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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00440388
Other study ID # AT-101-CS-203
Secondary ID
Status Completed
Phase Phase 2
First received February 23, 2007
Last updated August 24, 2010
Start date October 2006
Est. completion date November 2008

Study information

Verified date August 2010
Source Ascenta Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Description:

Further Study Details provided by Ascenta.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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;

Study Design

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


Intervention

Drug:
AT-101
AT-101 30 mg orally for 21 of 56 days, every cycle. Cycle = 56 days; Max of 5 cycles.
Rituximab
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.

Locations

Country Name City State
United States New York Oncology Hematology, P.C. Albany New York
United States Hematology/Oncology Associates Albuquerque New Mexico
United States University of Michigan Cancer Center Ann Arbor Michigan
United States Cancer Care & Hematology Specialists of Chicagoland Arlington Heights Illinois
United States Rocky Mountain Cancer Center-Aurora Aurora Colorado
United States Texas Oncology, P.A. Bedford Texas
United States University of Alabama at Birmingham Birmingham Alabama
United States Virginia Oncology Associates Chesapeake Virginia
United States Missouri Cancer Associates Columbia Missouri
United States Texas Cancer Center at Medical City Dallas Texas
United States Duke University Medical Center Durham North Carolina
United States Central Indiana Cancer Centers Fishers Indiana
United States Texas Oncology, P.A. Fort Worth Texas
United States The Jones Clinic Germantown Tennessee
United States Comprehensive Cancer Centers of Nevada Henderson Nevada
United States Florida Cancer Institute Hudson Florida
United States St. Mary's Medical Center Huntington West Virginia
United States Allison Cancer Center Midland Texas
United States Minnesota Oncology Hematology, P.A. Minneapolis Minnesota
United States HOAST - New Braunfels New Braunfels Texas
United States Florida Cancer Institute New Port Richey Florida
United States West Texas Cancer Center Odessa Texas
United States Hematology Oncology Associates Phoenix Arizona
United States Northwest Cancer Specialists Portland Oregon
United States Hematology Oncology Physicians of Texas Richardson Texas
United States Oncology and Hematology Associates of SW Virginia, Inc. Salem Virginia
United States Cancer Care Northwest Spokane Washington
United States Tyler Cancer Center Tyler Texas

Sponsors (1)

Lead Sponsor Collaborator
Ascenta Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary complete or partial remission of disease 8 weeks No
Secondary duration of complete or partial remission of disease 10 months No
Secondary number of participants with adverse events 10 months Yes
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