Trials Sponsors Conditions Drugs Pricing

Conditions

Myeloproliferative neoplasm in accelerated phase (MPN-AP)

Outcome Measures

Primary Outcomes (1)

Phase I: physical examinations, laboratory tests, AEs, serious AEs (SAEs), ECGs, and vital signs. - DLTs (dose limiting toxicity) will be used to establish the MTD of fedratinib in combination with CC-486. The SRC will determine the RP2D and schedule based on safety data of the combination of fedratinib and CC-486. Phase II: - Best response to the combination therapy at week 24 according to the IWG-MRT and the ELN consensus report. This includes CI, PR and CR

Secondary Outcomes (1)

duration of response - Change in MF-associated symptoms measured by MFSAF - Time from the first observation of best symptom response to first documented loss of symptom response - Spleen response by palpation - Time from the first treatment dose to disease progression, relapse or death - proportion of subjects who transit to allogeneic SCT - proportion of subjects that demonstrate an anemia - Analysis of incidence of subjects with a CTCAE Grade ≥3 of nausea, diarrhea, vomiting or occurrence o

Interventions

Inrebic 100 mg hard capsulesType not reported

Onureg 200 mg film coated tabletsType not reported

Onureg 300 mg film coated tabletsType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Inrebic 100 mg hard capsules
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry record
Formulated product
Onureg 200 mg film coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record
Formulated product
Onureg 300 mg film coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Inrebic 100 mg hard capsules
Named ingredient: fedratinib
View registry record
Onureg 200 mg film coated tablets
Named ingredient: Azacitidine
View registry record
Onureg 300 mg film coated tablets
Named ingredient: Azacitidine
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Males and females at least 18 years of age at the time of signing the informed consent form - Diagnosis of MPN-AP (defined by a blast count of 10%-19% peripherally or in the bone marrow) at the time of diagnosis or at any time during the course of a known primary myelofibrosis (PMF), post– polycythemia vera (PV) myelofibrosis (MF) or post–essential thrombocythemia (ET) MF - Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of 0, 1 or 2 - Prior to Day 1 of study therapy, any treatment-related toxicities from prior therapy must have resolved to Grade 1 or pretreatment baseline of last therapy - Subject is willing and able to adhere to the study visit schedule and the protocol-specifiec procedures - Subject must understand and voluntarily sign an ICF prior to any studyrelated assessments/procedures being conducted

You may not qualify if:

Sponsors & Collaborators

Martin-Luther-Universitaet Halle-Wittenberg
Otherlead

Study Sites (8)

Universitaetsmedizin Greifswald KöR

Greifswald, 17489, Germany

William Krüger04938348622007 william.krueger@uni-greifswald.de

Rostock University Medical Center

Rostock, 18057, Germany

Christian Junghanß+493814947421 christian.junghanss@med.uni-rostock.de

Klinikum Chemnitz gGmbH

Chemnitz, 09116, Germany

Matthias Hänel+4937133344501

Central Study Contacts

Prof. Dr. med. Haifa Kathrin Al-Ali

+493455577712 haifa.al-ali@uk-halle.de

Study Design

Study Type: interventional
Phase: phase 1 2

Study Record Dates

First Submitted

November 12, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-519227-22-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 05:59:23 UTC

Documents

Placeholder Document_part_II

Subject with thiamine deficiency, defined as thiamine levels in whole blood below normal range according to institutional standard and not demonstrated to be corrected prior to start of trial treatment - Known or suspected hypersensitivity to azacitidine, mannitol, or its constituents - Subjects who are known not to tolerate a daily dose of 400 mg of XML File Identifier: jBFy3zzNZH8irDQXaSaKgq6jKT8= Page 15/30 fedratinib - The following laboratory values within 14 days prior to first dose: - Platelet count <50 x 109/L - Absolute neutrophil count (ANC) < 1.0 x 109/L - White blood count (WBC) > 100 x 109/L - Myeloblasts ≥ 20 % in peripheral blood - Serum creatinine > 2.5 x upper limit of normal (ULN) - Serum amylase or lipase > 1.5 x ULN - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x ULN - Total bilirubin > 1.5 x ULN, subject's total bilirubin between 1.5 – 3.0 x ULN are eligible if the direct bilirubin fraction is < 25 % of the total bilirubin. - Subject with prior history of Encephalopathy, including WE - Subject with signs or symptoms of Encephalopathy, including WE (eg, severe ataxia, ocular paralysis or cerebellar signs) - Subject with concomitant treatment with or use of pharmaceutical, herbal agents or food known to be strong inducers of cytochrome P450 3A4 (CYP3A4), or dual CYP2C19 and CYP3A4 inhibitors - Subject on any ongoing chemotherapy, hypomethylating agent (HMA), immunomodulatory drug therapy (eg, thalidomide, interferon-alpha), anagrelide, immunosuppressive therapy, systemic corticosteroids > 10 mg/day prednisone or equivalent. - Subject on treatment with aspirin with doses > 150 mg daily - Subject with diagnosis of active liver disease (eg, chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemochromatosis, non-alcoholic steatohepatitis) - Subject with prior malignancy other than the disease under study unless the subject has not required treatment for the malignancy for at least 3 years prior to enrollment. - Significant active cardiac disease within the previous 6 months, including: a. New York Heart Association (NYHA) class IV congestive heart failure; b. Unstable angina or angina requiring surgical or medical intervention; and/or c. Myocardial infarction - Subject with presence of any significant gastric or other disorder that would inhibit absorption of oral medication - Subject who is unable to swallow capsule - Subject is pregnant or lactating female

Study to evaluate the efficacy and safety of fedratinib in combination with CC-486 in patients suffering from myelofibrosis in acute phase.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (8)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (8)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

Locations