Acute Lymphocytic Leukemia, Leukemia
Conditions
Brief summary
We hope to learn more about the clinical efficacy of bortezomib in T-cell prolymphocytic leukemia. Patients will be selected as a possible participant in this study because they have a bone marrow disorder known as T-cell prolymphocytic leukemia (T-cell PLL) which does not tend to respond well to conventional treatment with chemotherapy.
Interventions
DRUGVelcade
IV
Sponsors
Millennium Pharmaceuticals, Inc.
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Each patient must meet all of the following inclusion criteria to be enrolled in the study: * Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. * Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. * Male subject agrees to use an acceptable method for contraception for the duration of the study. * Bilirubin: \<2.0 x Upper limit of normal (ULN)/ Alanine Transaminase (ALT): \<3.0 x ULN (\<5x ULN if hepatic compromise is present). * Eastern Cooperative Group (ECOG) 0-2. * Confirmed diagnosis of T-cell PLL according to the WHO classification. * Confirmed prior therapy to which the subject was documented to be either refractory or has relapsed since treatment and first documented response.
Exclusion criteria
Patients meeting any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the clinical activity, as represented by the overall response rate (complete response + partial response), of bortezomib in patients with relapsed or refractory T-cell prolymphocytic leukemia (PLL) | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| prolymphocytic leukemia (PLL) | 1 year |
| Evaluate time to progression in patients with T-cell prolymphocytic leukemia (PLL) | 1 year |
| Evaluate the 1-year progression free survival (PFS), and 1-year overall survival (OS) in patients with T-cell prolymphocytic leukemia (PLL) treated with Velcade compared to historical controls | 1 year |
Countries
United States
Outcome results
None listed