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NCT01856192 · ClinicalTrials.gov registry record · Phase 2

Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma

A Phase 2 study of Ann Arbor Stage II Diffuse Large B-Cell Lymphoma and Ann Arbor Stage III Diffuse Large B-Cell Lymphoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
349
Enrollment target
20
Study locations

NCT01856192 is a Phase 2 study of Ann Arbor Stage II Diffuse Large B-Cell Lymphoma and Ann Arbor Stage III Diffuse Large B-Cell Lymphoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 349 participants, above the 37-participant average among 3 other Ann Arbor Stage II Diffuse Large B-Cell Lymphoma trials with a reported enrollment target (843% higher). The trial reports 20 study locations across 4 states.

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The verdict

NCT01856192, a Phase 2 study of Ann Arbor Stage II Diffuse Large B-Cell Lymphoma and Ann Arbor Stage III Diffuse Large B-Cell Lymphoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
349 participants
Enrollment target
20
Study locations

Study Summary

This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether rituximab and combination chemotherapy are more effective when given with or without lenalidomide in treating patients with diffuse large B cell lymphoma.

Conditions Studied

Ann Arbor Stage II Diffuse Large B-Cell Lymphoma Ann Arbor Stage III Diffuse Large B-Cell Lymphoma Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma

Interventions

  • DRUG Cyclophosphamide
  • OTHER Laboratory Biomarker Analysis
  • DRUG Doxorubicin Hydrochloride
  • DRUG Lenalidomide
  • DRUG Prednisone

Study Locations (20)

California

  • Kaiser Permanente-Deer Valley Medical Center - Antioch
  • Sutter Auburn Faith Hospital - Auburn
  • Kaiser Permanente-Baldwin Park - Baldwin Park
  • Kaiser Permanente-Bellflower - Bellflower
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
  • Kaiser Permanente South Bay - Harbor City
  • Kaiser Permanente-Irvine - Irvine
  • Loma Linda University Medical Center - Loma Linda
  • Memorial Medical Center - Modesto
  • Palo Alto Medical Foundation-Camino Division - Mountain View
  • Palo Alto Medical Foundation-Gynecologic Oncology - Mountain View

Alaska

  • Alaska Breast Care and Surgery LLC - Anchorage
  • Alaska Women's Cancer Care - Anchorage
  • Anchorage Oncology Centre - Anchorage
  • Katmai Oncology Group - Anchorage
  • Providence Alaska Medical Center - Anchorage

Arizona

  • Mayo Clinic in Arizona - Scottsdale
  • Banner University Medical Center - Tucson - Tucson
  • University of Arizona Cancer Center-North Campus - Tucson

Arkansas

  • John L McClellan Memorial Veterans Hospital - Little Rock

Trial Details

FieldValue
Enrollment Target 349 participants
Start Date 2013-08-27
Est. Completion 2026-12-31
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01856192

The ClinicalTrials.gov registry entry for NCT01856192 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 349 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 37-participant average among 3 other Ann Arbor Stage II Diffuse Large B-Cell Lymphoma trials with a reported enrollment target (843% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Ann Arbor Stage II Diffuse Large B-Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT01856192 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Alaska, Arizona.

Frequently Asked Questions

What is clinical trial NCT01856192 about?

NCT01856192 is a clinical study titled "Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma". This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to gr...

What is the current status of trial NCT01856192?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 349 participants. The study started on 2013-08-27. Estimated completion is 2026-12-31.

What conditions does trial NCT01856192 study?

This clinical trial studies the following conditions: Ann Arbor Stage II Diffuse Large B-Cell Lymphoma, Ann Arbor Stage III Diffuse Large B-Cell Lymphoma, Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma.

What interventions are being tested in trial NCT01856192?

The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Doxorubicin Hydrochloride (DRUG), Lenalidomide (DRUG), Prednisone (DRUG).

Who is sponsoring clinical trial NCT01856192?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01856192 being conducted?

This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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