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COMPLETED Phase 2

Safety & Efficacy Study of AT-101 in Combination w/ Rituximab in Previously Untreated Grade I-II Follicular Non-Hodgkin's Lymphoma

NCT00440388 · View on ClinicalTrials.gov ↗

Study Summary

This is a phase II clinical trial in patients who have not received systemic treatment for follicular non-Hodgkin's lymphoma. The study combines rituximab, an approved drug for this disease, with AT-101, an experimental drug. The hypothesis is that by adding AT-101 to the rituximab regimen, improvement to patients' response to the treatment will be observed verses rituximab alone.

Conditions Studied

Interventions

  • DRUG Rituximab
  • DRUG AT-101

Study Locations (20)

Texas

  • Texas Oncology, P.A. — Bedford
  • Texas Cancer Center at Medical City — Dallas
  • Texas Oncology, P.A. — Fort Worth
  • Allison Cancer Center — Midland

Florida

  • Florida Cancer Institute — Hudson
  • Florida Cancer Institute — New Port Richey

Alabama

  • University of Alabama at Birmingham — Birmingham

Arizona

  • Hematology Oncology Associates — Phoenix

Colorado

  • Rocky Mountain Cancer Center-Aurora — Aurora

Illinois

  • Cancer Care & Hematology Specialists of Chicagoland — Arlington Heights

Indiana

  • Central Indiana Cancer Centers — Fishers

Michigan

  • University of Michigan Cancer Center — Ann Arbor

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2006-10
Est. Completion 2008-11
Phase Phase 2

Sponsor

Ascenta Therapeutics

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00440388

The ClinicalTrials.gov registry entry for NCT00440388 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ascenta Therapeutics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Follicular Lymphoma appearing as the primary indexed condition, and to 2 interventions — of which Rituximab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00440388 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Texas, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00440388 about?

NCT00440388 is a clinical study titled "Safety & Efficacy Study of AT-101 in Combination w/ Rituximab in Previously Untreated Grade I-II Follicular Non-Hodgkin's Lymphoma". This is a phase II clinical trial in patients who have not received systemic treatment for follicular non-Hodgkin's lymphoma. The study combines rituximab, an approved drug for this disease, with AT-101, an experimental drug. The hypothesis is that by adding AT-101 to the rituximab regimen, improvem...

What is the current status of trial NCT00440388?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2006-10. Estimated completion is 2008-11.

What conditions does trial NCT00440388 study?

This clinical trial studies the following conditions: Follicular Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00440388?

The interventions under investigation include: Rituximab (DRUG), AT-101 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00440388?

This trial is sponsored by Ascenta Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00440388 being conducted?

This trial has 20 study locations across Alabama, Arizona, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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