A Phase I-II Study of Pentostatin With Cyclophosphamide for Previously Treated Patients With Intermediate and High-Risk Chronic Lymphocytic Leukemia
filgrastim
+ rituximab
+ cyclophosphamide
Troubles des Protéines Sanguines+24
+ Maladies Cardiovasculaires
+ Maladie chronique
Étude thérapeutique
Résumé
Date de début de l'étude : 1 septembre 1998
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the dose of cyclophosphamide, with filgrastim (G-CSF) support, that can be safely administered with pentostatin and rituximab in patients with previously treated intermediate- or high-risk chronic lymphocytic leukemia or other low-grade B-cell malignancies. (Phase I closed to accrual effective 11/27/2001.) Characterize the toxicity of this regimen in these patients. Determine the incidence of response in these patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of cyclophosphamide (CTX). Phase I: Patients receive CTX IV followed by pentostatin IV on day 1 of course 1. Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 3 and continuing until blood counts recover. During the second and subsequent courses, patients receive CTX IV, pentostatin IV, and rituximab IV on day 1. Patients also receive G-CSF as in course 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with at least a partial response after the third course receive an additional 3 courses. Cohorts of 3-6 patients receive escalating doses of CTX until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. (Phase I closed to accrual effective 11/27/2001.) Phase II: Patients receive CTX at the recommended phase II dose and treatment as above. Patients are followed at least every 3 months for 1 year and then periodically thereafter. PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for the phase I portion of this study. (Phase I closed to accrual effective 11/27/2001.) A total of 14-30 patients will be accrued for the phase II portion of this study within 2.5 years.
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.60 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 18 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: Intermediate- or high-risk chronic lymphocytic leukemia (CLL) as defined by the three-stage Rai system Rai intermediate disease must be active disease (including weight loss, fatigue, fevers, evidence of progressive marrow failure, splenomegaly, progressive lymphadenopathy, and progressive lymphocytosis with a rapid doubling time) Other low-grade B-cell neoplasms, including small lymphocytic lymphoma (and its variants), Waldenstrom's macroglobulinemia, and follicular lymphoma allowed Autoimmune hemolytic anemia or autoimmune thrombocytopenia allowed regardless of disease stage B-cells demonstrated by immunophenotypic (or immunohistochemical) analysis of the malignant lymphocytes Must be previously treated For CLL, absolute lymphocytosis in the blood at least 5,000 lymphocytes/mm^3 OR Bone marrow lymphocytosis at least 30% of all nucleated cells No Rai intermediate-risk disease that meets the criteria of Montserrat "smoldering leukemia" NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: More than 4 weeks Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: No active infections requiring systemic antibiotics Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy Concurrent intravenous immunoglobulin allowed Concurrent epoetin alfa allowed Chemotherapy: At least 4 weeks since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Concurrent prednisone therapy allowed as long as dose is stable or decreasing over the past 4 weeks No increase in prednisone therapy while on study Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: Not specified
Centres 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 1 site
Memorial Sloan-Kettering Cancer Center
New York, United StatesOuvrir Memorial Sloan-Kettering Cancer Center dans Google Maps