- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00510887
Bortezomib (Velcade) With Standard Chemotherapy for Relapsed or Refractory Follicular Lymphoma
A Phase II Study of Bortezomib in Combination With Rituximab, Fludarabine, Mitoxantrone, and Dexamethasone (VR-FND) for Relapsed or Refractory Follicular Lymphoma
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This is a phase II study using the combination of bortezomib, rituximab, fludarabine, mitoxantrone and dexamethasone. The combination will given over a 28 day cycle. In addition each patient will receive Pneumocystis carinii Pneumonia (PCP) prophylaxis with Trimethoprim/sulfamethoxazole (TMP/Sulfa) or equivalent agent. On day 4 the physician has the option of starting granulocyte colony-stimulating factor (GCSF), granulocyte macrophage colony-stimulating factor (GMCSF), or pegylated GCSF.
All patients who receive at least one dose of the drug will be evaluated for toxicity. Patients will be treated with the agent for at least 2 cycles to be considered eligible for evaluation of response. The chemotherapy dosing will continue until there is evidence of disease progression, a second recurrence of unacceptable toxicity, or a maximum of 8 courses of therapy.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
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North Carolina
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Durham, North Carolina, États-Unis, 27710
- Duke University Medical Center
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Diagnosis of grade 1-3 follicular lymphoma with persistent, relapsed, or refractory disease to at least one prior regimen.
- No prior bortezomib therapy.
- Voluntary written informed consent.
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control.
- Male subject agrees to use an acceptable method for contraception for the duration of the study therapy.
- 18 years of age or older.
- aspartate aminotransferase (AST),alanine aminotransferase (ALT), total bilirubin < 3 times the upper limit of normal unless documented by the treating physician to be secondary to underlying lymphoma.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Exclusion Criteria:
- Platelet count of < 50,000 within 14 days before enrollment unless documented by the treating physician to be due to the disease.
- Absolute neutrophil count of < 1000 within 14 days before enrollment unless documented by the treating physician to be due to disease.
- Estimated or measured creatinine clearance of less than 30 ml/min within 14 days before enrollment.
- ≥Grade 2 peripheral neuropathy within 14 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
- Patient has hypersensitivity to boron, mannitol or any drug included in the current protocol.
- Female subject is pregnant or lactating.
- Received other investigational drugs for this disease within 14 days of enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Known HIV+ status.
- Cardiac ejection fraction less than 35% at study entry measured by echocardiogram, Multigated Acquisition (MUGA) or cardiac MRI.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: VR-FND
Bortezomib (VELCADER) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab. Each cycle will be repeated every 28 days for 8 cycles maximum. |
Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle
Autres noms:
Rituximab 375 mg/m2 IV on day 1
Fludarabine 25 mg/m2 IV on days 1,2,3
Mitoxantrone 10 mg/m2 IV on day 2
Autres noms:
Dexamethasone 20 mg orally on days 1,2,3,4,5
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Complete and Partial Response
Délai: 1 year
|
|
1 year
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Duration of Response
Délai: up to 4 years
|
Duration of response is measured from time of treatment to time of disease progression
|
up to 4 years
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Percentage of Subjects Experiencing Progression Free Survival
Délai: up to 2 years
|
Progression free survival is measured from treatment to progression or death, whichever comes first.
Progressive disease is measured as: 50% or greater increase from nadir in the sum of the products (SPD) of any previously identified abnormal node and the appearance of any new lesions during or at the end of treatment.
|
up to 2 years
|
Percentage of Subjects Experiencing Overall Survival
Délai: up to 2 years
|
Overall survival is from the day of enrollment to date of death from any cause.
|
up to 2 years
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Number of Participants With a Grade 3-4 Hematologic Toxicity.
Délai: up to 1 year
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Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s).
Toxicities are to be assessed according to the NCI Common Toxicity Criteria (CTC).
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up to 1 year
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Number of Participants With Neuropathy, Any Grade
Délai: up to 1 year
|
Before each drug dose, the patient will be evaluated for possible toxicities that may have occurred after the previous dose(s).
Toxicities are to be assessed according to the NCI Common Toxicity Criteria (CTC).
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up to 1 year
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système immunitaire
- Tumeurs par type histologique
- Tumeurs
- Troubles lymphoprolifératifs
- Maladies lymphatiques
- Troubles immunoprolifératifs
- Lymphome non hodgkinien
- Lymphome
- Lymphome folliculaire
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents autonomes
- Agents du système nerveux périphérique
- Inhibiteurs d'enzymes
- Analgésiques
- Agents du système sensoriel
- Agents anti-inflammatoires
- Agents antirhumatismaux
- Agents antinéoplasiques
- Facteurs immunologiques
- Antiémétiques
- Agents gastro-intestinaux
- Glucocorticoïdes
- Les hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Agents antinéoplasiques, hormonaux
- Inhibiteurs de la topoisomérase II
- Inhibiteurs de la topoisomérase
- Agents antinéoplasiques immunologiques
- Dexaméthasone
- Rituximab
- Bortézomib
- Fludarabine
- Mitoxantrone
Autres numéros d'identification d'étude
- Pro00008487
- 8785 (DUMC old IRB number)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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