CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 53 enrolled
Drug / intervention
rituximab +8 morebiological
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/NCT01412879
NCT01412879Phase 2Completed

A Randomized Phase II Trial of R-HCVAD/MTX/ARA-C Induction Followed by Consolidation With an Autologous Stem Cell Transplant Vs. R-Bendamustine Induction Followed by Consolidation With an Autologous Stem Cell Transplant for Patients ≤ 65 Years of Age With Previously Untreated Mantle Cell Lymphoma

SWOG Cancer Research Network·interventional·Posted Aug 9, 2011·Updated Oct 29, 2021

In Brief

A Phase 2 clinical trial evaluating rituximab, bendamustine hydrochloride, and 7 other interventions for Lymphoma. Completed, enrolled 53 participants across 204 sites.

Detailed 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 also work in different ways to kill more cancer cells or stop them from growing. It is not yet known whether rituximab is more effective with combination chemotherapy or bendamustine hydrochloride in treating patients with mantle cell lymphoma undergoing peripheral blood stem cell transplantation. PURPOSE: This randomized phase II trial studies how well giving rituximab together with combination chemotherapy or bendamustine hydrochloride followed by consolidation chemotherapy and peripheral blood stem cell transplantation works in treating older patients with previously untreated mantle cell lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesUnited States

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 9, 2011
Enrollment StartNov 1, 2011
Primary CompletionFeb 1, 2016
Study CompletionMar 1, 2021
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 14.9 years ago

Interventions

rituximabbiological

Given IV

bendamustine hydrochloridedrug

Given IV

cyclophosphamidedrug

Given IV

cytarabinedrug

Given IV

dexamethasonedrug

Given PO or IV

doxorubicin hydrochloridedrug

Given IV

leucovorin calciumdrug

Given PO or IV

methotrexatedrug

Given IV

vincristine sulfatedrug

Given IV