Lessons Learned from the Investigational Device Exemption Review of Children's Oncology Group Trial AAML1031

被引：11

作者：

Meshinchi, Soheil ^{[2
]}

Hunger, Stephen P. ^{[3
,4
]}

Aplenc, Richard ^{[5
,6
]}

Adamson, Peter C. ^{[5
]}

Jessup, J. Milburn ^{[1
,7
]}

机构：

[1] NCI, Canc Diag Program, Div Canc Treatment & Diag, Bethesda, MD 20892 USA

[2] Fred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98104 USA

[3] Childrens Hosp Colorado, Ctr Canc & Blood Disorders, Aurora, CO USA

[4] Univ Colorado, Sch Med, Dept Pediat, Aurora, CO USA

[5] Childrens Hosp Philadelphia, Philadelphia, PA 19104 USA

[6] Univ Penn, Sch Med, Philadelphia, PA 19104 USA

[7] Childrens Oncol Grp, Arcadia, CA USA

来源：

CLINICAL CANCER RESEARCH | 2012年 / 18卷 / 06期

关键词：

ACUTE MYELOID-LEUKEMIA; BONE-MARROW-TRANSPLANTATION; STEM-CELL TRANSPLANTATION; CANCER GROUP; SORAFENIB; COMPLICATIONS; REGRESSION; REMISSION; PATIENT; DISEASE;

D O I：

10.1158/1078-0432.CCR-11-2205

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

The U.S. Food and Drug Administration is now exerting its regulatory authority over the use of molecular diagnostics and related assays for medical decision making in clinical trials, by performing pre-Investigational Device Exemption reviews in all phases of clinical trials. In this review, we assess the analytical performance of the assay for the diagnostic, and consider how that performance affects the diagnostic and the patient and their risks and benefits from treatment. We also discuss the process involved in the first review of a new Children's Oncology Group phase III trial in acute myelogenous leukemia. The lessons learned and recommendations for how to prepare for and incorporate this new level of regulatory review into the protocol development process are presented. Clin Cancer Res; 18(6); 1547-54. (C)2012 AACR.

引用

页码：1547 / 1554

页数：8

共 22 条

[1]

[Anonymous], GUID IND FO IN PRESS

[2] Impact of Disease Risk on Efficacy of Matched Related Bone Marrow Transplantation for Pediatric Acute Myeloid Leukemia: The Children's Oncology Group [J].

Horan, John T. ;

Alonzo, Todd A. ;

Lyman, Gary H. ;

Gerbing, Robert B. ;

Lange, Beverly J. ;

Ravindranath, Yaddanapudi ;

Becton, David ;

Smith, Franklin O. ;

Woods, William G. .

JOURNAL OF CLINICAL ONCOLOGY, 2008, 26 (35) :5797-5801

[3]

Kolata G., 2011, NY TIMES 0718

[4] Outcomes in CCG-2961, a Children's Oncology Group Phase 3 Trial for untreated pediatric acute myeloid leukemia: a report from the Children's Oncology Group [J].

Lange, Beverly J. ;

Smith, Franklin O. ;

Feusner, James ;

Barnard, Dorothy R. ;

Dinndorf, Patricia ;

Feig, Stephen ;

Heerema, Nyla A. ;

Arndt, Carola ;

Arceci, Robert J. ;

Seibel, Nita ;

Weiman, Margie ;

Dusenbery, Kathryn ;

Shannon, Kevin ;

Luna-Fineman, Sandra ;

Gerbing, Robert B. ;

Alonzo, Todd A. .

BLOOD, 2008, 111 (03) :1044-1053

[5] Fit-for-purpose method development and validation for successful biomarker measurement [J].

Lee, JW ;

Devanarayan, V ;

Barrett, YC ;

Weiner, R ;

Allinson, J ;

Fountain, S ;

Keller, S ;

Weinryb, I ;

Green, M ;

Duan, L ;

Rogers, JA ;

Millham, R ;

O'Brien, PJ ;

Sailstad, J ;

Khan, M ;

Ray, C ;

Wagner, JA .

PHARMACEUTICAL RESEARCH, 2006, 23 (02) :312-328

[6] Complete resolution of leukemia cutis with sorafenib in an acute myeloid leukemia patient with FLT3-ITD mutation [J].

Lee, Sung Ho ;

Paietta, Elisabeth ;

Racevskis, Janis ;

Wiernik, Peter H. .

AMERICAN JOURNAL OF HEMATOLOGY, 2009, 84 (10) :701-702

[7] Cyclophosphamide metabolism, liver toxicity, and mortality following hematopoietic stem cell transplantation [J].

McDonald, GB ;

Slattery, JT ;

Bouvier, ME ;

Ren, S ;

Batchelder, AL ;

Kalhorn, TF ;

Schoch, HG ;

Anasetti, C ;

Gooley, T .

BLOOD, 2003, 101 (05) :2043-2048

[8] Hepatobiliary Complications of Hematopoietic Cell Transplantation, 40 Years On [J].

McDonald, George B. .

HEPATOLOGY, 2010, 51 (04) :1450-1460

[9]

Meshinchi S, 2007, ASH ANN M, V110, P1429

[10] Clinical implications of FLT3 mutations in pediatric AML [J].

Meshinchi, Soheil ;

Alonzo, Todd A. ;

Stirewalt, Derek L. ;

Zwaan, Michel ;

Zimmerman, Martin ;

Reinhardt, Dirk ;

Kaspers, Gertjan J. L. ;

Heerema, Nyla A. ;

Gerbing, Robert ;

Lange, Beverly J. ;

Radich, Jerald P. .

BLOOD, 2006, 108 (12) :3654-3661

← 1 2 3 →