VEMURAFENIB + RITUXIMAB (VR) AS A CHEMOTHERAPY-FREE ALTERNATIVE TO CLADRIBINE + RITUXIMAB (CDAR) IN FRONT-LINE HAIRY CELL LEUKEMIA (HCL): A PHASE-2 RANDOMIZED MULTICENTER TRIAL - HCL-PG05

DIPARTIMENTO DI MEDICINA, UNIVERSITà DI PERUGIA0 个研究点目标入组 120 人开始时间: 2022年8月25日最近更新: 2023年8月28日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 120

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•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

排除标准

•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.

研究者

发起方

DIPARTIMENTO DI MEDICINA, UNIVERSITà DI PERUGIA

相似试验

进行中（未招募）

1 期

STEP-WISE COMBINATION OF OBINUTUZUMAB, VEMURAFENIB AND COBIMETINIB IN PATIENTS WITH HAIRY CELL LEUKEMIA (HCL) PREVIOUSLY TREATED WITH PURINE ANALOGS OR UNFIT FOR CHEMOTHERAPY: A PHASE-2, SINGLE-ARMS, ITALIAN, MULTICENTER STUDY (HCL-PG04)HCL patients carrying the BRAF-V600E mutationMedDRA version: 21.0Level: LLTClassification code 10019055Term: Hairy cell leukemiaSystem Organ Class: 100000004864

EUCTR2017-001836-20-ITPROF.BRUNANGELO FALINI, DR.ENRICO TIACCI. DIPARTIMENTO DI MEDICINA, UNIVERSITA' DI PERUGIA42

进行中（未招募）

1 期

EQUENTIAL THERAPY WITH VEMURAFENIB AND ELECTROCHEMOTHERAPY FOR IN-TRANSIT MELANOMA METASTASES

EUCTR2015-004960-12-ITINTERGRUPPO MELANOMA ITALIANO53

招募中

2 期

BRENTUXIMAB VEDOTIN ASSOCIATED WITH CHEMOTHERAPY IN UNTREATED PATIENTS WITH STAGE I/II UNFAVOURABLE HODGKIN LYMPHOMA - A RANDOMIZED PHASE II LYSA-FIL-EORTC INTERGROUP STUDY BREACHCHEMOTHERAPYUNFAVOURABLE HODGKIN LYMPHOMA10025319

NL-OMON55642YSARC14

进行中（未招募）

1 期

BRENTUXIMAB VEDOTIN ASSOCIATED WITH CHEMOTHERAPY IN UNTREATED PATIENTS WITH STAGE I/II UNFAVOURABLE HODGKIN LYMPHOMA - A RANDOMIZED STUDYntreated patients with histologically confirmed CD30+ classical Hodgkin lymphoma (stage I/II), aged > or = 18 and < or = 60 years old, with at least one unfavourable clinical pronostic factorMedDRA version: 20.0Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2013-000182-37-DKYSARC170

进行中（未招募）

1 期

EUCTR2013-000182-37-BEYSARC170