| December 28, 2007 |
| October 27, 2008 |
| February 2005 |
| July 2010 (final data collection date for primary outcome measure) |
| Negative [F-18]fluorodeoxyglucose-positron emission tomography (FDG-PET) scan after 2 cycles of R-CHOP [ Time Frame: 2 cycles of R-CHOP ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00590941 on ClinicalTrials.gov Archive Site |
- Response after six cycles of R-CHOP [ Time Frame: 6 Cycles of R-CHOP ] [ Designated as safety issue: No ]
- progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Grade 3-4 toxicity [ Time Frame: 6 cycles of R-CHOP ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| Genetic Determinations for Side Effects and Response Rate for Patients Receiving Chemotherapy With Diffuse Large Cell Lymphoma |
| Candidate Gene Polymorphisms and Response to Rituximab-CHOP in Patients With Diffuse Large Cell Lymphoma |
The purpose of this study is to determine whether people have genes that make them more likely to respond to chemotherapy and/or have side effects from chemotherapy for diffuse large cell lymphoma. |
Upon enrollment in the study, patients will have a blood sample collected for genotyping of the FCGR3A gene (immunoglobulin Fc G receptor IIIa), the ABCB1 gene (ATP Binding Cassette Beta 1; also called MDR1), and other candidate genes. Patients will be treated with R-CHOP for six cycles, which is standard therapy for advanced stage DLCL. Response will be monitored by an FDG-PET scan performed after 2 cycles of R-CHOP and restaging exams performed upon completion of chemotherapy. Gene polymorphisms will be analyzed to establish which polymorphisms predict response to R-CHOP. |
| |
| Interventional |
| Other, Randomized, Open Label, Single Group Assignment, Efficacy Study |
- Lymphoma
- Diffuse Large Cell
|
- Genetic: Blood draw
- Drug: Rituximab
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Prednisone
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| |
- [No authors listed] A clinical evaluation of the International Lymphoma Study Group classification of non-Hodgkin's lymphoma. The Non-Hodgkin's Lymphoma Classification Project. Blood. 1997 Jun 1;89(11):3909-18.
- McKelvey EM, Gottlieb JA, Wilson HE, Haut A, Talley RW, Stephens R, Lane M, Gamble JF, Jones SE, Grozea PN, Gutterman J, Coltman C, Moon TE. Hydroxyldaunomycin (Adriamycin) combination chemotherapy in malignant lymphoma. Cancer. 1976 Oct;38(4):1484-93.
- Fisher RI, Gaynor ER, Dahlberg S, Oken MM, Grogan TM, Mize EM, Glick JH, Coltman CA Jr, Miller TP. Comparison of a standard regimen (CHOP) with three intensive chemotherapy regimens for advanced non-Hodgkin's lymphoma. N Engl J Med. 1993 Apr 8;328(14):1002-6.
- Vose JM, Link BK, Grossbard ML, Czuczman M, Grillo-Lopez A, Gilman P, Lowe A, Kunkel LA, Fisher RI. Phase II study of rituximab in combination with chop chemotherapy in patients with previously untreated, aggressive non-Hodgkin's lymphoma. J Clin Oncol. 2001 Jan 15;19(2):389-97.
- Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jan 24;346(4):235-42.
- Elstrom R, Guan L, Baker G, Nakhoda K, Vergilio JA, Zhuang H, Pitsilos S, Bagg A, Downs L, Mehrotra A, Kim S, Alavi A, Schuster SJ. Utility of FDG-PET scanning in lymphoma by WHO classification. Blood. 2003 May 15;101(10):3875-6. Epub 2003 Jan 16.
- Lavely WC, Delbeke D, Greer JP, Morgan DS, Byrne DW, Price RR, Hallahan DE. FDG PET in the follow-up management of patients with newly diagnosed Hodgkin and non-Hodgkin lymphoma after first-line chemotherapy. Int J Radiat Oncol Biol Phys. 2003 Oct 1;57(2):307-15.
- Zinzani PL, Magagnoli M, Chierichetti F, Zompatori M, Garraffa G, Bendandi M, Gherlinzoni F, Cellini C, Stefoni V, Ferlin G, Tura S. The role of positron emission tomography (PET) in the management of lymphoma patients. Ann Oncol. 1999 Oct;10(10):1181-4.
- Mikhaeel NG, Timothy AR, O'Doherty MJ, Hain S, Maisey MN. 18-FDG-PET as a prognostic indicator in the treatment of aggressive Non-Hodgkin's Lymphoma-comparison with CT. Leuk Lymphoma. 2000 Nov;39(5-6):543-53.
