- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03087929
Follow-up Trial of Rituximab Interferon Transplant Trial: Study Drug-Rituximab and Alpha Interferon
17 mars 2017 mis à jour par: Dr. Neil Berinstein, Sunnybrook Health Sciences Centre
Phase II Follow-up Trial of Rituximab Interferon Transplant Trial: Study Drug-Rituximab and Alpha Interferon
A previous phase II trial entitled Treatment of Follicular non-Hodgkin's Lymphoma with High Dose Therapy and Stem Cell Support Followed by Consolidative Immunotherapy with Rituximab and Alpha Interferon was conducted at the Odette Cancer Centre between 2005 and 2012.
The primary objectives of this previous trial was to assess progression free survival and overall survival.
Of the 36 patients in this trial, approximately 18 remain in remission.
In this new follow up trial, follow up data will prospectively be collected on patients who provide informed consent to do so.
Aperçu de l'étude
Type d'étude
Observationnel
Inscription (Réel)
12
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre, Odette Cancer Centre
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Twelve patients with low grade follicular lymphoma who consented to long term follow-up and were previously treated with high dose therapy and autologous stem cell transplant with rituximab and alpha interferon as part of the phase II trial Treatment of Follicular Non-Hodgkin's Lymphoma with High Dose Therapy and Stem Cell Support Followed by Consolidative Immunotherapy with Rituximab and Alpha Interferon.
La description
Inclusion Criteria:
- Patients with 1-2 relapses of WHO Classification follicle centre NHL grade 1-2/3. Patients must have achieved at least a PR to previous treatment.
- Central pathology review before registration
- Ann Arbor stage III or IV
- Measurable disease: defined as clinically or radiologically documented disease with at least one site bidimensionally measurable using clinical exam, CT or MRI performed in the 3 weeks prior to study enrollment.
- ECOG performance status of <2.
- Patients may have received not more than 1 prior course (4 infusions) of rituximab. Timing from last dose of rituximab must exceed 6 months prior to registration. Patients must have demonstrated at least a PR to rituximab if previously administered.
- Patient consent according to institutional and university human experimentation committee requirements
Adequate Renal, hepatic and hematopoietic function test unless the abnormal values are thought to be due to involvement with lymphoma as defined by:
- Hb> 85
- ANC >1000/mm3
- Platelets >100,000/mm3
- Serum/Total Bilirubin >=2 SI units
- AST/ALT <2x Upper Limit of Normal
Exclusion Criteria:
- Positive serology for HIV
- Uncontrolled Infection
- Pregnancy
- CNS Metastases
- History of Psychiatric Disorder
- Other Malignancy (except nonmelanoma skin cancer)
- Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections), or other conditions, which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
- Major surgery, other than diagnostic surgery, within four weeks.
- Presence of anti-murine antibody (HAMA) reactivity. These laboratory results must be available prior to receiving treatment for those patients
- who have received prior murine proteins or patients who have allergies to murine proteins.
- New York Heart Association Class III or IV heart disease (see Appendix H, Clinical Evaluation of Functional Capacity of Patients with Heart Disease in Relation to Ordinary Physical Activity) or myocardial infarction within the past six months.
- Treatment with an investigational drug within 30 days or five half-lives (of the study drug with the longest half-life) prior to entry into the study, which ever is longer.
- Previous chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of other malignancy except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix within the last 5 years.
- History of allergic reactions to compounds chemically related to Rituximab.
- Refusal to practice contraception if of reproductive potential.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Treatment Arm
Patients who had previously undergone high dose therapy with stem cell support followed by consolidation with Rituximab and alpha-interferon as part of the trial Treatment of Follicular non-Hodgkin's Lymphoma with High Dose Therapy and Stem Cell Support Followed by Consolidative Immunotherapy with Rituximab and Alpha Interferon.
The patients in this arm have consented to long-term follow up.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Overall survival
Délai: through study completion, up to 15 years
|
Number of months from date of enrollment to date of death or last follow-up, whichever comes first.
|
through study completion, up to 15 years
|
Progression-free survival
Délai: through study completion, up to 15 years
|
Number of months from date of enrollment to date of progression.
Progression is defined as a greater than or equal to 50% increase in the sum of the product of measurable lesions.
Appearance of new lesions will also constitute progressive disease.
|
through study completion, up to 15 years
|
Event-free survival
Délai: through study completion, up to 15 years
|
Number of months from date of enrollment to date of an event.
An event is defined as death, disease progression, transformation, or development of secondary malignancy.
|
through study completion, up to 15 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Adverse events possibly or probably related to transplant
Délai: through study completion, up to 15 years
|
Adverse events include second malignancies, myelodysplastic syndrome (MDS), hypogammaglobulinemia, and pulmonary fibrosis.
This outcome measurement is descriptive.
|
through study completion, up to 15 years
|
Minimal Residual Disease
Délai: through study completion, up to 15 years
|
This exploratory endpoint is used to evaluate the detection of recurrent lymphoma in peripheral blood DNA.
It is measured as real-time quantitative polymerase chain reaction (RQ-PCR) and is expressed as a percent of detection per 100,000 cells at each follow-up time point.
|
through study completion, up to 15 years
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Neil Berinstein, MD, Sunnybrook Health Sciences Centre
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
20 septembre 2013
Achèvement primaire (Réel)
15 mars 2017
Achèvement de l'étude (Réel)
15 mars 2017
Dates d'inscription aux études
Première soumission
10 février 2017
Première soumission répondant aux critères de contrôle qualité
17 mars 2017
Première publication (Réel)
23 mars 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
23 mars 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 mars 2017
Dernière vérification
1 mars 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Rituxan INF II
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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 .
Essais cliniques sur Follow up
-
Shannon E. Sauer-ZavalaNational Institute of Mental Health (NIMH)Actif, ne recrute pasTrouble obsessionnel compulsif | Troubles anxieux | Trouble de stress post-traumatiqueÉtats-Unis
-
Shannon E. Sauer-ZavalaComplétéDépression | Trouble obsessionnel compulsif | Troubles anxieux | Trouble de stress post-traumatiqueÉtats-Unis
-
University of MichiganNational Institute on Drug Abuse (NIDA); Brown University; Pennington Biomedical... et autres collaborateursRecrutement
-
air up GmbHCitruslabsRecrutement
-
Johns Hopkins UniversityDonaghue Medical Research FoundationActif, ne recrute pas
-
University of MiamiThe Children's TrustComplétéLa dépression | Troubles anxieuxÉtats-Unis
-
Oregon Health and Science UniversityTexas A&M University; University of North Carolina, GreensboroActif, ne recrute pasActivité physiqueÉtats-Unis
-
Molnlycke Health Care ABRecrutementUlcère du pied diabétique | Plaie; Le pied | Ulcère veineux de la jambe | Blessures | Blessure de peau | Jambe blesséeÉtats-Unis
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...RecrutementMaladie critique | Enfant | Faiblesse acquise en unité de soins intensifs | Ulcère de pression nosocomialeÉtats-Unis
-
Daren K. HeylandNestlé; Queen's UniversityComplété