Evaluation of the Drug Plerixafor in Combination With Chemotherapy and G-CSF for Stem Cell Collection
2014年9月16日 更新者：Edmund Waller、Emory University
Evaluation of Plerixafor (Mozobil ™, AMD3100) in Combination With Chemotherapy and G-CSF for CD34+ Cell Mobilization
The purpose of this study is to test whether the addition of the drug plerixafor to treatment with chemotherapy and G-CSF can better activate your bone marrow stem cells to improve the chances of transplant. The study will look for the activation of a certain type of blood cell, called CD34+ cells in patients who receive plerixafor, chemotherapy and G-CSF. The investigators will follow the number of patients that achieve the target numbers of CD34+ cells. The number of patients achieving the target level of CD34+ cells, and the total number of CD34+ cells, will be compared to the numbers in previous studies testing just chemotherapy and G-CSF, without plerixafor.
The investigators will also test the safety of the combination of plerixafor with chemotherapy and G-CSF and look at the success of the transplantation after 12 months.
研究概览
研究类型
介入性
注册 (实际的)
45
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Georgia
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Atlanta、Georgia、美国、30322
- Emory University Winship Cancer Institute
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age 18-70 years
- Multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL) patients in first or second complete or partial remission
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Up to 3 prior treatment regimens
- Meet all eligibility requirements for autologous transplant
- Adequate marrow function defined as white blood cells (WBC) >3,000; ANC >1,500/mm3; platelets >75,000/mm3
- Adequate renal function defined as creatinine clearance > 30 mL/min by Cockcroft-Gault
- Adequate liver function defined as aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/bilirubin < 2 times upper limit of normal
- Able to provide informed consent
- Women not pregnant and agree to use contraception
Exclusion Criteria:
- High risk co-morbidities for acute treatment complications (e.g., symptomatic coronary artery disease)
- Brain metastases or carcinomatous meningitis
- Previous treatment with high dose chemotherapy and autologous transplant
- Previous attempt to collect B-hematopoietic progenitor cells (HPCs) following mobilization with growth factors alone, growth factors and chemotherapy, or plerixafor and growth factors
- Acute infection or unexplained fever >38°C
- Weight > 175% of ideal body weight as defined by the Devine equation
- Experimental therapy within 4 weeks
- Cytokine administration in the previous 14 days
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Plerixafor + Chemo and G-CSF
Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.
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240 µg/kg subcutaneous injection on the day that the absolute neutrophil count (ANC) is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis
大体时间：Within the first 4 days following the first dose of Plerixafor
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Within the first 4 days following the first dose of Plerixafor
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Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg
大体时间：Within the first 4 days following the first dose of Plerixafor
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Within the first 4 days following the first dose of Plerixafor
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Average Number of Days for Engraftment (Engraftment Defined as Absolute Neutrophil Count>500)
大体时间：Within the first 4 days following the first dose of Plerixafor
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Within the first 4 days following the first dose of Plerixafor
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Edmund Waller, MD, PhD、Emory University Winship Cancer Institute
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Smith TJ, Khatcheressian J, Lyman GH, Ozer H, Armitage JO, Balducci L, Bennett CL, Cantor SB, Crawford J, Cross SJ, Demetri G, Desch CE, Pizzo PA, Schiffer CA, Schwartzberg L, Somerfield MR, Somlo G, Wade JC, Wade JL, Winn RJ, Wozniak AJ, Wolff AC. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. J Clin Oncol. 2006 Jul 1;24(19):3187-205. doi: 10.1200/JCO.2006.06.4451. Epub 2006 May 8.
- Mazumder A, Kaufman J, Niesvizky R, Lonial S, Vesole D, Jagannath S. Effect of lenalidomide therapy on mobilization of peripheral blood stem cells in previously untreated multiple myeloma patients. Leukemia. 2008 Jun;22(6):1280-1; author reply 1281-2. doi: 10.1038/sj.leu.2405035. Epub 2007 Nov 22. No abstract available.
- Lazarus HM, Loberiza FR Jr, Zhang MJ, Armitage JO, Ballen KK, Bashey A, Bolwell BJ, Burns LJ, Freytes CO, Gale RP, Gibson J, Herzig RH, LeMaistre CF, Marks D, Mason J, Miller AM, Milone GA, Pavlovsky S, Reece DE, Rizzo JD, van Besien K, Vose JM, Horowitz MM. Autotransplants for Hodgkin's disease in first relapse or second remission: a report from the autologous blood and marrow transplant registry (ABMTR). Bone Marrow Transplant. 2001 Feb;27(4):387-96. doi: 10.1038/sj.bmt.1702796.
- Lemoli RM, Martinelli G, Zamagni E, Motta MR, Rizzi S, Terragna C, Rondelli R, Ronconi S, Curti A, Bonifazi F, Tura S, Cavo M. Engraftment, clinical, and molecular follow-up of patients with multiple myeloma who were reinfused with highly purified CD34+ cells to support single or tandem high-dose chemotherapy. Blood. 2000 Apr 1;95(7):2234-9.
- Siena S, Bregni M, Brando B, Ravagnani F, Bonadonna G, Gianni AM. Circulation of CD34+ hematopoietic stem cells in the peripheral blood of high-dose cyclophosphamide-treated patients: enhancement by intravenous recombinant human granulocyte-macrophage colony-stimulating factor. Blood. 1989 Nov 1;74(6):1905-14.