- Spaepen K, Stroobants S, Dupont P, Vandenberghe P, Thomas J, de Groot T, Balzarini J, De Wolf-Peeters C, Mortelmans L, Verhoef G. Early restaging positron emission tomography with ( 18)F-fluorodeoxyglucose predicts outcome in patients with aggressive non-Hodgkin's lymphoma. Ann Oncol. 2002 Sep;13(9):1356-63.
- Jerusalem G, Beguin Y, Fassotte MF, Najjar F, Paulus P, Rigo P, Fillet G. Whole-body positron emission tomography using 18F-fluorodeoxyglucose for posttreatment evaluation in Hodgkin's disease and non-Hodgkin's lymphoma has higher diagnostic and prognostic value than classical computed tomography scan imaging. Blood. 1999 Jul 15;94(2):429-33.
- Römer W, Hanauske AR, Ziegler S, Thödtmann R, Weber W, Fuchs C, Enne W, Herz M, Nerl C, Garbrecht M, Schwaiger M. Positron emission tomography in non-Hodgkin's lymphoma: assessment of chemotherapy with fluorodeoxyglucose. Blood. 1998 Jun 15;91(12):4464-71.
- Kostakoglu L, Coleman M, Leonard JP, Kuji I, Zoe H, Goldsmith SJ. PET predicts prognosis after 1 cycle of chemotherapy in aggressive lymphoma and Hodgkin's disease. J Nucl Med. 2002 Aug;43(8):1018-27.
- Jerusalem G, Beguin Y, Fassotte MF, Najjar F, Paulus P, Rigo P, Fillet G. Persistent tumor 18F-FDG uptake after a few cycles of polychemotherapy is predictive of treatment failure in non-Hodgkin's lymphoma. Haematologica. 2000 Jun;85(6):613-8.
- Alizadeh AA, Eisen MB, Davis RE, Ma C, Lossos IS, Rosenwald A, Boldrick JC, Sabet H, Tran T, Yu X, Powell JI, Yang L, Marti GE, Moore T, Hudson J Jr, Lu L, Lewis DB, Tibshirani R, Sherlock G, Chan WC, Greiner TC, Weisenburger DD, Armitage JO, Warnke R, Staudt LM, et al. Distinct types of diffuse large B-cell lymphoma identified by gene expression profiling. Nature. 2000 Feb 3;403(6769):503-11.
- Rosenwald A, Wright G, Chan WC, Connors JM, Campo E, Fisher RI, Gascoyne RD, Muller-Hermelink HK, Smeland EB, Giltnane JM, Hurt EM, Zhao H, Averett L, Yang L, Wilson WH, Jaffe ES, Simon R, Klausner RD, Powell J, Duffey PL, Longo DL, Greiner TC, Weisenburger DD, Sanger WG, Dave BJ, Lynch JC, Vose J, Armitage JO, Montserrat E, López-Guillermo A, Grogan TM, Miller TP, LeBlanc M, Ott G, Kvaloy S, Delabie J, Holte H, Krajci P, Stokke T, Staudt LM; Lymphoma/Leukemia Molecular Profiling Project. The use of molecular profiling to predict survival after chemotherapy for diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jun 20;346(25):1937-47.
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| |
| Active, not recruiting |
| 50 |
| July 2010 |
| July 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Histologically proven diffuse large B-cell non-Hodgkin's lymphoma according to the WHO classification, with measurable or evaluable disease
- No prior therapy for NHL. Patient may be enrolled in this study after the first cycle of R-CHOP if all screening evaluations were performed prior to the first cycle of chemotherapy.
- Ann Arbor stage 3 or 4
- Age greater than or equal to 18 years
- Patient must give written informed consent.
- A patient enrolled in another clinical trial may also enroll in this study if the other trial has an R-CHOP treatment arm and the patient is randomized to the R-CHOP only arm. Registration to this study must occur after randomization in the other trial.
Exclusion Criteria:
- CNS involvement
- Known HIV positive
- T-cell lymphoma or history of indolent NHL
- Patients who will be treated with radiation therapy
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00590941 |
| Amanda Cashen, MD, Washington University School of Medicine |
| 05-0122, 05-0122 |
| Washington University School of Medicine |
| BJC Foundation |
| Principal Investigator: |
Amanda Cashen, MD |
Washington University School of Medicine |
|
|
| Washington University School of Medicine |
| July 2008 |