Kombinationsbehandling med Interferon og JAK1-2 Hæmmer i behandlingen af Ph-Negativ Myeloprolifertiv Cancer

Phase 1

• Conditions: MedDRA version: 18.1Level: LLTClassification code 10028538Term: Myelofibrosis with myelometaplasiaSystem Organ Class: 100000004864; MedDRA version: 18.1Level: LLTClassification code 10036061Term: Polycythemia veraSystem Organ Class: 100000004864; MedDRA version: 18.1Level: LLTClassification code 10053134Term: OsteomyelofibrosisSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2013-003295-12-DK
• Lead Sponsor: Roskilde University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-28
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

3.1 Inclusion Criteria
1. Male or female patients> 18 years.
2. Patients with early prefibrotic myelofibrosis /post-ET myelofibrosis , PV, Post-PV myelofibrosis or hyperproliferative PMF according to WHO classification.
3. Active disease defined by one or more of the following criteria, at some time before study enrollment and accordingly not necessarily at the time or weeks before enrollment :
a) Need for venesection (hematocrit> 0.42 in females and > 0.45 in males)
b) White blood cell counts > 10 MIA/L in the absence of infection / inflammation.
c) Platelet count> 400 MIA/L in the absence infection / inflammation.
d) Hypermetabolic symptoms such as weight loss (> 10% within 6 months), night sweats and subfebrilia (temperature> 38 º C for more than 2 weeks without signs of infection)
e) Pruritus
f) Symptomatic splenomegaly
g) Presence of previous thrombosis.

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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

3.2 Exclusion Criteria
1. Childbearing potential patients without a negative pregnancy test prior to initiation of study drug and / or non-acceptance of the use of effective contraceptive methods *
2. Other active malignancy within the past 5 years (except basal cell carcinoma of the skin).
3. ECOG function scores> / = 3
4. Serum creatinine more than 2 x ULN
5. Total serum bilirubin greater than 1.5 x ULN
6. Plasma ALT more than 3 x ULN
7. Former psychiatric disorder (depression diagnosed by a psychiatrist)
8. Uncontrolled metabolic disease.
9. Severe heart disease (heart failure NYHA class 3-4).
10. Severe myelosuppression. (leucocyte count<1.5 Mill/L, Platelet count<100)
11. Chronic hepatitis with decompensated cirrhosis.
12. Chronic hepatitis in patients who have been or recently (within 6 months) has been treated with immunosuppressive drugs with the exception of corticosteroid treatment.
13. Epilepsy and / or other serious CNS disorders.
14. Known hypersensitivity to recombinant interferon (Pegasys or PegIntron) and JAKAVI, or to one or more of these preparations .
* Spiral, birth control pills, implants, transdermal patch, vaginal ring or transdermal injection.
Sterile / infertile subjects are exempt from the use of contraception. In order to be considered sterile or infertile, one must generally be surgically sterilized (vasectomy, bilateral tubectomy, hysterectomy or ovariectomy) or be postmenopausal, defined as absent menstruation for at least 12 months before study enrollment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified