ACTIVE_NOT_RECRUITING

Low Dose Vemurafenib and Rituximab in Hairy Cell Leukemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The current standard-of-care for Hairy Cell Leukemia involves chemotherapy, with agents such as cladribine or pentostatin. Chemotherapy is associated with infection, low blood counts and predisposition to future cancers. This study tests a new yet previously validated drug combination for the treatment of hairy cell leukemia. The treatment involves 8 weeks of treatment with an oral drug called vemurafenib and 8 doses of an intravenous medication called rituximab. The goal of this study is to see whether this treatment is better tolerated and more effective than the currently used treatment in this disease. In addition, this study uses a lower dose of vemurafenib than previous studies have used, with the goal of minimizing side effects from this medication.

Official Title

A Single Arm Phase II Pilot Study of Low Dose Vemurafenib Plus Rituximab in the Front-line and Relapsed/Refractory Treatment of Hairy Cell Leukemia

Quick Facts

Study Start:2022-03-02

Study Completion:2026-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05388123

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* ≥ 18 years of age * Histologically confirmed HCL that are BRAF V600E positive by IHC or NGS * Patient's must meet the standard treatment initiation criteria, as defined by ANC ≤1.0, Hgb ≤ 10.0 or PLT ≤100K * Patients can either have (1) not received any prior therapy for the disease or have had (2) failure to achieve any response to the initial purine analog-based therapy or (3) subsequent relapse after any prior therapy. * ECOG performance status of 0-2 * Acceptable pre-study organ function during screening not exacerbated by Hairy Cell Leukemia. General thresholds should be a 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 * For women of childbearing potential, agreement to use acceptable methods of contraception * For men with female partners of childbearing potential, agreement to use barrier contraception * Negative serum pregnancy test within 7 days of commencement of treatment in premenopausal women. * Ability to understand and willingness to sign a written informed consent document. * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.	* Pregnant or breast-feeding or intending to become pregnant during the study * Have had chemotherapy (including purine analogs), rituximab, and other investigational agents within six weeks prior to entering the study. The patients cannot have received BRAF inhibitor therapy within 6 months of entering the study. * Major surgery within 4 weeks prior to entering the study * Invasive malignancy within the past 2 years prior to first study drug administration, except for adequately treated (with curative intent) basal or squamous cell carcinoma, melanoma, in situ carcinoma of the cervix, in situ ductal adenocarcinoma of the breast, in situ prostate cancer, or limited stage bladder cancer or other cancers from which the patient has been disease-free for at least 2 years * Active HIV, hepatitis B and hepatitis C or any clinically significant history of liver disease. Hepatitis B prior infection is not a contraindication though will require therapy. * Known hypersensitivity to any of the study drugs * Patients with HCL that are BRAF V600E mutation negative

Inclusion Criteria

Exclusion Criteria

* ≥ 18 years of age
* Histologically confirmed HCL that are BRAF V600E positive by IHC or NGS
* Patient's must meet the standard treatment initiation criteria, as defined by ANC ≤1.0, Hgb ≤ 10.0 or PLT ≤100K
* Patients can either have (1) not received any prior therapy for the disease or have had (2) failure to achieve any response to the initial purine analog-based therapy or (3) subsequent relapse after any prior therapy.
* ECOG performance status of 0-2
* Acceptable pre-study organ function during screening not exacerbated by Hairy Cell Leukemia. General thresholds should be a 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
* For women of childbearing potential, agreement to use acceptable methods of contraception
* For men with female partners of childbearing potential, agreement to use barrier contraception
* Negative serum pregnancy test within 7 days of commencement of treatment in premenopausal women.
* Ability to understand and willingness to sign a written informed consent document.
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

* Pregnant or breast-feeding or intending to become pregnant during the study
* Have had chemotherapy (including purine analogs), rituximab, and other investigational agents within six weeks prior to entering the study. The patients cannot have received BRAF inhibitor therapy within 6 months of entering the study.
* Major surgery within 4 weeks prior to entering the study
* Invasive malignancy within the past 2 years prior to first study drug administration, except for adequately treated (with curative intent) basal or squamous cell carcinoma, melanoma, in situ carcinoma of the cervix, in situ ductal adenocarcinoma of the breast, in situ prostate cancer, or limited stage bladder cancer or other cancers from which the patient has been disease-free for at least 2 years
* Active HIV, hepatitis B and hepatitis C or any clinically significant history of liver disease. Hepatitis B prior infection is not a contraindication though will require therapy.
* Known hypersensitivity to any of the study drugs
* Patients with HCL that are BRAF V600E mutation negative

Contacts and Locations

Principal Investigator

Alan Saven, MD

PRINCIPAL_INVESTIGATOR

Scripps Clinic

Study Locations (Sites)

Scripps Cancer Center

La Jolla, California, 92037

United States

Collaborators and Investigators

Sponsor: Scripps Health

Alan Saven, MD, PRINCIPAL_INVESTIGATOR, Scripps Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-02

Study Completion Date2026-12-01

Study Record Updates

Study Start Date2022-03-02

Study Completion Date2026-12-01

Terms related to this study

Additional Relevant MeSH Terms

Hairy Cell Leukemia