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Deqi Pharmaceutical Celiniso Phase II clinical trial application approved in China for the treatment of myelofibrosis

 Last Update: 2021-11-05
 Source: Internet
 Author: User

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On August 23, Deqi Pharmaceutical announced that the National Medical Products Administration (NMPA) approved Celiniso (XPOVIO®) to carry out a phase II clinical trial for the treatment of patients with myelofibrosis (MF) in China
.

Myelofibrosis (MF) is a clonal myeloproliferative tumor, including primary myelofibrosis (PMF), post-polycythemia vera (PV) or post-essential thrombocythemia (ET) myelofibrosis
.

Its main characteristics are bone marrow fibrous tissue hyperplasia, extramedullary hematopoiesis, anemia, hepatosplenomegaly, constitutional symptoms, progression to leukemia and shortened survival

The trial is a phase II, randomized, open-ended, global multi-center clinical study, with the First Affiliated Hospital of Soochow University as the lead research center in China.
It is planned to be carried out in 15 research centers in China, and approximately 20 subjects will be included.
It aims to evaluate the safety and efficacy of Celinisol compared with doctor-chosen (PC) treatment in MF patients who have previously received JAK1/2 inhibitor treatment for at least 6 months
.

The subjects will be randomly divided into two groups according to a ratio of 1:1, and receive celinisol monotherapy or doctor-chosen (PC) treatment respectively

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