Study of Talabostat and Rituximab in Advanced Chronic Lymphocytic Leukemia (CLL)

Chronic Lymphocytic Leukemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00086203
• Other study ID #: PTH-203
• Secondary ID: FD-R-003021-01
• Status: Completed
• Phase: Phase 2
• First received: June 28, 2004
• Last updated: March 24, 2015
• Est. completion date: September 2007

Study information

• Verified date: August 2006
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Completion date provided represents the completion date of the grant per OOPD records

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

• Chronic Lymphocytic Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Talabostat mesylate (PT-100) tablets

• Rituximab

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Point Therapeutics

Country where clinical trial is conducted

United States,