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BRAF Inhibitor, Vemurafenib, in Patients With Relapsed or Refractory Hairy Cell Leukemia

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hairy Cell Leukemia

Intervention: Vemurafenib (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Jae H. Park, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

Overall contact:
Jae H Park, MD, Phone: 212 639-4048

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.

Clinical Details

Official title: A Phase II Study of the BRAF Inhibitor, Vemurafenib, in Patients With Relapsed or Refractory Hairy Cell Leukemia

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: efficacy of vemurafenib

Secondary outcome:

Toxicity (safety and tolerability)

To assess the pharmacodynamics

evaluate biomarkers

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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 and Contacts

Jae H Park, MD, Phone: 212 639-4048

Scripps Clinic, La Jolla, California 92037, United States; Recruiting
Alan Saven, MD
Alan Saven, MD, Principal Investigator

Northwestern University, Evanston, Illinois 60208, United States; Recruiting
Jessica Altman, MD
Jessica Altman, MD, Principal Investigator

Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States; Recruiting
Robert Stone, MD
Robert Stone, MD, Principal Investigator

Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States; Recruiting
Jae Park, MD, Phone: 212-639-4048
Martin S. Tallman, MD, Phone: 212-639-3842
Jae Park, MD, Principal Investigator

Ohio State University, Columbus, Ohio 43210, United States; Recruiting
Michael Grever, MD
Michael Grever, MD, Principal Investigator

Additional Information

Memorial Sloan Kettering Cancer Center

Starting date: October 2012
Last updated: May 8, 2015

Page last updated: August 20, 2015

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