New combo therapy shows promise for rare leukemia patients
NCT ID NCT03410875
First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times
Summary
This study tests a combination of two drugs, vemurafenib (a pill) and obinutuzumab (an infusion), in 30 people with previously untreated hairy cell leukemia. The goal is to see how many patients achieve a complete response, meaning no signs of cancer after treatment. Participants take vemurafenib for 4 months and receive obinutuzumab infusions starting in the second month. The study is currently active but no longer recruiting new participants.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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30 people
The number who actually took part.
- Started
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Feb 2018
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
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Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
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Memorial Sloan Kettering Cancer Center @ Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
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Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, 07920, United States
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Yale University
New Haven, Connecticut, 06511, United States
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