- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00003215
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Aggressive Non-Hodgkin's Lymphoma
Standard Chemotherapy (CHOP Regimen) Versus Sequential High-Dose Chemotherapy With Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas and Poor Prognostic Factors: A Randomized Phase III Study (MISTRAL)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining peripheral stem cell transplantation with more than one drug regimen may kill more tumor cells. It is not known whether receiving standard combination chemotherapy alone is more effective than receiving multiple combination chemotherapy plus peripheral stem cell transplantation for aggressive non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is comparing giving different combination chemotherapy regimens together with peripheral stem cell transplantation to see how well they work in treating patients with newly diagnosed aggressive non-Hodgkin's lymphoma.
Studieöversikt
Status
Betingelser
Intervention / Behandling
- Läkemedel: cyklofosfamid
- Läkemedel: leukovorin kalcium
- Strålning: strålbehandling
- Läkemedel: mitoxantronhydroklorid
- Läkemedel: prednison
- Läkemedel: cytarabin
- Läkemedel: etoposid
- Läkemedel: metotrexat
- Läkemedel: metylprednisolon
- Läkemedel: terapeutiskt hydrokortison
- Läkemedel: vinkristinsulfat
- Läkemedel: doxorubicinhydroklorid
- Procedur: stamcellstransplantation av perifert blod
- Biologisk: filgrastim
- Läkemedel: melfalan
- Läkemedel: CHOP-regimen
- Procedur: benmärgsablation med stamcellsstöd
Detaljerad beskrivning
OBJECTIVES:
- Compare the efficacy of sequential high-dose chemotherapy and autologous peripheral blood stem cell transplantation with standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone) in patients with newly diagnosed aggressive non-Hodgkin's lymphoma and poor prognostic factors.
- Compare the toxic effects of these 2 regimens in these patients.
- Compare the response rates and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive standard chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). Patients receive cyclophosphamide IV over 30 minutes, doxorubicin IV, and vincristine IV on day 1. Patients receive oral prednisone daily on days 1-5. Treatment repeats every 21 days for 6-8 courses. Patients with bulky disease at diagnosis or residual disease after chemotherapy receive radiotherapy 30-60 days after initiation of the last course of CHOP.
Arm II: Patients receive 5 regimens of chemotherapy administered in sequence.
- Regimen A : Patients receive CHOP as in Arm I.
- Regimen B: Three weeks after starting regimen A, patients receive high-dose cyclophosphamide IV over 24 hours on day 1. Patients without initial bone marrow involvement receive filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 3 and continuing until autologous peripheral blood stem cells (PBSC) are harvested. PBSC are harvested on days 13-15 or when blood counts recover. Patients with initial bone marrow involvement do not undergo harvest of PBSC at this time, but receive G-CSF SC daily.
- Regimen C: Two to three weeks after high-dose cyclophosphamide, patients receive vincristine IV and high-dose methotrexate IV over 6 hours on day 2. Patients receive leucovorin calcium IV every 6 hours on days 3-5 beginning 24 hours after initiation of the methotrexate infusion.
- Regimen D: Within 1-2 weeks after the administration of methotrexate in regimen C, patients receive methylprednisolone IV followed 6 hours later by high-dose etoposide IV over 10 hours on day 1. Patients receive methylprednisolone IV on day 2. Patients without initial bone marrow involvement receive G-CSF SC daily beginning on day 3 and continuing until blood counts recover. Patients with initial bone marrow involvement receive G-CSF SC daily until autologous PBSC are harvested. PBSC are harvested on days 10-14 or when blood counts recover.
- Regimen E: Myeloablative therapy and autologous PBSC transplantation begin 16-40 days after the administration of etoposide. Patients receive mitoxantrone IV over 1 hour every 2 hours for 3 doses on day 2 and melphalan IV over 30 minutes on day 5. PBSC are reinfused on day 6 beginning at least 24 hours after the administration of melphalan. Patients receive G-CSF SC or by continuous infusion beginning on day 7.
Patients with bulky disease at diagnosis or residual disease after chemotherapy receive radiotherapy 30-100 days after PBSC transplantation.
Patients at high risk of developing CNS disease receive prophylactic intrathecal chemotherapy. Patients may receive cytarabine, methotrexate, and hydrocortisone or methotrexate and hydrocortisone every 1-2 weeks for 6 courses.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 400 patients will be accrued for this study within 4-5 years.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 3
Kontakter och platser
Studieorter
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Athens, Grekland, 11522
- Saint Savvas Cancer Hospital of Athens
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Milano, Italien, 20141
- European Institute of Oncology
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Basel, Schweiz, CH-4031
- Universitatsspital-Basel
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Bellinzona, Schweiz, CH-6500
- Oncology Institute of Southern Switzerland
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Bern, Schweiz, CH-3010
- Inselspital, Bern
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Chur, Schweiz, CH-7000
- Ratisches Kantons und Regionalspital
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Collonge-Bellerive, Schweiz, CH-1245
- Hopital Cantonal Universitaire de Geneve
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Lausanne, Schweiz, 1011
- Centre Hospitalier Universitaire Vaudois
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St. Gallen, Schweiz, CH-9007
- Kantonsspital - St. Gallen
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Zurich, Schweiz, CH-8008
- Klinik Hirslanden
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Wiesbaden, Tyskland, D-65199
- Dr. Horst-Schmidt-Kliniken
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Vienna, Österrike, A-1090
- Allgemeines Krankenhaus der Stadt Wien
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL)
- Diffuse large B-cell lymphoma
- Primary mediastinal large B-cell lymphoma
- Anaplastic large cell lymphoma (B-cell, T-cell, or null-cell type)
At least two of the following risk factors:
- Stage III or IV
- LDH greater than upper limit of normal (ULN)
- ECOG 2, 3, or 4
- No CNS involvement
PATIENT CHARACTERISTICS:
Age:
- 18 to 60
Performance status:
- See Disease Characteristics
- ECOG 0-4
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- No hepatitis B or C
- AST or ALT no greater than 2 times ULN*
- Bilirubin no greater than 2.34 mg/dL* NOTE: *Unless due to tumor involvement
Renal:
- Creatinine clearance at least 60 mL/min (unless due to tumor involvement)
Cardiovascular:
- No significant heart failure
- LVEF normal
- No active angina pectoris
- No myocardial infarction within the past 6 months
- No major ventricular arrhythmia
Pulmonary:
- No significant lung disorder
Other:
- HIV negative
- No severe active acute or chronic infection
- No severe psychoses
- No prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or nonmelanomatous skin cancer
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for NHL (except emergency therapy, but no more than 1 course of standard chemotherapy)
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy for NHL (except emergency therapy of no greater than 600 cGy radiation)
- No concurrent prophylactic radiotherapy to the brain
Surgery:
- Not specified
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
Samarbetspartners och utredare
Utredare
- Studiestol: Daniel C. Betticher, MD, University Hospital Inselspital, Berne
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
- stadium III vuxen diffust storcelligt lymfom
- stadium III vuxen immunoblastiskt storcelligt lymfom
- stadium IV vuxen diffust storcelligt lymfom
- stadium IV vuxen immunoblastiskt storcelligt lymfom
- stadium III diffust blandat celllymfom hos vuxna
- stadium IV diffust blandat celllymfom hos vuxna
- anaplastiskt storcelligt lymfom
- icke sammanhängande stadium II vuxen diffust storcelligt lymfom
- icke sammanhängande stadium II vuxen diffust blandat celllymfom
- icke sammanhängande stadium II vuxen immunoblastiskt storcelligt lymfom
- sammanhängande stadium II vuxen immunoblastiskt storcelligt lymfom
- stadium I vuxen immunoblastiskt storcelligt lymfom
- angränsande stadium II vuxen diffust storcelligt lymfom
- sammanhängande stadium II vuxen diffust blandat celllymfom
- stadium I vuxen diffust storcelligt lymfom
- stadium I diffust blandat celllymfom hos vuxna
Ytterligare relevanta MeSH-villkor
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lymfoproliferativa störningar
- Lymfatiska sjukdomar
- Immunproliferativa störningar
- Lymfom
- Lymfom, icke-Hodgkin
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Antivirala medel
- Nukleinsyrasynteshämmare
- Enzyminhibitorer
- Analgetika
- Sensoriska systemagenter
- Antiinflammatoriska medel
- Antireumatiska medel
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antiemetika
- Gastrointestinala medel
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Antineoplastiska medel, hormonella
- Neuroprotektiva medel
- Skyddsmedel
- Antineoplastiska medel, Alkylering
- Alkyleringsmedel
- Myeloablativa agonister
- Antineoplastiska medel, fytogena
- Topoisomeras II-hämmare
- Topoisomerasinhibitorer
- Dermatologiska medel
- Mikronäringsämnen
- Antibiotika, antineoplastiska
- Vitaminer
- Reproduktionskontrollmedel
- Motgift
- Vitamin B-komplex
- Abortframkallande medel, icke-steroida
- Abortmedel
- Folsyraantagonister
- Metylprednisolon
- Cyklofosfamid
- Etoposid
- Leucovorin
- Levoleucovorin
- Prednison
- Melphalan
- Doxorubicin
- Liposomal doxorubicin
- Cytarabin
- Metotrexat
- Vincristine
- Mitoxantron
- Hydrokortison
- Hydrokortison 17-butyrat 21-propionat
- Hydrokortisonacetat
- Hydrokortison hemisuccinat
Andra studie-ID-nummer
- SAKK 38/97
- SWS-SAKK-38/97
- EU-97037
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