- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01246206
Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Patients Undergoing Related Donor HCT
A Phase II Study of Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Related Donor Hematopoietic Cell Transplantation
The primary goal of the study is to determine the incidence and severity of acute Graft versus Host Disease (GVHD) following human leukocyte antigen (HLA) matched related donor Hematopoetic Stem Cell(HSC) transplant in patients with blood related cancers who receive the combination of tacrolimus and Thymoglobulin as GVHD prophylaxis. The investigators also will determine the safety of this combination in the first six months post transplant.
Secondary goals include determining the time to recovery of white blood cells and platelets (engraftment), determining the occurrence of opportunistic infections, defined as infection that occurs in people with weakened immune systems and caused by organisms that do not normally cause disease (fungal infections, pneumocystis carinii pneumonia (PCP), and viral infections), estimating the incidence of chronic GVHD at two years and the overall and disease free survival at two years.
Immune response will be assessed by means of immuno-correlative studies both prior to and at various points after transplant.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Michigan
-
Detroit, Michigan, États-Unis, 48201
- Barbara Ann Karmanos Cancer Institute
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Suitable related donor as determined by the treating physician
- High resolution molecular HLA typing is mandatory for HLA Class I and II
- Diagnosis of hematological malignancy
- Patients with one of the following hematologic malignancies, and felt to be transplant candidates by their treating physician are eligible to enroll on this protocol:
- Non-Hodgkin lymphoma, any complete remission (CR)/partial remission (PR)
- Hodgkin disease, any CR/PR/stable disease (SD)
- Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) any CR; for non-CR AML or ALL, bone marrow blast < 20% within 4 weeks of transplant and peripheral blood (PB) absolute blast count < 500/μl on the day of initiation of conditioning
- Myelodysplastic syndrome (MDS), treated or untreated
- Chronic myelogenous leukemia (CML) in chronic phase or accelerated phase
- Chronic myelomonocytic leukemia (CMML)
- Multiple myeloma, any CR/PR/SD
- Chronic lymphocytic leukemia (CLL) any CR/PR
- Myelofibrosis and other myeloproliferative disorders; bone marrow blasts less than 20 percent within four weeks of transplant and peripheral blood absolute blast counts less than 500 per microliter on the day of initiation of conditioning
- Age >= 18 and able to cooperate with oral medication intake
- Filgrastim (G-CSF) mobilized Peripheral blood stem cells
- Agrees to participate, and informed consent signed
- Karnofsky performance status (KPS) >= 60, Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Creatinine clearance > 60 mL/min
- Ejection fraction > 50%
- Serum bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST) less than 3 X upper limit of normal
- Forced vital capacity (FVC), forced expiratory volume in one second (FEV1) or diffusion capacity of carbon monoxide (DLCO) > 50% predicted
Exclusion Criteria:
- Bone marrow or Ex vivo engineered or processed graft (cluster of differentiation [CD]34+ enrichment, T-cell depletion, etc)
- Patients with documented uncontrolled central nervous system (CNS) disease
- Active donor or recipient serology positive for human immunodeficiency virus (HIV)
- Known contraindication to administration of Tacrolimus or Thymoglobulin
- Active Hepatitis B or C
- Patients with coronary heart disease (recent myocardial infarctions, angina, cardiac stent, or bypass surgery in the last 6 months) need to be cleared with a stress echocardiogram or nuclear myocardial perfusion stress test, and cardiology consult; all other cardiac history will be at the discretion of the Principal Investigator
- Oxygen usage at the time of enrollment
- Patients with clinical ascites
- Women who are pregnant or nursing
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: Tacrolimus and Thymoglobulin
Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis
|
Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or "transplant."
Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.
Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs.
Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1.
Thymoglobulin will be given intravenously over 6 hours.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Incidence of Acute GVHD
Délai: Assessed first 6 months post transplant
|
Cumulative Incidence of grade II-V acute GVHD with relapse or NRM as competing risks
|
Assessed first 6 months post transplant
|
Safety Defined by Serious Adverse Events
Délai: Assessed first 6 months post transplant
|
Counted the number of participants that experienced any type of grade 3 or higher toxicity.
|
Assessed first 6 months post transplant
|
Severity of Acute GVHD
Délai: Assessed first 6 months post transplant
|
Cumulative Incidence of grade III-V acute GVHD with relapse or NRM as competing risks
|
Assessed first 6 months post transplant
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Determine Incidence of Opportunistic Infections
Délai: Followed for up to two years post transplant
|
Followed for up to two years post transplant
|
|
Estimate Incidence of Chronic GVHD at Two Years
Délai: Followed for up to two years post transplant
|
Cumulative Incidence of chronic GVHD with relapse or NRM as competing risks
|
Followed for up to two years post transplant
|
Overall Survival at Two Year,
Délai: Followed for up to two years post transplant
|
Followed for up to two years post transplant
|
|
Determine Time to Engraftment ("G500")
Délai: Followed for up to two years post transplant
|
The number of days until engraftment ("G500")
|
Followed for up to two years post transplant
|
Determine Time to Engraftment ("PLT20")
Délai: Followed for up to two years post transplant
|
The number of days until engraftment ("PLT20")
|
Followed for up to two years post transplant
|
Collaborateurs et enquêteurs
Parrainer
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 (Réel)
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
Autres numéros d'identification d'étude
- WSU 2009-095
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 Tacrolimus and Thymoglobulin
-
hearX GroupUniversity of PretoriaComplété
-
Oregon Health and Science UniversityNational Institute on Aging (NIA)ComplétéDémence | Maladie d'Alzheimer | Membres de la famille | Épuisement professionnel des soignantsÉtats-Unis
-
Dalarna UniversityUppsala University; The Swedish Research CouncilRecrutementDémence | Déficience cognitive légère | Démence mixte | Démence de type Alzheimer | Déficience cognitive subjective | Démence SénileSuède
-
University of Illinois at Urbana-ChampaignInconnueBlessure de chute | Prévention des chutes | Sécurité antichute
-
Samsung ElectronicsComplétéVieilli | Adultes | Moyen-Âge | Âgé, 80 ans et plusCorée, République de
-
Institut du Cancer de Montpellier - Val d'AurelleUniversity Hospital, Clermont-Ferrand; Laboratoire EPSYLON; Academic resource...Complété
-
Eunice Kennedy Shriver National Institute of Child...Inconnue
-
University of Illinois at ChicagoComplétéPersonnes âgées en bonne santéÉtats-Unis
-
Vastra Gotaland RegionDetectivio ABComplété
-
University of South CarolinaActif, ne recrute pasFrénésie alimentaire | L'image corporelle | Comportement alimentaire | Nutrition, Santé | Alimentation désordonnéeÉtats-Unis