Status:
COMPLETED
Pomalidomide in Patients With Myeloproliferative Neoplasms in Fibrotic Stage
Lead Sponsor:
University of Ulm
Conditions:
Myeloproliferative Neoplasms
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
This is a phase II, multi-center study of pomalidomide in adult patients with PMF, SMF, and unclassifiable MPN showing at least grade 1 bone marrow fibrosis and requiring therapy. All patients will re...
Eligibility Criteria
Inclusion
- Both female and male patients meeting the mentioned inclusion and exclusion criteria will be included in this clinical trial. The risk to get PMF or SMF does not depend on a patient's gender. Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- Age ≥50 years at the time of voluntarily signing an IRB/IEC-approved informed consent
- Diagnosis of Myeloproliferative Neoplasms (MPN) either de novo myelofibrosis according to WHO criteria (PMF) \[20\], secondary myelofibrosis (post-PV MF and post-ET MF according to the IWG-MRT consensus terminology) \[21\] or unclassifiable MPN with biopsy proven myelofibrosis
- Anemia with hemoglobin level of \<10 g/dl or transfusion-dependent anemia and/or thrombocytopenia \<50 /nl or transfusion-dependent thrombocytopenia and/or neutropenia \<1.0 /nl
- Splenomegaly (\>11 cm diameter) and/or leukoerythroblastosis
- Adequate organ function, i.e. ALT and/or AST \<3 x upper limit of normal (ULN), total bilirubin \<3 x ULN, and serum creatinine \<2 mg/dl
- Subject must be willing to receive transfusion of blood products
- ECOG performance status \< 3
- Female subjects with non-childbearing potential:
- Agree to have a pregnancy test at baseline
- Male subjects:
- Agree to use condoms throughout study drug therapy, during any dose interruption and for four weeks after cessation of study therapy if their partner is of childbearing potential and has no contraception.
- Agree not to donate semen during study drug therapy and for four weeks after end of study drug therapy.
- All Subjects:
- Will be counseled about potential teratogenic risks of the study medication.
- Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
- Agree not to share study medication with another person and to return all unused study drug to the investigator
- No more than a 12-weeks-supply of study drug will be dispensed at a time.
Exclusion
- The presence of any of the following will exclude a patient from study enrollment:
- Females of childbearing potentials°, pregnant or breast feeding females
- BCR/ABL-positivity
- Diagnosis of ET (according to WHO 2008 criteria)
- Diagnosis of PV (according to WHO 2008 criteria)
- \>20% blasts in peripheral blood or bone marrow
- Known positive status for HIV, HBV or HCV
- Prior treatment with IMiDs (thalidomide, lenalidomide) or with Interferon-alpha within a 3 month time period before screening
- History of thrombosis or pulmonary embolism
- Peripheral neuropathy \>grade 1 CTC
- No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician about study participation.
- Presence of any medical/psychiatric condition or laboratory abnormalities which may limit full compliance with the study, increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study
- Drug or alcohol abuse within the last 6 months
- Patients with a "currently active" second malignancy other than nonmelanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year.
- Criteria for women of non-childbearing potential:
- A female patient or a female partner of a male patient is considered to have childbearing potential unless she meets at least one of the following criteria:
- Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year. Amenorrhoea following cancer therapy does not rule out childbearing potential
- Premature ovarian failure confirmed by a specialist gynecologist
- Previous bilateral salpingo-oophorectomy, or hysterectomy
- XY genotype, Turner syndrome, uterine agenesis
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2016
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00949364
Start Date
December 1 2009
End Date
December 14 2016
Last Update
September 25 2017
Active Locations (15)
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1
Universitätsklinikum Aachen
Aachen, Germany, 52074
2
Charité Universitätsmedizin Berlin
Berlin, Germany, 13353
3
Zentrum für Ambulante Hämatologie und Onkologie
Bonn, Germany, 53119
4
BAG Freiberg-Richter, Jacobasch, Wolf, Illmer (Gemeinschaftspraxis)
Dresden, Germany, 01307