- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
Quebec
-
Montreal, Quebec, Canada, H1T 2M4
- Maisonneuve-Rosemont Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: L1 (dose 1.0x10E4 T-cells/kg)
|
Single intravenous infusion
|
Sperimentale: L2 (dose 5.0x10E4 T-cells/kg)
|
Single intravenous infusion
|
Sperimentale: L3 (dose 1.3x10E5 T-cells/kg)
|
Single intravenous infusion
|
Sperimentale: L4 (dose 3.2x10E5 T-cells/kg)
|
Single intravenous infusion
|
Sperimentale: L5 (dose 7.9x10E5 T-cells/kg)
|
Single intravenous infusion
|
Sperimentale: L6 (dose 2.0x10E6 T-cells/kg)
|
Single intravenous infusion
|
Sperimentale: L7 (dose 5.0x10E6 T-cells/kg)
|
Single intravenous infusion
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Dose limiting toxicity, defined as acute graft-versus-host disease grade III or IV
Lasso di tempo: Within 30 days after ATIR infusion
|
Within 30 days after ATIR infusion
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Immune reconstitution
Lasso di tempo: Until 60 months after ATIR infusion
|
Until 60 months after ATIR infusion
|
Rate of disease relapse
Lasso di tempo: Until 60 months after ATIR infusion
|
Until 60 months after ATIR infusion
|
Occurrence and severity of graft-versus-host disease
Lasso di tempo: Until 60 months after ATIR infusion
|
Until 60 months after ATIR infusion
|
Occurrence of adverse drug reactions
Lasso di tempo: Until 18 months after ATIR infusion
|
Until 18 months after ATIR infusion
|
Incidence and severity of infections
Lasso di tempo: Until 18 months after ATIR infusion
|
Until 18 months after ATIR infusion
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Denis-Claude Roy, MD, Maisonneuve-Rosemont Hospital, Montréal, Canada
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CR-GVH-001
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .