- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00689845
Combination Chemotherapy and Rituximab in Treating Patients With Primary Mediastinal Diffuse Large B-Cell Lymphoma
A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma (IELSG 26)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab together with one of five different combination chemotherapy regimens may kill more cancer cells.
PURPOSE: This clinical trial is studying giving rituximab together with combination chemotherapy to see how well it works in treating patients with primary mediastinal diffuse large B-cell lymphoma.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
- Legemiddel: cyklofosfamid
- Legemiddel: metotreksat
- Legemiddel: doksorubicinhydroklorid
- Legemiddel: vinkristinsulfat
- Legemiddel: prednison
- Biologisk: bleomycinsulfat
- Biologisk: filgrastim
- Legemiddel: prednisolon
- Legemiddel: ifosfamid
- Legemiddel: etoposid fosfat
- Legemiddel: cytarabin
- Legemiddel: vindesine
- Biologisk: rituximab
Detaljert beskrivelse
OBJECTIVES:
Primary
- To systematically analyze the phenotype and molecular characteristics in patients with primary mediastinal diffuse large B-cell lymphoma.
- To determine the PET response rate following chemoimmunotherapy in these patients.
Secondary
- To obtain data, on a nonrandomized basis, regarding the outcomes of treatment using different chemoimmunotherapy regimens and using or omitting mediastinal radiotherapy, depending upon the practice of the participating institutions.
- To analyze progression-free and overall survival in patients treated with these regimens.
OUTLINE: This is a multicenter study.
Patients receive any one of the following standard chemoimmunotherapy regimens.
- Cohort 1 (R-CHOP-21): Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
- Cohort 2 (R-CHOP-14): Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, oral prednisolone on days 1-5, and filgrastim (G-CSF) subcutaneously (SC) on days 5-12. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
- Cohort 3 (R-MACOP-B): Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV and doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; methotrexate IV on days 8, 36, and 64; vincristine IV on days 8, 22, 36, 50 ,64, and 78; bleomycin IV on days 22, 50, and 78; and oral prednisolone on days 1-84, followed by a taper.
- Cohort 4 (R-VACOP-B): Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV on days 1, 29, and 57; doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; etoposide phosphate IV on days 15, 16, 43, 44, 71, and 72; vincristine IV and bleomycin IV on days 8, 22, 36, 50, 64, and 78; and oral prednisolone on days 1-84, followed by a taper.
- Cohort 5 (R-ACVBP): Patients receive rituximab IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1; vindesine IV and bleomycin IV on days 1 and 5; oral prednisone on days 1-5; methotrexate intrathecally on day 2; and G-CSF SC on days 6-13 for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of 4 courses of R-ACVBP, patients receive consolidation therapy comprising high-dose methotrexate IV, rituximab IV, ifosfamide IV, etoposide phosphate IV, and cytarabine SC according to protocol GELA LNH03-2B.
Patients with an International Prognostic Index score of 4 or greater or disease in close proximity to the spinal cord or cerebral meninges may receive prophylactic treatment to the CNS according to local protocol.
Beginning 8 weeks after completion of chemoimmunotherapy, patients undergo radiotherapy to the original tumor volume according to local protocol.
Fresh or fixed tissue from prior biopsy is obtained if possible. Samples are analyzed for CD3, CD20, CD30, CD15, CD10, Bcl-6, Bcl-2, MAL protein (if available), and Ki-67 via immunohistochemistry.
After completion of study treatment, patients are followed periodically.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
London, Storbritannia
- Rekruttering
- Saint Bartholomew's Hospital
-
Ta kontakt med:
- Contact Person
- Telefonnummer: 44-207-796-3979
- E-post: silvia.montoto@cancer.org.uk
-
-
England
-
Leeds, England, Storbritannia, LS9 7TF
- Rekruttering
- Leeds Cancer Centre at St. James's University Hospital
-
London, England, Storbritannia, SW17 0QT
- Rekruttering
- St. George's Hospital
-
Ta kontakt med:
- Contact Person
- Telefonnummer: 44-208-725-2425
- E-post: rpetteng@sghms.ac.uk
-
Manchester, England, Storbritannia, M20 4BX
- Rekruttering
- Christie Hospital
-
Ta kontakt med:
- Contact Person
- Telefonnummer: 44-845-226-3000
-
Northwood, England, Storbritannia, HA6 2RN
- Rekruttering
- Mount Vernon Cancer Centre at Mount Vernon Hospital
-
Ta kontakt med:
- Contact Person
- Telefonnummer: 44-1923-826-111
-
Sheffield, England, Storbritannia, S1O 2SJ
- Rekruttering
- Cancer Research Centre at Weston Park Hospital
-
Ta kontakt med:
- Contact Person
- Telefonnummer: 44-114-226-5007
- E-post: b.w.hancock@sheffield.ac.uk
-
Southampton, England, Storbritannia, SO16 6YD
- Rekruttering
- Southampton General Hospital
-
Ta kontakt med:
- Contact Person
- Telefonnummer: 44-238-079-6186
- E-post: johnsonp@soton.ac.uk
-
Sutton, England, Storbritannia, SM2 5PT
- Rekruttering
- Royal Marsden - Surrey
-
Ta kontakt med:
- Contact Person
- Telefonnummer: 44-208-661-3279
- E-post: david.cunningham@rmh.nhs.uk
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically confirmed primary mediastinal diffuse large B-cell lymphoma
- CD20-positive disease
- Any stage of disease
- Must have a dominant mass within the anterior mediastinum
PATIENT CHARACTERISTICS:
- ANC ≥ 1.5 x 10^9/L (unless due to lymphoma)
- Platelets ≥ 100 x 10^9/L (unless due to lymphoma)
- WBC ≥ 3.0 x 10^9/L (unless due to lymphoma)
- Serum creatinine ≤ 2 times upper limit of normal (ULN) (unless due to lymphoma)
- AST/ALT ≤ 2.5 times ULN (unless due to lymphoma)
- Total bilirubin ≤ 2.5 times ULN (unless due to lymphoma)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must be fit to receive chemotherapy with curative intent
No evidence of clinically significant cardiac disease* within the past 12 months, including any of the following:
- Symptomatic ventricular arrhythmias
- Congestive heart failure
- Myocardial infarction NOTE: * Cardiac compromise due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.
