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COMPLETED Phase 3

S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma

NCT00006721 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells. It is not yet known which monoclonal antibody plus combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is comparing 2 different monoclonal antibodies given together with combination chemotherapy to see how well they work in treating patients with newly-diagnosed non-Hodgkin's lymphoma.

Conditions Studied

Interventions

  • DRUG prednisone
  • DRUG cyclophosphamide
  • BIOLOGICAL rituximab
  • DRUG doxorubicin
  • DRUG vincristine

Study Locations (20)

California

  • Alta Bates Summit Comprehensive Cancer Center — Berkeley
  • Peninsula Medical Center — Burlingame
  • Marin Cancer Institute at Marin General Hospital — Greenbrae
  • Sutter Health - Western Division Cancer Research Group — Greenbrae
  • Desert Regional Medical Center Comprehensive Cancer Center — Palm Springs
  • University of California Davis Cancer Center — Sacramento
  • California Pacific Medical Center - California Campus — San Francisco
  • Stanford Cancer Center — Stanford
  • Sutter Solano Medical Center — Vallejo

Florida

  • Center for Cancer Care and Research at Watson Clinic, LLP — Lakeland
  • Sacred Heart Cancer Center at Sacred Heart Hospital — Pensacola
  • West Florida Cancer Institute at West Florida Hospital - Pensacola — Pensacola

Alaska

  • Alaska Regional Hospital Cancer Center — Anchorage
  • Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital — Fairbanks

Arkansas

  • Hembree Mercy Cancer Center at St. Edward Mercy Medical Center — Fort Smith
  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences — Little Rock

Georgia

  • Piedmont Hospital — Atlanta
  • Northside Hospital Cancer Center — Atlanta

Connecticut

  • Helen and Harry Gray Cancer Center at Hartford Hospital — Hartford

District of Columbia

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center — Washington D.C.

Trial Details

FieldValue
Enrollment Target 571 participants
Start Date 2001-03
Est. Completion 2025-12
Phase Phase 3

Sponsor

SWOG Cancer Research Network

212 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00006721

The ClinicalTrials.gov registry entry for NCT00006721 describes a study currently listed as completed. It is categorized as Phase 3, 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 571 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 212 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 Lymphoma appearing as the primary indexed condition, and to 5 interventions — of which prednisone 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: NCT00006721 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Alaska. 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 NCT00006721 about?

NCT00006721 is a clinical study titled "S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma". RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells. It is not yet known whi...

What is the current status of trial NCT00006721?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 571 participants. The study started on 2001-03. Estimated completion is 2025-12.

What conditions does trial NCT00006721 study?

This clinical trial studies the following conditions: 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 NCT00006721?

The interventions under investigation include: prednisone (DRUG), cyclophosphamide (DRUG), rituximab (BIOLOGICAL), doxorubicin (DRUG), vincristine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00006721?

This trial is sponsored by SWOG Cancer Research Network, which has 212 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00006721 being conducted?

This trial has 20 study locations across Alaska, Arkansas, California, Connecticut, District of Columbia. 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