Bendamustine Combined With Rituximab for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Pharmatech
Study ID
NCT00831597
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bendamustine — DRUG
    120 mg/m2 IV, Days 1, 2 of Cycles 1-6
  • rituximab — DRUG
    375 mg/m2 IV, Day 1 of Cycles 1-6

Study Details

A phase II trial to evaluate the efficacy and safety of combination bendamustine and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. It is hypothesized that the BR combination will produce at least a 70% overall response rate.

Key Dates

Start date
Nov 30, 2008
Status verified
May 2012
Primary completion
Aug 31, 2013
Completion
Sep 30, 2013

Study Design

Enrollment
61 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bendamustine with rituximab
    All patients received combination bendamustine with rituximab

Primary Outcome Measure

Best Overall Response Rate (ORR) of bendamustine in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma [ Time Frame: 1 year for 1st assessment and then 2.5 years for final assessment ]

Locations (33)

FacilityCityStateZIPSite coordinators
Pharmatech Oncology Study SiteBeverly HillsCalifornia90211-
Pharmatech Oncology Study SiteFountain ValleyCalifornia92708-
Pharmatech Oncology Study SiteOxnardCalifornia93030-
Pharmatech Oncology Study SiteWashington D.C.District of Columbia20037-
Pharmatech Oncology Study SiteWashington D.C.District of Columbia20422-
Pharmatech Oncology Study SiteBoynton BeachFlorida33435-
Pharmatech Oncology Study SiteBrooksvilleFlorida34613-
Pharmatech Oncology Study SiteGainesvilleFlorida32605-
Pharmatech Oncology Study SiteTitusvilleFlorida32796-
Pharmatech Oncology Study SiteJolietIllinois60435-
Pharmatech Oncology Study SiteLafayetteIndiana47904-
Pharmatech Oncology Study SiteMuncieIndiana47303-
Pharmatech Oncology Study SiteDubuqueIowa52001-
Pharmatech Oncology Study SitePaducahKentucky42001-
Pharmatech Oncology Study SiteYork VillageMaine03909-
Pharmatech Oncology Study SiteJacksonMississippi39202-
Pharmatech Oncology Study SiteChesterfieldMissouri63017-
Pharmatech Oncology Study SiteCherry HillNew Jersey08003-
Pharmatech Oncology Study SitePhillipsburgNew Jersey08865-
Pharmatech Oncology Study SiteBay ShoreNew York11706-
Pharmatech Oncology Study SiteEast SetauketNew York11733-
Pharmatech Oncology Study SiteThe BronxNew York10467-
Pharmatech Oncology Study SiteAkronOhio44304-
Pharmatech Oncology Study SiteColumbusOhio43219-
Pharmatech Oncology Study SiteBethlehemPennsylvania18015-
Pharmatech Oncology Study SiteGettysburgPennsylvania17325-
Pharmatech Oncology Study SiteHilton HeadSouth Carolina29926-
Pharmatech Oncology Study SiteGermantownTennessee38138-
Pharmatech Oncology Study SiteAustinTexas78759-
Pharmatech Oncology Study SiteCorpus ChristiTexas78463-
Pharmatech Oncology Study SiteFort WorthTexas76104-
Pharmatech Oncology Study SiteLubbockTexas79410-
Pharmatech Oncology Study SiteRichardsonTexas75080-

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Pharmatech Oncology Study Site· Beverly Hills, CAPharmatech Oncology Study Site· Fountain Valley, CAPharmatech Oncology Study Site· Oxnard, CAPharmatech Oncology Study Site· Washington D.C., DCPharmatech Oncology Study Site· Boynton Beach, FLPharmatech Oncology Study Site· Brooksville, FL

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