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NCT01030536 · ClinicalTrials.gov registry record · Phase 1

Safety Study of CAT-8015 to Treat Advanced B-cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia (NHL or CLL)

A Phase 1 study of Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma, sponsored by MedImmune.

Completed
Registry status
Phase 1
Development phase
23
Enrollment target
8
Study locations

NCT01030536 is a Phase 1 study of Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma that has completed, run by MedImmune. The registered enrollment target is 23 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (87% lower). The trial reports 8 study locations across 8 states.

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The verdict

NCT01030536, a Phase 1 study of Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma, has completed, sponsored by MedImmune.

COMPLETED
Registry status
Phase 1
Development phase
23 participants
Enrollment target
8
Study locations

Study Summary

The primary objectives of this study are to determine the maximum tolerated dose (MTD) or optimal biologic dose (OBD) and safety profile of CAT-8015 in participants with relapsed or refractory advanced B-cell NHL (diffuse large B-cell lymphoma \[DLBCL\], follicular lymphoma \[FL\], mantle cell lymphoma \[MCL\]) or CLL.

Conditions Studied

Chronic Lymphocytic Leukemia Non-Hodgkin Lymphoma

Interventions

  • DRUG CAT-8015 20 mcg/kg
  • DRUG CAT-8015 30 mcg/kg
  • DRUG CAT-8015 40 mcg/kg
  • DRUG CAT-8015 50 mcg/kg
  • DRUG CAT-8015 60 mcg/kg

Study Locations (8)

California

  • Research Site - Los Angeles

Indiana

  • Research Site - Indianapolis

Maryland

  • Research Site - Bethesda

Nevada

  • Research Site - Las Vegas

South Carolina

  • Research Site - Charleston

Tennessee

  • Research Site - Nashville

Texas

  • Research Site - Temple

Other

  • Research Site - Lodz

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2010-02-15
Est. Completion 2013-03-04
Phase Phase 1

Sponsor

MedImmune

210 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01030536

The ClinicalTrials.gov registry entry for NCT01030536 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (87% lower). The listed sponsor is MedImmune, which has 210 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which CAT-8015 20 mcg/kg is the first listed.

NCT01030536 reports 8 study locations spanning 8 distinct geographic areas - top geographies include California, Indiana, Maryland.

Frequently Asked Questions

What is clinical trial NCT01030536 about?

NCT01030536 is a clinical study titled "Safety Study of CAT-8015 to Treat Advanced B-cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia (NHL or CLL)". The primary objectives of this study are to determine the maximum tolerated dose (MTD) or optimal biologic dose (OBD) and safety profile of CAT-8015 in participants with relapsed or refractory advanced B-cell NHL (diffuse large B-cell lymphoma \[DLBCL\], follicular lymphoma \[FL\], mantle cell lymph...

What is the current status of trial NCT01030536?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2010-02-15. Estimated completion is 2013-03-04.

What conditions does trial NCT01030536 study?

This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma.

What interventions are being tested in trial NCT01030536?

The interventions under investigation include: CAT-8015 20 mcg/kg (DRUG), CAT-8015 30 mcg/kg (DRUG), CAT-8015 40 mcg/kg (DRUG), CAT-8015 50 mcg/kg (DRUG), CAT-8015 60 mcg/kg (DRUG).

Who is sponsoring clinical trial NCT01030536?

This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01030536 being conducted?

This trial has 8 study locations across California, Indiana, Maryland, Nevada, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.