A Phase II Study of Thrice Weekly Apolizumab in Patients With Chronic Lymphocytic Leukemia : CRC Master Protocol
apolizumab
+ laboratory biomarker analysis
+ pharmacological study
Maladie chronique+12
+ Maladies Hématologiques
+ Maladies du Système Immunitaire
Étude thérapeutique
Résumé
Date de début de l'étude : 1 août 2004
Date à laquelle le premier participant a commencé l'étude.PRIMARY OBJECTIVES: I. Determine the response rate and progression-free survival rate in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or noncontiguous stage II or stage III or IV small lymphocytic lymphoma treated with apolizumab. II. Determine the safety of this drug, in terms of the frequency and severity of treatment-related adverse events, in these patients. SECONDARY OBJECTIVES: I. Determine clinical response to apolizumab varies by genetic subtype of CLL. II. Determine if pharmacokinetic clearance is truly predicted by 1D10 antigen density on the individual patient CLL cell and how apolizumab clearance correlates with response and selected toxicities observed. III. To determine the importance of reactive oxygen species and specific signaling pathways in promoting apolizumab-mediated apoptosis in vitro and in vivo in primary CLL cells and if this correlates with clinical response to therapy. IV. To determine the cellular properties which convey resistance to apolizumab in CLL in vivo. OUTLINE: This is a multicenter study. Patients receive apolizumab IV over 2-4 hours on days 1, 2, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 week, at 1 and 2 months, every 3 months for 1 year, and then every 6 months for 3 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.32 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
Inclusion Criteria: * Histologically confirmed hematologic malignancy of 1 of the following histologies: * Chronic lymphocytic leukemia (CLL) * Small lymphocytic lymphoma (SLL) * Noncontiguous stage II or stage III or IV disease * Received \>= 1 form of prior immunotherapy or chemotherapy * Completed therapy at least 4 weeks ago * Requires therapy (unless early bone marrow transplantation is planned), as indicated by 1 of the following criteria: * Progressively worsening disease (symptoms increasing in severity by 1 toxicity criterion over a period of \>= 2 weeks) * Progressively worsening anemia or thrombocytopenia * Progressively worsening lymphadenopathy * Massive splenomegaly or hypersplenism * Hyperlymphocytosis (WBC \> 200,000/mm\^3) OR lymphocyte doubling time \< 12 months * Marrow failure due to marrow infiltration by leukemia or lymphoma * Leukemia cells must express 1D10 antigen \> 2 times mean fluorescent intensity of the control by flow cytometry of blood or bone marrow cells * Performance status - ECOG 0-2 * At least 2 years * Platelet count \>= 50,000/mm\^3 (transfusion independent) * Bilirubin =\< 3 mg/dL (unless due to tumor involvement) * Creatinine =\< 2.0 mg/dL * No decompensated congestive heart failure * No unstable angina * No myocardial infarction within the past 6 months not corrected by surgery or percutaneous transluminal coronary angioplasty * No active infection requiring oral or IV antibiotics * No other malignancy that limits life expectancy to \< 2 years or that requires active anticancer therapy within 4 weeks of study entry * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months after study treatment * Recovered from prior immunotherapy * More than 3 months since prior alemtuzumab or rituximab * No prior apolizumab * Recovered from prior chemotherapy * More than 4 weeks since prior anticancer hormonal therapy * More than 4 weeks since prior anticancer radiotherapy * More than 4 weeks since prior anticancer surgery * At least 4 weeks since other prior therapy for CLL or SLL and recovered
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
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 2 sites
Ohio State University Medical Center
Columbus, United States