NCT00445900已完成2 期
Phase II Study of the Combination of Low-Dose Thalidomide, Prednisone, and Oral Cyclophosphamide ("TPC") in the Therapy of Myelofibrosis With Myeloid Metaplasia (MMM)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 22
- 主要终点
- Confirmed response, defined as a complete or partial response in ≥ 1 of 3 response categories (i.e., anemia, thrombocytopenia, or splenomegaly or hepatomegaly)
研究概览
简要总结
RATIONALE: Giving thalidomide together with prednisone and cyclophosphamide may lessen symptoms caused by myelofibrosis and myeloid metaplasia.
PURPOSE: This phase II trial is studying the side effects and how well giving thalidomide together with prednisone and cyclophosphamide works in treating patients with myelofibrosis and myeloid metaplasia.
详细描述
OBJECTIVES:
Primary
- Determine the benefit of thalidomide, prednisone, and cyclophosphamide in alleviating disease-associated anemia, thrombocytopenia, and/or splenomegaly in patients with myelofibrosis with myeloid metaplasia (MMM).
- Determine the benefit of this regimen in palliating four hypercatabolic constitutional symptoms (i.e., weight loss, fatigue, drenching night sweats, and unexplained fevers) in these patients.
- Determine the toxicity profile of this regimen in these patients.
Secondary
- Determine the effect of this regimen on leukocyte count.
- Determine the effect of this regimen on bone marrow histology, including microvessel density and reticulin fibrosis.
- Determine the effect of this regimen on intramedullary and urinary markers of angiogenesis.
- Determine the effect of this regimen on circulating myeloid progenitor cells by quantifying CD34+ cells.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed myelofibrosis with myeloid metaplasia (MMM) of any of the following subtypes:
- •Agnogenic myeloid metaplasia
- •Post-polycythemic myeloid metaplasia
- •Post-thrombocythemic myeloid metaplasia
- •Must have 1 of the following MMM-related conditions:
- •Anemia, defined as hemoglobin < 10 g/dL
- •Iron deficiency must be excluded as cause
- •Thrombocytopenia, defined as platelet count < 100,000/mm³
- •Palpable hepatomegaly or splenomegaly
- •No evidence of myelofibrosis-associated conditions in the bone marrow, including any of the following:
- •Metastatic carcinoma
- •Myelodysplasia
- •Hairy cell leukemia
- •Mast cell disease
- •Acute leukemia (including M7 type)
- •Acute myelofibrosis
- •No chromosomal translocation t(9:22) or bcr-abl as determined by bone marrow chromosome analysis or peripheral blood fluorescent in situ hybridization (FISH) analysis
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-3
- •Absolute neutrophil count ≥ 750/mm³
- •Bilirubin ≤ 2 times upper limit of normal (ULN), unless elevation due to MMM
- •AST ≤ 5 times ULN, unless elevation due to MMM
- •Creatinine ≤ 2.5 mg/dL
- •No uncontrolled infection, including tuberculosis
- •No known history of positive purified protein derivative (PPD) untreated by isoniazid therapy
- •Positive PPD with normal chest X-ray and completion of full-course isoniazid therapy allowed
- •No federal medical center inmates or other incarcerated patients
- •No peripheral neuropathy ≥ grade 2
- •No comorbid condition in which the use of study therapy is felt to be potentially harmful
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use 2 forms of effective contraception
- •PRIOR CONCURRENT THERAPY:
- •No chemotherapy (e.g., hydroxyurea, myelosuppressive therapy) within the past 14 days
- •Prior splenectomy for MMM allowed
- •No concurrent hematopoietic growth factors
排除标准
- 未提供
结局指标
主要结局
Confirmed response, defined as a complete or partial response in ≥ 1 of 3 response categories (i.e., anemia, thrombocytopenia, or splenomegaly or hepatomegaly)
次要结局
- Constitutional symptom status and bone marrow morphology
- Overall survival
- Progression-free survival
- Time to progression
- Duration of response
- Toxicity as measured by NCI CTC v 2.0
研究者
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