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

Follicular Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440388
• Other study ID #: AT-101-CS-203
• 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

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin

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