Phase II Study of Bortezomib (VELCADE) for the Treatment of Relapsed or Refractory T-cell Prolymphocytic Leukemia
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not part of normal medical care, with the understanding that consent may be withdrawn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
- 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 exclusion criteria are not to be
enrolled in the study.
- Patient has a platelet count of <30' 10 9/L within 14 days before enrollment.
- Patient has an absolute neutrophil count of <1.0 ´ 10 9/L within 14 days before
- Patient has ³Grade 2 peripheral neuropathy within 14 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has New York Heart
Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled
angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence
of acute ischemia or active conduction system abnormalities. Prior to study entry,
any ECG abnormality at Screening has to be documented by the investigator as not
- Patient has hypersensitivity to bortezomib, boron or mannitol.
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not
pregnant must be established by a negative serum b-human chorionic gonadotropin
(beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not
required for post-menopausal or surgically sterilized women.
- Patient has received other investigational drugs with 14 days before enrollment.
- Diagnosed or treated for another malignancy within 3 years of enrollment, with the
exception of complete resection of basal cell carcinoma or squamous cell carcinoma of
the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
- Patients with uncontrolled intercurrent illness, active or uncontrolled infections,
or a fever >38.5c on the day of scheduled dosing.
- Patients with serious illnesses, medical conditions, or other medical history,
including laboratory results, which, in the investigator's opinion, would be likely
to interfere with a patient's participation in the study, or with the interpretation
of the results.
- Any condition (e.g., known or suspected poor compliance, psychological instability,
geographical location, etc) that, in the judgment of the investigator, may affect the
patient's ability to sign the informed consent and undergo study procedures.
- Any condition that will put the patient at undue risk or discomfort as a result of
adherence to study procedures.