- No known HIV infection
- No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Able and willing to give informed consent and to undergo staging, including PET scanning
PRIOR CONCURRENT THERAPY:
- No prior treatment for lymphoma
- Prior corticosteroids for up to 1 week allowed for the relief of local compressive symptoms
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Cohort 1
Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1.
Patients also receive oral prednisolone on days 1-5.
Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
|
Gitt IV
Gitt IV
Gitt IV
Gis muntlig
gitt IV
|
Eksperimentell: Cohort 2
Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, oral prednisolone on days 1-5, and filgrastim (G-CSF) subcutaneously (SC) on days 5-12.
Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
|
Gitt IV
Gitt IV
Gitt IV
Gis subkutant
Gis muntlig
gitt IV
|
Eksperimentell: Cohort 3
Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV and doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; methotrexate IV on days 8, 36, and 64; vincristine IV on days 8, 22, 36, 50 ,64, and 78; bleomycin IV on days 22, 50, and 78; and oral prednisolone on days 1-84, followed by a taper.
|
Gitt IV
Gitt IV
Gitt IV
Gitt IV
Gitt IV
Gis muntlig
gitt IV
|
Eksperimentell: Cohort 4
Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV on days 1, 29, and 57; doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; etoposide phosphate IV on days 15, 16, 43, 44, 71, and 72; vincristine IV and bleomycin IV on days 8, 22, 36, 50, 64, and 78; and oral prednisolone on days 1-84, followed by a taper.
|
Gitt IV
Gitt IV
Gitt IV
Gitt IV
Gis muntlig
Gitt IV
gitt IV
|
Eksperimentell: Cohort 5
Patients receive rituximab IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1; vindesine IV and bleomycin IV on days 1 and 5; oral prednisone on days 1-5; methotrexate intrathecally on day 2; and G-CSF SC on days 6-13 for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of 4 courses of R-ACVBP, patients receive consolidation therapy comprising high-dose methotrexate IV, rituximab IV, ifosfamide IV, etoposide phosphate IV, and cytarabine SC according to protocol GELA LNH03-2B.
|
Gitt IV
Gitt IV
Gitt IV
Gis muntlig
Gitt IV
Gis subkutant
Gitt IV
Gitt IV
Gis subkutant
Gitt IV
gitt IV
|
Hva måler studien?
Primære resultatmål
Resultatmål |
---|
Complete response rate on PET scanning at the completion of chemoimmunotherapy
|
Sekundære resultatmål
Resultatmål |
---|
Progresjonsfri overlevelse
|
Død
|
Overlevelsestid
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Peter Johnson, MD, University Hospital Southampton Nhs Foundation Trust
Studierekorddatoer
Studer hoveddatoer
Studiestart
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Lymfesykdommer
- Immunproliferative lidelser
- Lymfom
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Nukleinsyresyntesehemmere
- Enzymhemmere
- Anti-inflammatoriske midler
- Antirevmatiske midler
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Antineoplastiske midler, fytogene
- Topoisomerase II-hemmere
- Topoisomerasehemmere
- Antineoplastiske midler, immunologiske
- Dermatologiske midler
- Antibiotika, antineoplastisk
- Reproduktive kontrollmidler
- Abortfremkallende midler, ikke-steroide
- Aborterende midler
- Folsyreantagonister
- Prednisolon
- Cyklofosfamid
- Etoposid
- Etoposid fosfat
- Ifosfamid
- Rituximab
- Prednison
- Doxorubicin
- Liposomal doksorubicin
- Cytarabin
- Metotreksat
- Vincristine
- Bleomycin
- Vindesine
Andre studie-ID-numre
- CDR0000588011
- USCTU-IELSG-26-RHM-CAN0546
- EU-20818
- EudraCT 2006-005794-22
- USCTU-07/Q1704/68
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