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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: Active Phase 2 study of Lymphoma and Mantle Cell Lymphoma, sponsored by Eastern Cooperative Oncology Group.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS is defined as time from randomization to lymphoma progression or death. Progression is defined as: * Appearance of any new lesion \>1.5 cm in any axis during or at the end of therapy * \>=50% increase from nadir in the sum of products of the diameters (SPD) of any previously involved nodes or extranodal masses, or in a single involved node or extranodal mass, or the size of other lesions. * \>=50% increase in the longest diameter of any single previously identified node or extranodal mass m
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 373 participants |
| Start Date | 2012-08-09 |
| Est. Completion | 2031-09 |
| Phase | Phase 2 |
What the registry record for NCT01415752 still lists
NCT01415752 is an interventional study that assigns participants to a tested intervention. The registered 373 participants enrollment target is mid-sized for trials with a published cap, below the 482-participant average among 299 other Lymphoma trials with a reported enrollment target (23% lower).
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 names 20 study sites across 2 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01415752's enrollment target sits among peer trials
373 24th of 299 higher than 276 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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