Clinical trial NCT00440388: Safety & Efficacy Study of AT-101 in Combination w/ Rituximab in Previously Untreated Grade I-II Follicular Non-Hodgkin's Lymphoma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Follicular Lymphoma
Keywords: cancer
lymphoma
Non-Hodgkin's
Non-Hodgkins
AT-101
AT101
Rituxan
Rituximab
Lead sponsor: Ascenta Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-02-27
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Further Study Details provided by Ascenta.

Eligibility criteria: 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;

Primary outcomes:
measure: complete or partial remission of disease
timeFrame: 8 weeks
Secondary outcomes:
measure: duration of complete or partial remission of disease
timeFrame: 10 months
measure: number of participants with adverse events
timeFrame: 10 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Hematology Oncology Associates
state: Arizona
city: Aurora
country: United States
facility: Rocky Mountain Cancer Center-Aurora
state: Colorado
city: Hudson
country: United States
facility: Florida Cancer Institute
state: Florida
city: New Port Richey
country: United States
facility: Florida Cancer Institute
state: Florida
city: Arlington Heights
country: United States
facility: Cancer Care & Hematology Specialists of Chicagoland
state: Illinois
city: Fishers
country: United States
facility: Central Indiana Cancer Centers
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Albuquerque
country: United States
facility: Hematology/Oncology Associates
state: New Mexico
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Northwest Cancer Specialists
state: Oregon
city: Germantown
country: United States
facility: The Jones Clinic
state: Tennessee
city: Bedford
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Dallas
country: United States
facility: Texas Cancer Center at Medical City
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Midland
country: United States
facility: Allison Cancer Center
state: Texas
city: New Braunfels
country: United States
facility: HOAST - New Braunfels
state: Texas
city: Odessa
country: United States
facility: West Texas Cancer Center
state: Texas
city: Richardson
country: United States
facility: Hematology Oncology Physicians of Texas
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Chesapeake
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Salem
country: United States
facility: Oncology and Hematology Associates of SW Virginia, Inc.
state: Virginia
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Huntington
country: United States
facility: St. Mary's Medical Center
state: West Virginia
Study officials:
affiliation: Ascenta Therapeutics, Inc.
name: Lance Leopold, MD
role: STUDY_DIRECTOR
References: