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

Point Therapeutics

Status and phase

Completed

Phase 2

Conditions

Chronic Lymphocytic Leukemia

Treatments

Drug: Rituximab

Drug: Talabostat mesylate (PT-100) tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT00086203

FD-R-003021-01

PTH-203

Details and patient eligibility

About

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.

Full description

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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