Phase II Trial Of BL22 Immunotoxin In Hairy Cell Leukemia
BL22
Maladies Hématologiques+6
+ Maladies du Système Immunitaire
+ Troubles immunoprolifératifs
Étude thérapeutique
Résumé
Date de début de l'étude : 1 octobre 2003
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Determine the response rate in patients with cladribine-resistant hairy cell leukemia treated with BL22 immunotoxin. Secondary * Determine the response duration in patients treated with this drug. * Determine the safety of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. * Correlate BL22 blood levels and toxicity of this drug with the development of neutralizing antibodies in these patients. OUTLINE: Patients receive BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 followed by rest. Patients are then evaluated at 8 weeks. Patients achieving complete hematologic remission are followed. All other patients continue to receive BL22 immunotoxin as above on days 1, 3, and 5. Treatment repeats every 4 weeks for up to a total of 16 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR without minimal residual disease (MRD) receive 2 courses beyond CR. Patients achieving CR with MRD receive 4 courses beyond CR. Patients are followed every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 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.36 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: * Histologically confirmed hairy cell leukemia * CD22-positive disease by fluorescence-activated cell sorting with anti-CD22 antibody * Meets at least 1 of the following indications for treatment: * Absolute neutrophil count less than 1,000/mm\^3 * Hemoglobin less than 10 g/dL * Platelet count less than 100,000/mm\^3 * Absolute lymphocyte count greater than 20,000/mm\^3 * Symptomatic splenomegaly * Meets 1 of the following response criteria: * No response * Complete response (CR) or partial response (PR) less than 2 years in duration after the last course of prior cladribine * CR or PR less than 4 years in duration after a second or later course of prior cladribine PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * AST and ALT no greater than 2.5 times upper limit of normal (ULN) * Bilirubin no greater than 2.2 mg/dL * Albumin at least 3.0 g/dL Renal * Creatinine no greater than 1.4 mg/dL OR * Creatinine clearance at least 50 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No serum that neutralizes more than 75% of the activity of 1 µg/mL of BL22 immunotoxin using a bioassay * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No other concurrent uncontrolled illness that would preclude study participation * Understand and give informed consent PRIOR CONCURRENT THERAPY: Biologic therapy * No prior BL22 immunotoxin * More than 12 weeks since prior monoclonal antibody therapy Chemotherapy * See Disease Characteristics * More than 4 weeks since prior systemic cytotoxic chemotherapy Endocrine therapy * More than 4 weeks since prior systemic steroids (except stable doses of prednisone no greater than 20 mg/day) Radiotherapy * Not specified Surgery * Not specified Other * No other concurrent investigational agents
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 1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, United StatesVoir le site