A randomized, open-label, phase 3 study studying the efficacy and safety of navitoclax in combination with ruxolitinib versus best available therapy in patients relapsed myelofibrosis
- Conditions
- MyelofibrosisMedDRA version: 20.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-000557-27-IT
- Lead Sponsor
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 330
• Subject = 18 years of age.
• Subject must be able to complete the MFSAF v4.0 on at least 4 out of 7
days prior to randomisation.
- Subject has at least 2 symptoms with a score = 3 or a total score of =
12, as measured by the MFSAF v4.0.
• Subject with a documented diagnosis of primary MF, post polycythemia
vera (PPV)-MF, or post essential thrombocythemia (PET)–MF as defined
by the World Health Organization classification.
• Subject classified as intermediate-2 or high-risk MF, as defined by the
Dynamic International Prognostic Scoring System (DIPSS).
XML File Identifier: SrChOEVV+uqliGuLipfecZFKPGA=
Page 34/45
• Subject must have received prior treatment with a single JAK2
inhibitor and meet one of the following criteria (in addition to the
minimum splenomegaly and symptom burden also required for
eligibility):
- Prior treatment with JAK2 inhibitor for = 24 weeks that was stopped
due to lack of spleen response, or loss of spleen response or symptom
control after a previous response, or was continued despite
relapsed/refractory status.
- Prior treatment with JAK2 inhibitor for < 24 weeks with documented
disease progression while on JAK2 inhibitor therapy.
• Subject has splenomegaly defined as spleen palpation measurement =
5 cm below costal margin or spleen volume = 450 cm^3 as assessed
centrally by MRI or CT scan.
• Subject has a baseline platelet count = 100 × 10^9 /L.
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 285
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
• Subject must not have received prior treatment with a BH3-mimetic compound or prior use of >1 JAK2 inhibitor.
• Subject must not receive medication that interferes with coagulation or platelet function within 3 days prior to the first dose of study drug or during the study treatment period.
• Subject must not receive anticancer therapy including chemotherapy, radiation therapy, hormonal therapy within 30 days prior to first dose of study drug, and during the study treatment period (other than any overlapping therapy as part of the selected BAT)
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