A phase II trial in patients with myelofibrosis (primary, post-ET or post PV-MF) treated with the selective JAK2 inhibitor Pacritinib before reduced-intensity conditioning allogeneic stem cell transplantation - HOVON 134 MF

HOVON Foundation0 sites70 target enrollmentMarch 30, 2018

ConditionsPrimary myelofibrosisPolycythemia veraEssential thrombocytosis MedDRA version: 20.0Level: LLTClassification code 10074689Term: Post polycythemia vera myelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10074690Term: Post essential thrombocythemia myelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA 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]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Primary myelofibrosisPolycythemia veraEssential thrombocytosis
Sponsor: HOVON Foundation
Enrollment: 70
Status: Active, Not Recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 30, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

HOVON Foundation

Eligibility Criteria

Inclusion Criteria

•\-Patients with a confirmed diagnosis of post\-ET, post\-PV or primary myelofibrosis (Appendix A)
•\-Intermediate\-2 or high\-risk according to DIPSS plus (Appendix F)
•\-Age 18\-70 years inclusive
•\-WHO performance status 0\-2 (Appendix C)
•\-All men and women of childbearing potential must agree to use adequate contraception during the study
•\-Written informed consent
•\-Patient is capable of giving informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

•\- Previous treatment with JAK2 inhibitors within 2 weeks of study inclusion. Patients who have been treated with pacritinib as their previous JAK2 inhibitor treatment cannot participate in this study.
•\- Any GI or metabolic condition (e.g. inflammatory or chronic functional bowel disorder such as Crohn’s Disease, Inflammatory Bowel Disease, chronic diarrhea or constipation) that could interfere with absorption of oral medication
•\- Left ventricular cardiac ejection fraction of \= 45% by echocardiogram or multigated acquisition (MUGA) scan
•\- Impaired liver and renal function, defined by liver transaminases (aspartate aminotransferase \[AST]/serum glutamic oxaloacetic transaminase \[SGOT] and alanine aminotransferase \[ALT]/serum glutamic pyruvic transaminase \[SGPT]), \>3 × the upper limit of normal (ULN) (AST/ALT \>5 × ULN if transaminase elevation is related to MF), direct bilirubin \>4× ULN, and creatinine clearance ? 40 ml/min.
•\-Experimental treatment within four weeks before inclusion for PMF, Post\-PV, or Post\-ET MF
•\-Severe pulmonary dysfunction (CTCAE grade III\-IV, see appendix D)
•\- Treatment with a potent strong CYP3A4 inhibitor or a strong cytochrome P450 (CYP450\) inducer within the last 2 weeks
•\- Treatment with anticoagulation or antiplatelet agents, except for aspirin dosages of \=100 mg per day, within the last 2 weeks
•\- New York Heart Association Class II, III, or IV congestive heart failure
•\- QTc prolongation \>450 ms as assessed by ECG and corrected by Federicia method or other factors that increase the risk for QT interval prolongation (e.g., heart failure, hypokalemia \[defined as serum potassium \<3\.0 mEq/L that is persistent and refractory to correction], family history of long QT interval syndrome, or concomitant use of medications that may prolong QT interval)