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An Open-label, Multicenter, Phase II Study of AT-101 in Combination With Rituximab in Patients With Untreated, Grade I-II, Follicular Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Follicular Lymphoma

Thank you

Trial Information

An Open-label, Multicenter, Phase II Study of AT-101 in Combination With Rituximab in Patients With Untreated, Grade I-II, Follicular Non-Hodgkin's Lymphoma


Further Study Details provided by Ascenta.


Inclusion Criteria:



- Histologically confirmed, previously untreated Grade I-II follicular B-cell
non-Hodgkin's lymphoma (stage I, II, III and IV). Patients may have received
radiation therapy to one lymph node region; Stage I or II patients must have
relapsed after prior radiation therapy to be eligible;

- Patients with any FLIPI score may participate. Patients with FLIPI scores 3-5 may be
enrolled with asymptomatic disease, or without worsening disease or disease
related-symptoms; however patients with FLIPI scores of 0-2 must have evidence of
worsening disease;

- ECOG performance status 0-1;

- Measurable disease;

- Adequate hematological function as indicated by:

- Absolute neutrophil count (ANC) >1,000/µL; +Hemoglobin >8
g/dL (It is acceptable to transfuse PRBC to achieve this criterion);

- Platelet count >50 x 109/L.

- Adequate hepatic and renal function as indicated by:

- Serum creatinine ≤2.0 mg/dL;

- Serum albumin ≥2.5 g/dL;

- Total bilirubin ≤1.5 x upper limit of normal (ULN);

- Serum AST and ALT ≤1.5 x ULN.

- Able to swallow and retain oral medication

Exclusion Criteria:

- Patients who have severe lymphoma-related symptoms requiring a rapid response to
therapy (e.g., requirement for cytoreduction due to advanced disease or organ
compromise, respiratory compromise because of large effusions or airway obstruction,
bowel obstruction, ureteral obstruction, and chylous ascites);

- Active symptomatic fungal, bacterial and/or viral infection including, but not
limited to active HIV or viral hepatitis (A, B or C);

- History of hepatitis B infection;

- Any B-cell, T-cell or transformed lymphoma other than histologically confirmed
follicular non-Hodgkin's lymphoma;

- Central nervous system (CNS) lymphoma, CNS or leptomeningeal involvement by lymphoma
(treated or in remission), HIV-related lymphoma, or patients with symptoms suggesting
HIV infection;

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

complete or partial remission of disease

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Lance Leopold, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ascenta Therapeutics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

AT-101-CS-203

NCT ID:

NCT00440388

Start Date:

October 2006

Completion Date:

November 2008

Related Keywords:

  • Follicular Lymphoma
  • cancer
  • lymphoma
  • Non-Hodgkin's
  • Non-Hodgkins
  • AT-101
  • AT101
  • Rituxan
  • Rituximab
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

Name

Location

Texas Oncology, P.A.Dallas, Texas  75246
St. Mary's Medical CenterHuntington, West Virginia  25701
Virginia Oncology AssociatesNewport News, Virginia  23606
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Missouri Cancer AssociatesColumbia, Missouri  65201
Tyler Cancer CenterTyler, Texas  75702
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Cancer Care NorthwestSpokane, Washington  99202
Duke University Medical CenterDurham, North Carolina  27710
New York Oncology Hematology, P.C.Albany, New York  12208
University of Michigan Cancer CenterAnn Arbor, Michigan  48109
Florida Cancer InstituteNew Port Richey, Florida  34652
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Minnesota Oncology Hematology, P.A.Minneapolis, Minnesota  55407
Texas Cancer Center at Medical CityDallas, Texas  75230
Allison Cancer CenterMidland, Texas  79701
West Texas Cancer CenterOdessa, Texas  79761
Hematology/Oncology AssociatesAlbuquerque, New Mexico  87102
The Jones ClinicGermantown, Tennessee  38138
Hematology Oncology AssociatesPhoenix, Arizona  85012
Cancer Care & Hematology Specialists of ChicagolandNiles, Illinois  60714
HOAST - New BraunfelsNew Braunfels, Texas  78131
Northwest Cancer SpecialistsPortland, Oregon  97225
Rocky Mountain Cancer Center-AuroraAurora, Colorado  
Hematology Oncology Physicians of TexasRichardson, Texas  75080
Oncology and Hematology Associates of SW Virginia, Inc.Salem, Virginia  24153