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Hairy Cell LeukemiaPhase 2NCT06561360

A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL)

A Phase 2 study testing Vemurafenib, Obinutuzumab and Cladribine in people with Hairy Cell Leukemia, run by Memorial Sloan Kettering Cancer Center at 10 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The researchers are doing this study to compare the safety of vemurafenib in combination with obinutuzumab to the standard of approach of cladribine in combination with rituximab. The researchers will look at which treatment causes fewer or milder side effects. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hairy Cell Leukemia
What is being tested?
Vemurafenib, Obinutuzumab and Cladribine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
10 sitesUnited States
Study dates
9 Sep 2024to 9 Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be ≥ 18 years of age
  • Histologically confirmed classical HCL by the enrolling institution
  • Presence of BRAF V600E mutation as confirmed by PCR, NGS or immunohistochemistry. If patient is known to have negative BRAF mutation, repeat testing is advisable as well as discussion with the main study principal investigator.
  • 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
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  • Acceptable pre-study organ function during screening as defined as:
  • Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), except in patients with known Gilbert's syndrome who may be enrolled if direct bilirubin ≤ 3 x 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 and cladribine, and 18 months after discontinuation of rituximab and obinutuzumab
  • 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 women of childbearing potential

Who cannot join

  • Have had previous treatment for HCL, including purine analogs, vemurafenib, rituximab, obinutuzumab, 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.
  • Patients with known long QT syndrome or uncorrectable electrolyte abnormalities
  • Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.
  • Presence of positive test results for hepatitis B virus (HBV), hepatitis B surface antigen (HBsAg) or hepatitis C (HCV) antibody
  • ° 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 and take HBV viral prophylaxis such as entecavir.
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  • Known infection with HIV or human T-cell leukemia virus 1 (HTLV-1)
  • Active uncontrolled infection, e.g. persistent bacteremia, supplemental oxygen or pressor supports, etc.
  • Live vaccination within 28 days of randomization
  • Patients with concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of the skin, in situ cervical cancer, adequately treated stage I/II cancer from which the patient is current in complete remission, or any other cancer from which the patient has been disease free for five years
  • 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

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jae Park, MD contact

646-608-3743

parkj6@mskcc.org

Mark Geyer, MD contact

646-608-3745

10 sites in 1 country

United States10 sites, 10 recruiting

  • Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)

    Basking Ridge, New Jersey, 07920

    Jae Park, MD, 646-608-3743

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

    Eric Winer, MD, 617-632-6876

    Not yet recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Michael Grever, MD, 614-293-3196

    Michael Grever, MD

    Recruiting

  • Memorial Sloan Kettering Cancer Commack - Suffolk (Limited Protocol Activities)

    Commack, New York, 11725

    Jae Park, MD, 646-608-3743

    Recruiting

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    Harrison, New York, 10604

    Jae Park, MD, 646-608-3743

    Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748

    Jae Park, MD, 646-608-3743

    Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

    Jae Park, MD, 646-608-3743

    Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

    Jae Park, MD, 646-608-3743

    Recruiting

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

    Sameer Parikh, M.B.B.S., 507-218-0772

    Not yet recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553

    Jae Park, MD, 646-608-3743

    Recruiting

Other trials in United States

About this study

Official title: A Randomized, Multi-Center, Phase II Study of Vemurafenib Plus Obinutuzumab vs. Cladribine Plus Rituximab in Patients With Previously Untreated Hairy Cell Leukemia (HCL)

The researchers are doing this study to compare the safety of vemurafenib in combination with obinutuzumab to the standard of approach of cladribine in combination with rituximab. The researchers will look at which treatment causes fewer or milder side effects. Researchers think vemurafenib and obinutuzumab (non-chemotherapy drugs) may cause fewer side effects compared with the usual approach of chemotherapy drugs. They will also compare the two approaches to see which approach is more effective at eliminating cancer cells.

Being tested
Vemurafenib, Obinutuzumab, Cladribine, Rituximab
Keywords
Vemurafenib, Obinutuzumab, Cladribine, Rituximab, 24-160
Medical subject headings
Leukemia, Hairy Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VemurafenibDrug

    Vemurafenib orally twice daily (b.i.d.) continuously in cycles of 4 weeks (28 days) for a total of 4 cycles.

  • ObinutuzumabDrug

    Obinutuzumab will be administered concomitantly with vemurafenib starting at cycle 2 of treatment in cycles of 4 weeks.

  • CladribineDrug

    Cladribine IV on days 1-5 concurrently with rituximab.

  • RituximabDrug

    Rituximab on days 1-5 concurrently with rituximab.

Study groups in NCT06561360
Study groupRoleWhat they receive
Vemurafenib plus ObinutuzumabExperimentalPatients assigned to the study arm will receive vemurafenib orally twice daily (b.i.d.) continuously in cycles of 4 weeks (28 days) for a total of 4 cycles. Obinutuzumab will be administered concomitantly with vemurafenib starting at cycle 2 of treatment in cycles of 4 weeks. Obinutuzumab infusions will be administered on days 1, 8 and 15 during the cycle 2 and every 4 weeks during the cycle 3 and 4 of treatment.
Receives: Drug: Vemurafenib; Drug: Obinutuzumab
Standard treatment of Cladribine plus RituximabActive comparatorPatients assigned to the SOC arm will receive cladribine IV on days 1-5 concurrently with rituximab IV per week for 8 times, i.e., weekly x8 from day 1.
Receives: Drug: Cladribine; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidences of ≥ grade 3 treatment-related toxicities

    per CTCAE v5.0 within first 6 months from the start of the treatment to account delayed toxicities of the treatments

    Measured: within 6 months of treatment

Secondary outcomes (2)

  1. complete remission

    Response will be determined by the Consensus Resolution response criteria.

    Complete response (CR)

    • A morphological absence of hairy cells in the blood and bone marrow
    • A normalization of any organomegaly and cytopenias

    Measured: 2 years

  2. partial response

    Partial response (PR)

    °A normalization of cytopenias

    °≥50% reduction in organomegaly and bone marrow hairy cells.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2024
  2. Study start9 Sep 2024
  3. Primary completion9 Sep 2027 (estimated)
  4. Study completion9 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized phase II multi-center, open-label, study of vemurafenib plus obinutuzumab (experimental arm) vs. cladribine plus rituximab (standard of care arm) in patients with previously untreated HCL.
Masking
None (open label)
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06561360
Sponsor's protocol ID
24-160
Status last verified
Sep 2026
First submitted
13 Aug 2024
Last updated
9 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vemurafenib, Obinutuzumab and Cladribine in people with Hairy Cell Leukemia, run by Memorial Sloan Kettering Cancer Center at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jae Park, MD (646-608-3743, parkj6@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidences of ≥ grade 3 treatment-related toxicities (time frame: within 6 months of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06561360.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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