLOGICAL

Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein

Given IV

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo autologous PBSCT

DRUG

Carmustine

Given IV

DRUG

Clearing Agent

Given IV

DRUG

Cytarabine

Given IV

DRUG

Etoposide

Given IV

RADIATION

Indium In 111-DOTA-Biotin

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Melphalan

Given IV

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo autologous PBSCT

OTHER

Pharmacological Study

Correlative studies

RADIATION

Yttrium Y 90-DOTA-Biotin

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Ajay Gopal · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2019-11-17
Completion
2020-09-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02483000 on ClinicalTrials.gov