Safety & Efficacy Study of AT-101 in Combination w/ Rituximab in Previously Untreated Grade I-II Follicular Non-Hodgkin's Lymphoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Ascenta Therapeutics
Study ID
NCT00440388
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • AT-101 — DRUG
    AT-101 30 mg orally for 21 of 56 days, every cycle. Cycle = 56 days; Max of 5 cycles.
  • Rituximab — DRUG
    Rituximab 375mg/m2 IV once per week for four weeks during 1st cycle, 375mg/m2 IV once per cycle for cycles 2-5. Cycle = 56 days; Max of 5 cycles.

Study Details

This is a phase II clinical trial in patients who have not received systemic treatment for follicular non-Hodgkin's lymphoma. The study combines rituximab, an approved drug for this disease, with AT-101, an experimental drug. The hypothesis is that by adding AT-101 to the rituximab regimen, improvement to patients' response to the treatment will be observed verses rituximab alone.

Key Dates

Start date
Oct 31, 2006
Status verified
Aug 2010
Primary completion
Nov 30, 2008
Completion
Nov 30, 2008

Study Design

Enrollment
23 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

complete or partial remission of disease [ Time Frame: 8 weeks ]

Locations (28)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35296-
Hematology Oncology AssociatesPhoenixArizona--
Rocky Mountain Cancer Center-AuroraAuroraColorado--
Florida Cancer InstituteHudsonFlorida34667-
Florida Cancer InstituteNew Port RicheyFlorida34655-
Cancer Care & Hematology Specialists of ChicagolandArlington HeightsIllinois--
Central Indiana Cancer CentersFishersIndiana--
University of Michigan Cancer CenterAnn ArborMichigan48109-
Minnesota Oncology Hematology, P.A.MinneapolisMinnesota--
Missouri Cancer AssociatesColumbiaMissouri--
Comprehensive Cancer Centers of NevadaHendersonNevada--
Hematology/Oncology AssociatesAlbuquerqueNew Mexico87106-
New York Oncology Hematology, P.C.AlbanyNew York--
Duke University Medical CenterDurhamNorth Carolina27707-
Northwest Cancer SpecialistsPortlandOregon--
The Jones ClinicGermantownTennessee38138-
Texas Oncology, P.A.BedfordTexas--
Texas Cancer Center at Medical CityDallasTexas--
Texas Oncology, P.A.Fort WorthTexas--
Allison Cancer CenterMidlandTexas--
HOAST - New BraunfelsNew BraunfelsTexas--
West Texas Cancer CenterOdessaTexas--
Hematology Oncology Physicians of TexasRichardsonTexas75080-
Tyler Cancer CenterTylerTexas--
Virginia Oncology AssociatesChesapeakeVirginia--
Oncology and Hematology Associates of SW Virginia, Inc.SalemVirginia24153-
Cancer Care NorthwestSpokaneWashington99202-
St. Mary's Medical CenterHuntingtonWest Virginia25701-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALHematology Oncology Associates· Phoenix, AZRocky Mountain Cancer Center-Aurora· Aurora, COFlorida Cancer Institute· Hudson, FLFlorida Cancer Institute· New Port Richey, FLCancer Care & Hematology Specialists of Chicagoland· Arlington Heights, IL

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