- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00993486
Dose-ranging Study of a Single Administration of T-cell Add-back Depleted of Host Alloreactive Cells in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor
Phase I, Dose-ranging, Open-label, Study of a Single Administration of T-cells Add-back Depleted of Host Alloreactive Cells Using Theralux™ Therapy, Following Haploidentical Peripheral Blood Stem Cell Transplantation Submitted to CD34+ Cell Selection, in Patients With Severe Hematologic Malignancies
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Allogeneic stem cell transplantation is the treatment of choice for many patients with leukemia and other hematologic malignancies. However, a major limitation of this therapy is that for a significant number of patients no fully HLA-matched donor can be found. The application of partially HLA-matched (haploidentical) family donors, who are virtually always available, has some complications. If there is no T-cell add-back it increases the risk for life-threatening infections and disease relapse, while in case of T-cell add-back the risk of graft-versus-host disease is raised.
Kiadis Pharma has developed a method to selectively deplete host alloreactive T-cells through photodynamic therapy, using TH9402 ex vivo. The donor lymphocyte preparation depleted of functional alloreactive T-cells (ATIR) are administered to the patient 4-6 weeks after the stem cell transplant. This method enables early immune reconstitution while preventing graft-versus-host disease.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Lieux d'étude
-
-
Quebec
-
Montreal, Quebec, Canada, H1T 2M4
- Maisonneuve-Rosemont Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Any of the following hematologic malignancies: very high risk leukemia, acute leukemia, chronic myeloid leukemia (CML), lymphoma, multiple myeloma (MM), myelodysplastic syndrome (MDS)
- Incompatibility at two to three loci (HLA-A, B and/or DR) or a single DR locus of the unshared haplotype between the donor and recipient
- Life expectancy of at least 3 months
- Satisfactory performance status (ECOG ≤ 2);
Exclusion Criteria:
- Possibility of performing an allogeneic transplant with an HLA (human leukocyte antigen) matched sibling donor
- Availability of an 6/6 HLA-A, B and DRB1 matched unrelated donor within 2-3 months;
- Pregnancy
- Viral hepatitis (B or C)
- Active serious infectious process
- HIV positivity;
- Systemic dysfunction (cardiac, pulmonary, hepatic and renal) contra-indicating allogeneic stem cell transplantation
- Prior allogeneic transplantation
- Prior autologous transplantation within twelve months of baseline visit
- Any abnormal condition or laboratory result that is considered by the principal investigator capable of altering patient condition or study outcome
- Active central nervous system (CNS) disease at baseline
- Participation in a trial with an investigational agent within 30 days prior to entry in the study
- Malignant cells in circulating peripheral blood (> 25%)
- Other active malignant disease that would severely limit life expectancy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: L1 (dose 1.0x10E4 T-cells/kg)
|
Single intravenous infusion
|
|
Expérimental: L2 (dose 5.0x10E4 T-cells/kg)
|
Single intravenous infusion
|
|
Expérimental: L3 (dose 1.3x10E5 T-cells/kg)
|
Single intravenous infusion
|
|
Expérimental: L4 (dose 3.2x10E5 T-cells/kg)
|
Single intravenous infusion
|
|
Expérimental: L5 (dose 7.9x10E5 T-cells/kg)
|
Single intravenous infusion
|
|
Expérimental: L6 (dose 2.0x10E6 T-cells/kg)
|
Single intravenous infusion
|
|
Expérimental: L7 (dose 5.0x10E6 T-cells/kg)
|
Single intravenous infusion
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Dose limiting toxicity, defined as acute graft-versus-host disease grade III or IV
Délai: Within 30 days after ATIR infusion
|
Within 30 days after ATIR infusion
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Immune reconstitution
Délai: Until 60 months after ATIR infusion
|
Until 60 months after ATIR infusion
|
|
Rate of disease relapse
Délai: Until 60 months after ATIR infusion
|
Until 60 months after ATIR infusion
|
|
Occurrence and severity of graft-versus-host disease
Délai: Until 60 months after ATIR infusion
|
Until 60 months after ATIR infusion
|
|
Occurrence of adverse drug reactions
Délai: Until 18 months after ATIR infusion
|
Until 18 months after ATIR infusion
|
|
Incidence and severity of infections
Délai: Until 18 months after ATIR infusion
|
Until 18 months after ATIR infusion
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Denis-Claude Roy, MD, Maisonneuve-Rosemont Hospital, Montréal, Canada
Publications et liens utiles
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
Autres numéros d'identification d'étude
- CR-GVH-001
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