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NCT01415752 · ClinicalTrials.gov registry record · Phase 2

Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma

A Phase 2 study of Lymphoma and Mantle Cell Lymphoma, sponsored by Eastern Cooperative Oncology Group.

Active
Registry status
Phase 2
Development phase
373
Enrollment target
20
Study locations

NCT01415752 is a Phase 2 study of Lymphoma and Mantle Cell Lymphoma that is active but no longer recruiting, run by Eastern Cooperative Oncology Group. The registered enrollment target is 373 participants, below the 482-participant average among 299 other Lymphoma trials with a reported enrollment target (23% lower). The trial reports 20 study locations across 2 states.

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The verdict

NCT01415752, a Phase 2 study of Lymphoma and Mantle Cell Lymphoma, is active but no longer recruiting, sponsored by Eastern Cooperative Oncology Group.

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

Study Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of mantle cell lymphoma by blocking blood flow to the cancer. It is not yet known whether giving rituximab together with bendamustine and bortezomib is more effective than rituximab and bendamustine, followed by rituximab alone or with lenalidomide in treating mantle cell lymphoma. PURPOSE: This randomized phase II trial studies rituximab, bortezomib, bendamustine, and lenalidomide in treating previously untreated older patients with mantle cell lymphoma.

Interventions

  • DRUG Bendamustine
  • BIOLOGICAL rituximab
  • DRUG lenalidomide
  • DRUG bortezomib

Study Locations (20)

California

  • Kaiser Permanente-Deer Valley Medical Center - Antioch
  • Kaiser Permanente, Fremont - Fremont
  • Kaiser Permanente - Fresno
  • Los Angeles County-USC Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles
  • Kaiser Permanente-Modesto - Modesto
  • Kaiser Permanente-Oakland - Oakland
  • Kaiser Permanente-Redwood City - Redwood City
  • Kaiser Permanente-Richmond - Richmond
  • Kaiser Permanente-Roseville - Roseville
  • Kaiser Permanente-South Sacramento - Sacramento
  • Kaiser Permanente - Sacramento - Sacramento
  • Kaiser Permanente-San Francisco - San Francisco
  • Kaiser Permanente-Santa Teresa-San Jose - San Jose
  • Kaiser Permanente San Leandro - San Leandro

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

Trial Details

FieldValue
Enrollment Target 373 participants
Start Date 2012-08-09
Est. Completion 2031-09
Phase Phase 2

Sponsor

Eastern Cooperative Oncology Group

141 total trials

What the Registry Record Tells You About NCT01415752

The ClinicalTrials.gov registry entry for NCT01415752 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 373 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 299 other Lymphoma trials with a reported enrollment target (23% lower). The listed sponsor is Eastern Cooperative Oncology Group, which has 141 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Bendamustine is the first listed.

NCT01415752 reports 20 study locations spanning 2 distinct geographic areas - top geographies include California, Alaska.

Frequently Asked Questions

What is clinical trial NCT01415752 about?

NCT01415752 is a clinical study titled "Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma". RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine...

What is the current status of trial NCT01415752?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 373 participants. The study started on 2012-08-09. Estimated completion is 2031-09.

What conditions does trial NCT01415752 study?

This clinical trial studies the following conditions: Lymphoma, Mantle Cell Lymphoma.

What interventions are being tested in trial NCT01415752?

The interventions under investigation include: Bendamustine (DRUG), rituximab (BIOLOGICAL), lenalidomide (DRUG), bortezomib (DRUG).

Who is sponsoring clinical trial NCT01415752?

This trial is sponsored by Eastern Cooperative Oncology Group, which has 141 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01415752 being conducted?

This trial has 20 study locations across Alaska, California. 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.