Clinical trial NCT00086203: Study of Talabostat and Rituximab in Advanced Chronic Lymphocytic Leukemia (CLL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2004-06-29
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: The objective of this study is to assess the efficacy and safety of talabostat and rituximab in patients with advanced CLL who failed to respond, or have progressed following a prior response, to a fludarabine regimen.

Detailed description: Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: INCLUSION CRITERIA:

* Men or women ≥18 years of age
* Histopathologically confirmed diagnosis of B-CLL expressing surface CD20 of any detectable intensity
* Rai Stage III or IV. Rai Stages I and II with massive or progressive lymphadenopathy or hepatosplenomegaly.
* Primary resistance to a fludarabine regimen (no PR or CR) or progressive disease within 1 year of a prior response
* ECOG performance status 0, 1, or 2
* Written informed consent

EXCLUSION CRITERIA:

* Therapy for CLL within 4 weeks of Study Day 1 (including chemotherapy, radiation, immunotherapy, cytokine or biologic \[with the exception of hematopoietic growth factors\]). Patients must have recovered from the adverse effects of prior therapy.
* Known primary or secondary malignancy of the central nervous system
* Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
* Serum creatinine \>2.0mg/dL (\>176 micromol/L)
* AST or ALT ≥3 x the upper limit of normal (ULN)
* Total bilirubin ≥1.5 x ULN (unless secondary to Gilbert's)
* Positive serology for hepatitis B (HBsAg) or hepatitis C (anti-HCV antibody)
* Known positivity for HIV
* Prior organ allograft
* Concurrent comorbid medical conditions that, in the opinion of the investigator, preclude the safe delivery of the experimental treatment
* Pregnant or nursing women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Science
state: Arkansas
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: St. Petersburg
country: United States
facility: Gulfcoast Oncology Associates
state: Florida
city: Indianapolis
country: United States
facility: Indiana Oncology/Hematology Consultants
state: Indiana
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Billings
country: United States
facility: Hematology/Oncology Centers of the Northern Rockies
state: Montana
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: Fresh Meadows
country: United States
facility: Queens Medical Associates, PC
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: NYU Medical Center
state: New York
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center/University of Rochester
state: New York
city: Cary
country: United States
facility: Raleigh Hematology/Oncology Clinic
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Oklahoma City
country: United States
facility: Cancer Care Associates/Oklahoma City
state: Oklahoma
city: Tulsa
country: United States
facility: Cancer Care Associates--Tulsa
state: Oklahoma
city: Seneca
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Abilene
country: United States
facility: Texas Cancer Center/Abilene
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates-Lake Wright Cancer Center
state: Virginia
Study officials:
References: