Status:
ACTIVE_NOT_RECRUITING
A Phase II Study of the BRAF Inhibitor, Vemurafenib, Plus Obinutuzumab in Patients With Previously Untreated Classical Hairy Cell Leukemia
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Dana-Farber Cancer Institute
Yale University
Conditions:
Hairy Cell Leukemia
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a multi-center, open label, single arm, phase II trial of the oral BRAF inhibitor, vemurafenib, plus obinutuzumab in patients with previously untreated HCL. A Simon mini-max two-stage design w...
Eligibility Criteria
Inclusion
- Patients must be \>/= 18 years of age
- Histologically confirmed classical HCL by the enrolling institution
- Has not received any prior therapy for the disease
- 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
- 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 (QT 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 with 7 days of commencement of treatment in women of childbearing potential
Exclusion
- Have had previous treatment for HCL, including purine analogs, rituximab, and other investigational agents. Previous treatment with transfusions and other supportive care such as G-CSF and erythropoietin are allowed.
- Known hypersensitivity to any of the study drugs
- Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.
- Patients with uncorrectable electrolyte abnormalities with potassium (K) \>ULN (upper limit of normal).
- Patients with any active and uncontrolled infections (such as bacterial, fungal, and new or reactivated viral infections)
- Presence of positive test results for hepatitis B virus (HBV), hepatitis B surface antigen (HBsAg) or hepatitis C (HCV) antibody.
- Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation.
- Patients with occult or prior HBV infection (defined as positive total hepatitis B core antibody \[HBcAb\] and negative HBsAg) may be included if HBV DNA is undetectable. These patients must be willing to undergo monthly DNA testing.
- Known infection with HIV or human T-cell leukemia virus 1 (HTLV-1)
- Invasive malignancy that require active systemic chemotherapy or biologics that may cause significant drug-drug interaction with either vemurafenib or obinutuzumab
- Malabsorption syndrome or other condition that precludes enteral route of administration
- Patients with HCL variant (as defined by absence of expression of CD25)
- Pregnant or lactating, or intending to become pregnant during the study
Key Trial Info
Start Date :
February 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03410875
Start Date
February 9 2018
End Date
January 1 2026
Last Update
February 11 2025
Active Locations (9)
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1
Yale University
New Haven, Connecticut, United States, 06511
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
4
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748