NCT00952237已完成1 期
Immune Mobilization of Autologous Peripheral Blood Stem Cells Using Interleukin-2 and GM-CSF
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Can IL-2 be administered with GM-CSF to efficiently mobilize autologous peripheral blood stem cells. This study will determine the maximum tolerated dose of IL-2 and the optimal biological dose with GM-CSF for stem cell mobilization.
研究概览
简要总结
We postulate that the combination of IL-2 and GM-CSF immunotherapy will efficiently mobilize autologous peripheral blood stem cells and activated immune effector cells in patients with a hematologic malignancy. These activated effector cells will improve the immune function of the graft. These hypotheses will be tested using this proposed clinical trial to mobilize autologous peripheral blood stem cells pre-transplantation.
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
- •All patients must have pathologic diagnosis of one of the following malignancies: Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma or other plasma cell dyscrasia (Waldenstrom, Amyloidosis), Leukemia (AML, ALL, CLL)
- •Prior Treatment: > 2 weeks prior to initiation of therapy.
- •Performance Status: Karnofsky > 70%
- •Life Expectancy > 4 months
- •Bone Marrow: bone marrow biopsy and aspirate
- •Blood counts: The patient must have adequate bone marrow function, i.e. a total WBC of > 2,000/ul, a Hgb of > 7 mg/dl, and a platelet count of > 50,000/ul, unless this abnormality is believed to be due to the underlying disease.
- •Pulmonary function tests: DLCO > 55% predicted.
- •Cardiac: Left ventricular ejection fraction of > 40% by radionuclide scan or echocardiography.
- •Liver function tests (bilirubin, alkaline phosphatase, and SGOT/SGPT) < 3 x normal (unless believed to be elevated due to disease).
- •No significant co-morbid medical or psychiatric illness that would significantly compromise the patient's clinical care and chances of survival.
- •Informed Consent: Informed consent must be signed prior to the treatment. Patients must be aware of the neoplastic nature of their disease and willingly consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side effects, risks and discomforts. The patient is not deemed eligible if there is any other serious medical or psychiatric illness that would prevent informed consent. (Human protection committee approval of this protocol and a consent form is required.)
排除标准
- •Medical, social, or psychological factors which would prevent the patient from receiving or cooperating with the full course of therapy.
- •Evidence on physical exam, LP, CT, or MRI scans of CNS involvement with malignancy.
- •Uncontrolled or severe cardiovascular disease, including recent (< 6 months) myocardial infarction, congestive heart failure, angina (symptomatic despite optimal medical management), life-threatening arrhythmia, or hypertension or clinically significant obstructive/restrictive pulmonary disease.
- •Serology positive for HIV
- •History of seizures.
- •Concurrent or expected need for therapy with systemic corticosteroids (since systemic steroids may suppress the effects of IL-2).
- •Current and clinically significant pleural effusion, pericardial effusion, or ascites.
- •Positive pregnancy test or presence of lactation.
- •Uncontrolled active infection.
- •Documented hypersensitivity to any of the drugs used in the protocol.
- •No concomitant, ongoing malignancy that is life-threatening, based on PI's evaluation
研究组 & 干预措施
IL-2 and GM-CSF for Mobilization
Experimental
Immune Mobilization of Autologous Peripheral Blood Stem Cells Using Interleukin-2 and GM-CSF
干预措施: IL-2 (Drug)
IL-2 and GM-CSF for Mobilization
Experimental
Immune Mobilization of Autologous Peripheral Blood Stem Cells Using Interleukin-2 and GM-CSF
干预措施: GM-CSF (Drug)
结局指标
主要结局
Can IL-2 be administered with GM-CSF to efficiently mobilize autologous peripheral blood stem cells. This study will determine the maximum tolerated dose of IL-2 and the optimal biological dose with GM-CSF for stem cell mobilization.
时间窗: 5 Years
次要结局
- Will immune-mobilized stem cell products be well tolerated once infused into patients and will engraft normally following high-dose chemotherapy and APBSCT.(5 Years)
研究者
Kenneth Meehan
Director, Bone Marrow Transplant Program
Dartmouth-Hitchcock Medical Center
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
Immunotherapy by autologous peripheral blood mononuclear cells and GM-CSF for hepatocellular carcinoma undergoing radiofrequency thermal ablation - HCC thermal ablation and immunotherapy combined treatmentpatients with hepatocellular carcinomaMedDRA version: 9.1Level: LLTClassification code 10059319Term: Hepatic cancer stage IIEUCTR2008-003925-17-ITAZIENDA OSPEDALIERA DI PARMA
已完成
2 期
Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon Alfa in Treating Patients With Advanced Multiple MyelomaRefractory Multiple MyelomaStage I Multiple MyelomaStage II Multiple MyelomaStage III Multiple MyelomaNCT00006244Fred Hutchinson Cancer Center36
已完成
4 期
Combination of Autologous MSC and HSC Infusion in Patients With Decompensated CirrhosisCirrhosis, LiverNCT04243681Asian Institute of Gastroenterology, India5
进行中（未招募）
1 期
CD34+ cell transplantation for patients with chronic kidney diseasechronic kidney diseaseJPRN-jRCTb030210237Ohtake Takayasu4
已完成
2 期
Chemotherapy and G-CSF for MobilizationMultiple MyelomaNCT03442673Insel Gruppe AG, University Hospital Bern137