Phase II Study of Bortezomib (VELCADE) for the Treatment of Relapsed or Refractory T-cell Prolymphocytic Leukemia
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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Velcade
Phase: Phase 2
Ages Eligible For Study:
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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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.