NCT02370329终止2 期
Phase II Study of P1101 in Early Myelofibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Best Overall Response (Complete Remission, Partial Remission, or Clinical Improvement) as Determined by International Working Group Criteria
研究概览
简要总结
This pilot phase II trial studies P1101 (polyethyleneglycol [PEG]-proline-interferon alpha-2b) in treating patients with myelofibrosis. PEG-proline-interferon alpha-2b is a substance that can improve the body's natural response and may slow the growth of myelofibrosis.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate for clinical response (complete remission [CR], partial remission [PR], or clinical improvement [CI]) as defined by International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria in a cohort of intermediate-2/high risk myelofibrosis (MF) patients. Response in a second cohort of early stage MF patients will also be described.
SECONDARY OBJECTIVES:
I. To evaluate the adverse event profile of P1101 in patients with myelofibrosis by cohort (early vs intermediate-2/high risk).
II. To evaluate the tolerability of P1101 in patients with myelofibrosis by cohort (early vs intermediate-2/high risk).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evaluable myelofibrosis by IWG-MRT criteria including one or more of the following:
- •Spleen >= 5 cm below the left costal margin
- •MPN-SAF total symptom score (TSS) > 10 at baseline
- •Hemoglobin < 10 g/dL
- •Confirmed diagnosis of myelofibrosis (primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia or polycythemia vera) by World Health Organization (WHO) diagnostic criteria (3 major and 2 minor criteria: major criteria: megakaryocyte proliferation and atypia with either reticulin and/or collagen fibrosis, not meeting criteria for chronic myelogenous leukemia [CML], polycythemia vera [PV], myelodysplastic syndrome [MDS], or other myeloid neoplasm, JAK2V617F or other clonal marker or no evidence of reactive marrow fibrosis; minor criteria: leukoerythroblastosis, increased lactate dehydrogenase [LDH], anemia, palpable splenomegaly)
- •For cohort 1: early stage MF (low or intermediate 1 stage as defined by Dynamic International Prognostic Scoring System [DIPSS]) without currently available treatment options
- •For cohort 2: intermediate-2 or high risk MF patients as defined by DIPSS either not eligible for ruxolitinib or having failed under ruxolitinib
- •No prior treatment for myelofibrosis (for cohort 1 only)
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- •Platelet count >= 100,000/mm^3 (obtained =< 14 days prior to registration)
- •Absolute neutrophil count (ANC) >= 1000/mm^3 (obtained =< 14 days prior to registration)
- •Aspartate transaminase (AST) =< 2.5 x upper limit of normal (ULN) (obtained =< 14 days prior to registration)
- •Alanine aminotransferase (ALT) =< 2.5 x ULN (obtained =< 14 days prior to registration)
- •Calculated creatinine clearance must be >= 50 ml/min using the Cockcroft-Gault formula (obtained =< 14 days prior to registration)
- •Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Provide informed written consent
- •Willing to return to enrolling institution for follow-up
- •Willing to provide blood samples for correlative research purposes
排除标准
- •Patients who have had chemotherapy or radiation =< 2 weeks of registration
- •For cohort 1 only: patients with evidence of intermediate 2 or high risk disease (according to DIPSS)
- •For cohort 1 only: patients with a bone marrow biopsy with < 15% cellularity, evidence of collagen fibrosis, osteosclerosis, or blasts > 10% in peripheral blood or marrow (demonstrating advanced disease)
- •Patients who have received a prior stem cell transplant
- •Patients who have received radiation to the spleen within 3 months prior to registration
- •Patients with intolerance to compounds similar to pegylated interferon alpha-2b
- •Patients with evidence of >= grade 2 peripheral sensory neuropathy
- •Any of the following:
- •Pregnant women
- •Nursing women
- •Men or women of childbearing potential who are unwilling to employ adequate contraception
- •Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- •Immunocompromised patients or patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
- •Uncontrolled simultaneous illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, history of depression, or psychiatric illness/social situations that would limit compliance with study requirements
- •Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- •History of myocardial infarction =< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- •History of significant or major funduscopic findings including, but not limited to, retinal exudates, hemorrhage, detachment, neovascularization, papilledema, optic atrophy, micro-aneurysm or macular changes
- •Other active malignancy at time of registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix
研究组 & 干预措施
Treatment (PEG-proline-interferon alpha-2b)
Experimental
Patients receive PEG-proline-interferon alpha-2b SC on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (PEG-proline-interferon alpha-2b)
Experimental
Patients receive PEG-proline-interferon alpha-2b SC on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Treatment (PEG-proline-interferon alpha-2b)
Experimental
Patients receive PEG-proline-interferon alpha-2b SC on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Ropeginterferon Alfa-2B (Biological)
结局指标
主要结局
Best Overall Response (Complete Remission, Partial Remission, or Clinical Improvement) as Determined by International Working Group Criteria
时间窗: Up to 3 years
Patients will be assessed for response according to the Revised International Working Group for Myeloproliferative Neoplasms Research and Treatment criteria.
次要结局
- Progression-free Survival Time(Up to 3 years)
- Number of Patients Experiencing a Grade 3+ Adverse Event, as Measured by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4)(Up to 3 years)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
2 期
PAT-1251 in Treating Patients With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocytosis MyelofibrosisMyelofibrosis Transformation in Essential ThrombocythemiaPolycythemia Vera, Post-Polycythemic Myelofibrosis PhasePrimary MyelofibrosisNCT04054245M.D. Anderson Cancer Center
已完成
2 期
Tipifarnib in Treating Patients With Myelofibrosis and Myeloid MetaplasiaEssential ThrombocythemiaPolycythemia VeraPrimary MyelofibrosisNCT00047190National Cancer Institute (NCI)35
终止
2 期
Nivolumab in Treating Patients With Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, or Post-Polycythemia Vera MyelofibrosisHepatomegalyMyelofibrosis Transformation in Essential ThrombocythemiaPolycythemia Vera, Post-Polycythemic Myelofibrosis PhaseSplenomegalyPrimary MyelofibrosisNCT02421354M.D. Anderson Cancer Center8
进行中（未招募）
1 期
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 transplantatioPrimary myelofibrosisPolycythemia veraEssential thrombocytosisMedDRA version: 21.0Level: LLTClassification code 10074689Term: Post polycythemia vera myelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: 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)EUCTR2015-000195-98-NLHOVON Foundation70
进行中（未招募）
1 期
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 transplantatioPrimary myelofibrosisPolycythemia veraEssential thrombocytosisMedDRA 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)EUCTR2015-000195-98-BEHOVON Foundation70