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

Sponsor

Ascenta Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00440388

Collaborator

(none)

Enrollment

Locations

Duration (Months)

0.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Follicular Lymphoma	Drug: AT-101 Drug: Rituximab	Phase 2

Detailed Description

Further Study Details provided by Ascenta.

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Outcome Measures

Primary Outcome Measures

complete or partial remission of disease [8 weeks]

Secondary Outcome Measures

duration of complete or partial remission of disease [10 months]
number of participants with adverse events [10 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35296
2	Hematology Oncology Associates	Phoenix	Arizona	United States
3	Rocky Mountain Cancer Center-Aurora	Aurora	Colorado	United States
4	Florida Cancer Institute	Hudson	Florida	United States	34667
5	Florida Cancer Institute	New Port Richey	Florida	United States	34655
6	Cancer Care & Hematology Specialists of Chicagoland	Arlington Heights	Illinois	United States
7	Central Indiana Cancer Centers	Fishers	Indiana	United States
8	University of Michigan Cancer Center	Ann Arbor	Michigan	United States	48109
9	Minnesota Oncology Hematology, P.A.	Minneapolis	Minnesota	United States
10	Missouri Cancer Associates	Columbia	Missouri	United States
11	Comprehensive Cancer Centers of Nevada	Henderson	Nevada	United States
12	Hematology/Oncology Associates	Albuquerque	New Mexico	United States	87106
13	New York Oncology Hematology, P.C.	Albany	New York	United States
14	Duke University Medical Center	Durham	North Carolina	United States	27707
15	Northwest Cancer Specialists	Portland	Oregon	United States
16	The Jones Clinic	Germantown	Tennessee	United States	38138
17	Texas Oncology, P.A.	Bedford	Texas	United States
18	Texas Cancer Center at Medical City	Dallas	Texas	United States
19	Texas Oncology, P.A.	Fort Worth	Texas	United States
20	Allison Cancer Center	Midland	Texas	United States
21	HOAST - New Braunfels	New Braunfels	Texas	United States
22	West Texas Cancer Center	Odessa	Texas	United States
23	Hematology Oncology Physicians of Texas	Richardson	Texas	United States	75080
24	Tyler Cancer Center	Tyler	Texas	United States
25	Virginia Oncology Associates	Chesapeake	Virginia	United States
26	Oncology and Hematology Associates of SW Virginia, Inc.	Salem	Virginia	United States	24153
27	Cancer Care Northwest	Spokane	Washington	United States	99202
28	St. Mary's Medical Center	Huntington	West Virginia	United States	25701