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New combo therapy shows promise for rare leukemia patients

NCT ID NCT03410875

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

30 people

The number who actually took part.

Started

Feb 2018

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021, United States

  • Memorial Sloan Kettering Cancer Center @ Commack (Limited Protocol Activities)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604, United States

  • Memorial Sloan Kettering at Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Yale University

    New Haven, Connecticut, 06511, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.