Safety Study of Different Doses of hA20 (Veltuzumab) in CD20+ Non-Hodgkin's Lymphoma

August 12, 2021 updated by: Gilead Sciences

A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients With CD20+ Non- Hodgkin's Lymphoma

This study is being done to assess the safety and tolerance of different doses of humanized hA20 in patients with NHL.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

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

  • France
    • Cedex
      • Lille, Cedex, France, 59037
        • Service des Maladies du Sang
    • Pierre Benite Cedex
      • Lyon, Pierre Benite Cedex, France, 69495
        • Centre Hospitalier Lyon
  • United Kingdom
      • Leicester, United Kingdom, LE1 9HN
        • University of Leicester

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, >18 years old
  • Histological diagnosis of CD20+ B-cell NHL (all grades) by WHO lymphoma criteria
  • Failed at least one prior standard chemotherapy regimen for NHL
  • Failed rituximab treatment for relapsed NHL
  • Measurable NHL disease by CT, with at least one lesion >1.5 cm in one dimension
  • Adequate performance status (>70 Karnofsky scale, 0-1 ECOG) with an estimated life expectancy of at least 6 months
  • Adequate hematologic status, without ongoing transfusional support (hemoglobin ≥ 10 g/dL, ANC ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L)
  • Adequate renal and hepatic function, defined as: creatinine ≤ 1.5 x Institution Upper Limit of Normal (IULN), bilirubin ≤ 1.5 x IULN, AST and ALT ≤ 2.5 x IULN
  • Otherwise, <Grade 1 toxicity at study entry by NCI CTC version 2.0, including recovery from all acute toxicities incurred as a result of previous surgery, radiotherapy or chemotherapy, whether investigational or conventional.
  • At least 6 months beyond previous rituximab treatment, 12 weeks beyond autologous stem cell transplant, 4 weeks beyond chemotherapy, other experimental treatments, or any radiation therapy to the index lesion(s).
  • Ability to provide signed, informed consent

Exclusion Criteria:

  • Pregnant or lactating women. Women of childbearing potential are required to have a negative pregnancy test
  • Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study until at least 12 weeks after the last weekly hA20 infusion.
  • Rituximab resistant, defined as having progressed during or within 6 months of rituximab treatment.
  • Excessive toxicity to rituximab (NCI CTC Grade 3 or 4) or known to be HACA positive
  • Prior radioimmunotherapy, including Zevalin or Bexxar,
  • Prior therapy with other human or humanized monoclonal antibodies, unless HAHA tested and negative
  • Primary CNS lymphoma, HIV lymphoma or transformed lymphoma, or presence of symptomatic CNS metastases or carcinomatous meningitis.
  • Bulky disease by CT, defined as any single mass >10 cm in its greatest diameter
  • Pleural effusion with positive cytology for lymphoma Known to be HIV positive, or hepatitis B or C positive
  • Known autoimmune disease or presence of autoimmune phenomena.
  • Evidence of infection or requiring antibiotics within 5 days.
  • Corticosteroid use within 2 weeks
  • Prior malignancy with less than a 5-year disease-free interval, excluding nonmelanoma skin cancers and carcinoma in situ of the cervix.
  • Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of studyprocedures and follow-up examinations

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
Time Frame
Safety of hA20 with this administration schedule and dosing
Time Frame: first 12 weeks, then over 2 years
first 12 weeks, then over 2 years
tolerance of hA20 with this administration schedule and dosing
Time Frame: first 12 weeks
first 12 weeks
immunogenicity of hA20 with this administration schedule and dosing
Time Frame: first 12 weeks, as needed over 2 years
first 12 weeks, as needed over 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacodynamics of hA20
Time Frame: first 12 weeks, then up to 2 years
first 12 weeks, then up to 2 years
pharmacokinetics hA20
Time Frame: first 12 weeks, then up to 2 years
first 12 weeks, then up to 2 years
assess efficacy
Time Frame: 4 and 12 weeks, then every 3 months for 2 years
4 and 12 weeks, then every 3 months for 2 years

Collaborators and Investigators

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

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2004

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

January 8, 2008

First Submitted That Met QC Criteria

January 16, 2008

First Posted (Estimate)

January 17, 2008

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM-T-hA20-01EU

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 Non-Hodgkin's Lymphoma

Clinical Trials on veltuzumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe