RANDOMIZED COMPARISON OF ALTERNATING TRIPLE THERAPY ("ATT") VERUS CHOP IN PATIENTS WITH INTERMEDIATE GRADE LYMPHOMAS AND IMMUNOBLASTIC LYMPHOMAS WITH INTERNATIONAL INDEX 2-5
bleomycin sulfate
+ cisplatin
+ cyclophosphamide
Maladies hématologiques et lymphatiques+10
+ Maladies du Système Immunitaire
+ Troubles immunoprolifératifs
Étude thérapeutique
Résumé
Date de début de l'étude : 25 mai 1994
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: I. Compare, in a randomized setting, the time to treatment failure and the survival of patients with poor-prognosis intermediate-grade or immunoblastic lymphoma treated with the standard regimen of CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) versus the new alternating triple therapy (ATT) of IdSHAP (idarubicin, cisplatin, cytarabine, methylprednisolone), BIdCOS (idarubicin, vincristine, bleomycin, cyclophosphamide, methylprednisolone), and MINE (mesna, ifosfamide, mitoxantrone, etoposide). II. Compare the complete response rate achieved with ATT versus standard CHOP. III. Assess the feasibility of delivering full standard doses of chemotherapy to patients over 60 years of age who receive granulocyte colony stimulating factor support. IV. Compare the predictive capability of the M.D. Anderson Tumor Score System versus the International Index System. OUTLINE: Randomized study. The following acronyms are used: ARA-C Cytarabine, NSC-63878 BLEO Bleomycin, NSC-125066 CDDP Cisplatin, NSC-119875 CTX Cyclophosphamide, NSC-26271 DHAD Mitoxantrone, NSC-301739 DOX Doxorubicin, NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor (source unspecified) IDA Idarubicin, NSC-256439 IFF Ifosfamide, NSC-109724 MePRDL Methylprednisolone succinate Mesna Mercaptoethane sulfonate, NSC-113891 PRED Prednisone, NSC-10023 VCR Vincristine, NSC-67574 VP-16 Etoposide, NSC-141540 Arm I: Sequential 4-, 5-, and 3-Drug Combination Chemotherapy. IdSHAP: IDA/CDDP/ARA-C/MePRDL; followed by BIdCOS: BLEO/IDA/CTX/VCR/MePRDL; followed by MINE: Mesna/IFF/DHAD/VP-16. Arm II: 4-Drug Combination Chemotherapy. CHOP: CTX/DOX/VCR/PRED. PROJECTED ACCRUAL: 218 evaluable patients will be accrued over approximately 31 months to this multicenter study. If either arm is significantly inferior at interim analyses after 31 and 60 treatment failures, consideration will be given to early closure.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.61 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 15 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: Previously untreated non-Hodgkin's lymphoma (NHL) of one of the following histologies: Diffuse large cell Follicular large non-cleaved cell Diffuse mixed cell Immunoblastic At least 2 of the following poor-prognosis factors required: Age over 60 Performance status greater than 1 Any elevation of LDH More than 1 extranodal site Ann Arbor stage III or IV T- and B-cell NHL eligible if meeting all above criteria No primary CNS lymphoma Brain involvement eligible if not primary PATIENT CHARACTERISTICS: Age: Over 15 Performance status: Any status Hematopoietic: (unless secondary to tumor) Absolute granulocyte count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Elevation secondary to tumor discussed with study chairman Renal: (unless secondary to tumor) Creatinine no greater than 1.5 mg/dL Cardiovascular: Left ventricular ejection fraction greater than 55% by echocardiography Pulmonary: No chronic obstructive or restrictive lung disease Pulmonary consultation required in cases of doubt Other: No HIV infection No prior malignancy with less than a 90% 5-year survival probability No patients unable or unlikely to adhere to treatment because of geographic, economic, emotional, or social factors No unwillingness to accept blood product transfusions or other supportive measures (e.g., antibiotics) PRIOR CONCURRENT THERAPY: No prior therapy
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
ExpérimentalCentres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 3 sites
University of Texas - MD Anderson Cancer Center
Houston, United StatesOuvrir University of Texas - MD Anderson Cancer Center dans Google MapsFaculdade de Medicina do ABC
São Paulo, BrazilClinica Alemana
Santiago, Chile