- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01162031
Phase II Study of VELCADE for Relapsed or Refractory T-cell Prolymphocytic Leukemia
May 16, 2018 updated by: Stanford University
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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 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 enrollment.
- 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 medically relevant.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome 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)
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
prolymphocytic leukemia (PLL)
Time Frame: 1 year
|
1 year
|
Evaluate time to progression in patients with T-cell prolymphocytic leukemia (PLL)
Time Frame: 1 year
|
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
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
July 12, 2010
First Submitted That Met QC Criteria
July 13, 2010
First Posted (Estimate)
July 14, 2010
Study Record Updates
Last Update Posted (Actual)
May 21, 2018
Last Update Submitted That Met QC Criteria
May 16, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, Lymphoid
- Leukemia, T-Cell
- Leukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Prolymphocytic
- Leukemia, Prolymphocytic, T-Cell
- Antineoplastic Agents
- Bortezomib
Other Study ID Numbers
- IRB-15361
- X05278 (Other Identifier: Millennium Pharmaceuticals)
- SU-09232008-1304 (Other Identifier: Stanford University)
- HEMTPLL0001 (Other Identifier: OnCore)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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