CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
bortezomib +9 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01267812
NCT01267812Phase 2Completed
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A Phase II Study of Weekly Maintenance Bortezomib and Rituximab in Mantle Cell Lymphoma Post Autologous Hematopoietic Cell Transplantation

City of Hope Medical Center·interventional·Posted Dec 29, 2010·Updated Jul 27, 2023

In Brief

A Phase 2 clinical trial evaluating bortezomib, rituximab, and 8 other interventions for Contiguous Stage II Mantle Cell Lymphoma and 5 related conditions. Completed, enrolled 23 participants across 2 sites.

Detailed Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib and rituximab together works in treating patients with mantle cell lymphoma who have previously undergone stem cell transplantation

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContiguous Stage II Mantle Cell Lymphoma, Noncontiguous Stage II Mantle Cell Lymphoma, Recurrent Mantle Cell Lymphoma, Stage I Mantle Cell Lymphoma, Stage III Mantle Cell Lymphoma, Stage IV Mantle Cell Lymphoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 29, 2010
Enrollment StartOct 3, 2011
Primary CompletionNov 2, 2020
TodayJul 2, 2026
Enrollment to primary: 9.1 yearsPosted 15.5 years ago

Interventions

bortezomibdrug

Given SC or IV

rituximabbiological

Given IV

laboratory biomarker analysisother

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immunohistochemistry staining methodother

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RNA analysisgenetic

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gene expression analysisgenetic

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DNA analysisgenetic

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pharmacological studyother

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pharmacogenomic studiesother

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Questionnaire Administrationother