VEMURAFENIB + RITUXIMAB (VR) AS A CHEMOTHERAPY-FREE ALTERNATIVE TO CLADRIBINE + RITUXIMAB (CDAR) IN FRONT-LINE HAIRY CELL LEUKEMIA (HCL): A PHASE-2 RANDOMIZED MULTICENTER TRIA
- Conditions
- Previously untreated patients with diagnosis of HCLMedDRA version: 21.0Level: PTClassification code 10019053Term: Hairy cell leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-001864-12-IT
- Lead Sponsor
- DIPARTIMENTO DI MEDICINA, UNIVERSITà DI PERUGIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 120
Any incoming patient with untreated HCL must be screened, and must be enrolled in the study if satisfying all of the following general eligibility criteria no. 1-8 (while not meeting any exclusion criteria – see next section):
1.Previously untreated patients with centrally reviewed diagnosis of HCL
2.Need of treatment, i.e. at least one of the following: neuthrophils <1x109 per liter, hemoglobin <10 g per deciliter, platelets <100x109 per liter, bulky/symptomatic splenomegaly, clinically relevant infiltration of other organs (e.g., lymphadenopathy), disease-related opportunistic infections or autoimmune disorders.
3.ECOG Performance Status of 0-2.
4.Male or female HCL patients =18 years of age.
5.Negative serum pregnancy test within 14 days prior to commencement of dosing in premenopausal women.
6.Women of childbearing potential must use effective contraception during treatment and for at least 6 months after treatment.
7.No medical, psychological, familial, sociological or geographical condition which may hamper compliance with the study protocol and follow-up schedule, or interfere with the interpretation of study results or would anyway make the patient inappropriate for enrollment in this study.
8.Signed informed consent (prior to performing any study-related procedures).
After enrollment in the study, patients must also fulfill the following additional specific inclusion criteria for randomization to CDAR or VR:
9.BRAF-V600E mutation centrally confirmed.
10.No nausea, vomiting, malabsorption, external biliary shunt, significant bowel resection, or neurological disorder that would preclude adequate absorption. Patients must be able to swallow tablets.
11.No (suspected or documented) active uncontrolled serious infection, as defined by the presence of: i) febrile neutropenia (a single temperature of >38.3°C or a sustained temperature of =38°C for >1 hour) in a neutropenic patient (<1000 neutrophils x 109/L without G-CSF support), which has not resolved within =7 days from its onset despite anti-microbial therapy; and/or ii) a radiologically or clinically documented focus of infection (e.g., abscess, pneumonia, cellulitis, etc.) that has not been cleared by medical or surgical therapy.
12.Receipt of Evusheld prophylaxis against Covid19.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
1.Concurrent administration of other any anti-cancer therapies. Prior splenectomy for diagnosis and/or therapy of HCL is not allowed.
2. Pregnancy or lactation.
3. Other active advanced cancer with projected life expectancy <1 year.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method