Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06561360 | RECRUITING | Hairy Cell Leukemia

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

Memorial Sloan Kettering Cancer Center

Brief 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. 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.

Condition or disease

Hairy Cell Leukemia

Intervention/treatment

Vemurafenib

Obinutuzumab

Cladribine

Rituximab

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 86 participants
Masking : NONE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2024-09-09
Estimated Primary Completion Date : 2027-09-09
Estimated Study Completion Date : 2027-09-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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
  • * 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 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
    Exclusion Criteria
    • * 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.
    • * 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
A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People with Hairy Cell Leukemia (HCL)

Location Details

NCT06561360

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02115

NOT YET RECRUITING

United States, Minnesota

Mayo Clinic Cancer Center

Rochester, Minnesota, United States, 55905

RECRUITING

United States, New Jersey

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

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

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States, 11553

NOT YET RECRUITING

United States, Ohio

Ohio State University

Columbus, Ohio, United States, 43210