Genetic Determinations for Side Effects and Response Rate for Patients Receiving Chemotherapy With Diffuse Large Cell Lymphoma
14 maj 2013 uppdaterad av: Washington University School of Medicine
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
52
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Missouri
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St. Louis, Missouri, Förenta staterna, 63110
- Washington University School of Medicine
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: R-CHOP
Patients receiving R-CHOP via standard of care which consists of cyclophosphamide 750 mg/m2 IV day 1 of each 21 day cycle, doxorubicin 50 mg/m2 IV day 1 of each 21 day cycle, vincristine 1.4 mg/m2 IV day 1 of each 21 day cycle, prednisone 100 mg PO days 1-5 of each 21 day cycle, and rituximab 375 mg/m2 IV day 1 of each 21 day cycle.
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Sample Collection for Genotyping prior to cycle 1 treatment of R-CHOP, if patient is enrolled after cycle 1, sample for genotyping should be collected prior to cycle 2.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Negative [F-18]fluorodeoxyglucose-positron emission tomography (FDG-PET) scan after 2 cycles of R-CHOP
Tidsram: Approximately 42 days (2 cycles of R-CHOP)
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Approximately 42 days (2 cycles of R-CHOP)
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Progressionsfri överlevnad
Tidsram: 3 år
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3 år
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Response after six cycles of R-CHOP
Tidsram: Approximately 126 days (6 Cycles of R-CHOP)
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Approximately 126 days (6 Cycles of R-CHOP)
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Grade 3-4 toxicity
Tidsram: Approximately 156 days
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Approximately 156 days
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Amanda Cashen, MD, Washington University School of Medicine
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2005
Primärt slutförande (Faktisk)
1 juli 2008
Avslutad studie (Faktisk)
1 april 2011
Studieregistreringsdatum
Först inskickad
28 december 2007
Först inskickad som uppfyllde QC-kriterierna
28 december 2007
Första postat (Uppskatta)
11 januari 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
16 maj 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 maj 2013
Senast verifierad
1 maj 2013
Mer information
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Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 05-0122
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