- Cassens U, Momkvist PH, Zuehlsdorf M, Mohr M, Kienast J, Berdel WE, Sibrowski W. Kinetics of standardized large volume leukapheresis (LVL) in patients do not show a recruitment phenomenon of peripheral blood progenitor cells (PBPC). Bone Marrow Transplant. 2001 Jul;28(1):13-20. doi: 10.1038/sj.bmt.1703082.
- Koenigsmann M, Jentsch-Ullrich K, Mohren M, Becker E, Heim M, Franke A. The role of diagnosis in patients failing peripheral blood progenitor cell mobilization. Transfusion. 2004 May;44(5):777-84. doi: 10.1111/j.0041-1132.2004.03321.x.
- Hicks ML, Lonial S, Langston A, Flowers C, Roback JD, Smith KJ, Mossavi Sai S, Teagarden D, Hamilton ES, Waller EK, Kaufman J. Optimizing the timing of chemotherapy for mobilizing autologous blood hematopoietic progenitor cells. Transfusion. 2007 Apr;47(4):629-35. doi: 10.1111/j.1537-2995.2007.01164.x. Erratum In: Transfusion. 2007 May;47(5):952. Kaufman, Jonathan [added].
- Li J, Hamilton E, Vaughn L, Graiser M, Renfroe H, Lechowicz MJ, Langston A, Prichard JM, Anderson D, Gleason C, Lonial S, Flowers CR, Kaufman JL, Waller EK. Effectiveness and cost analysis of "just-in-time" salvage plerixafor administration in autologous transplant patients with poor stem cell mobilization kinetics. Transfusion. 2011 Oct;51(10):2175-82. doi: 10.1111/j.1537-2995.2011.03136.x. Epub 2011 Apr 14.
- Kumar S, Dispenzieri A, Lacy MQ, Hayman SR, Buadi FK, Gastineau DA, Litzow MR, Fonseca R, Roy V, Rajkumar SV, Gertz MA. Impact of lenalidomide therapy on stem cell mobilization and engraftment post-peripheral blood stem cell transplantation in patients with newly diagnosed myeloma. Leukemia. 2007 Sep;21(9):2035-42. doi: 10.1038/sj.leu.2404801. Epub 2007 Jun 21.
- Paripati H, Stewart AK, Cabou S, Dueck A, Zepeda VJ, Pirooz N, Ehlenbeck C, Reeder C, Slack J, Leis JF, Boesiger J, Torloni AS, Fonseca R, Bergsagel PL. Compromised stem cell mobilization following induction therapy with lenalidomide in myeloma. Leukemia. 2008 Jun;22(6):1282-4. doi: 10.1038/sj.leu.2405100. Epub 2008 Jan 24. No abstract available.
- Christopher MJ, Rao M, Liu F, Woloszynek JR, Link DC. Expression of the G-CSF receptor in monocytic cells is sufficient to mediate hematopoietic progenitor mobilization by G-CSF in mice. J Exp Med. 2011 Feb 14;208(2):251-60. doi: 10.1084/jem.20101700. Epub 2011 Jan 31.
- Ponomaryov T, Peled A, Petit I, Taichman RS, Habler L, Sandbank J, Arenzana-Seisdedos F, Magerus A, Caruz A, Fujii N, Nagler A, Lahav M, Szyper-Kravitz M, Zipori D, Lapidot T. Induction of the chemokine stromal-derived factor-1 following DNA damage improves human stem cell function. J Clin Invest. 2000 Dec;106(11):1331-9. doi: 10.1172/JCI10329.
- Jung Y, Wang J, Schneider A, Sun YX, Koh-Paige AJ, Osman NI, McCauley LK, Taichman RS. Regulation of SDF-1 (CXCL12) production by osteoblasts; a possible mechanism for stem cell homing. Bone. 2006 Apr;38(4):497-508. doi: 10.1016/j.bone.2005.10.003. Epub 2005 Dec 5.
- DiPersio JF, Stadtmauer EA, Nademanee A, Micallef IN, Stiff PJ, Kaufman JL, Maziarz RT, Hosing C, Fruehauf S, Horwitz M, Cooper D, Bridger G, Calandra G; 3102 Investigators. Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma. Blood. 2009 Jun 4;113(23):5720-6. doi: 10.1182/blood-2008-08-174946. Epub 2009 Apr 10.
- Kaufman JL, Flowers CR, Rados KD, Calandra GB, Vose JM, Hewes LB, Lonial S, Langston AA, Khoury HJ, Lechowicz MJ, Waller EK. A prospective clinical trial evaluating the safety and efficacy of the combination of rituximab and plerixafor as a mobilization regimen for patients with lymphoma. Transfusion. 2013 Jan;53(1):76-84. doi: 10.1111/j.1537-2995.2012.03719.x. Epub 2012 May 25.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年3月1日
初级完成 (实际的)
2012年5月1日
研究完成 (实际的)
2014年2月1日
研究注册日期
首次提交
2010年3月26日
首先提交符合 QC 标准的
2010年3月29日
首次发布 (估计)
2010年3月30日
研究记录更新
最后更新发布 (估计)
2014年9月29日
上次提交的符合 QC 标准的更新
2014年9月16日
最后验证
2014年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.