BRAF Inhibitor, Vemurafenib, in Patients With Relapsed or Refractory Hairy Cell Leukemia
Conditions
Hairy Cell Leukemia
Conditions: official terms
Leukemia - Leukemia, Hairy Cell
Conditions: Keywords
VEMURAFENIB, BRAF Inhibitor, 12-200, Zelboraf™
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Vemurafenib
Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to find out what effects, good and/or bad, treatment with vemurafenib (also known as Zelboraf™) has on the patient and on leukemia. Specifically, the researchers want to know how well vemurafenib eliminates leukemia from the blood.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- ≥ 18 years of age

- Histologically confirmed classical HCL with one of the following:

- Intolerance to purine analogs or considered to be poor candidates for purine analog-based therapy

- Failure to achieve any response (CR or PR) to the initial purine analog-based therapy

- Relapse ≤ 2 years of purine analog-based therapy

- ≥ 2 relapses Histologic confirmation of diagnosis will be performed at MSKCC or a participating site.

- Patients who meet the standard treatment initiation criteria, as defined by ANC ≤1.0, Hgb ≤ 10.0 or PLT ≤100K

- ECOG performance status of 0-2

- Acceptable pre-study organ function during screening as defined as: Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN, and serum creatinine ≤ 1.5x ULN

- Electrocardiogram (ECG) without evidence of clinically significant ventricular arrhythmias or ischemia as determined by the investigator and a rate-corrected QT interval (QTc, Bazett's formula) of < 480 msec.

- For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 6 months after discontinuation of vemurafenib

- For men with female partners of childbearing potential, agreement to use a latex condom and to advise their female partner to use an additional method of contraception during the study and for 6 months after discontinuation of vemurafenib

- Negative serum pregnancy test within 7 days of commencement of treatment in premenopausal women.

- Agreement not to donate blood or blood products during the study and for at least 6 months after discontinuation of vemurafenib; for male partners, agreement not to donate sperm during the study and for at least 6 months after discontinuation of vemurafenib

- Ability to understand and willingness to sign a written informed consent document.

- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

- Pregnant or breast-feeding

- Have had chemotherapy (including purine analogs, rituximab, and other investigational agents) within six weeks prior to entering the study

- Major surgery within 4 weeks prior to entering the study

- Invasive malignancy within the past 2 years prior to first study drug administration, except for adequately treated (with curative intent) basal or squamous cell carcinoma, melanoma, in situ carcinoma of the cervix, in situ ductal adenocarcinoma of the breast, in situ prostate cancer, or limited stage bladder cancer or other cancers from which the patient has been disease-free for at least 2 years

- Refractory nausea or vomiting, malabsorption, external biliary shunt, or history of any type of gastrointestinal surgery that would preclude adequate absorption of study drug

- Prior treatment with MEK or BRAF inhibitors

- Active HIV, hepatitis B and hepatitis C

- Patients with HCL variant (as defined by absence of expression of CD25 or absence of BRAF V600E mutation)
Locations
Scripps Clinic
La Jolla, California, United States
Status: Recruiting
Contact: Alan Saven, MD
Northwestern University
Evanston, Illinois, United States
Status: Recruiting
Contact: Jessica Altman, MD
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Status: Recruiting
Contact: Robert Stone, MD
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Jae Park, MD - 212-639-4048
Ohio State University
Columbus, Ohio, United States
Status: Recruiting
Contact: Michael Grever, MD
Start Date
October 2012
Completion Date
October 2016
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page