- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07823946
Assesment of Upper Egypt Experience in Autologous Bone Marrow Transplantation of Patients With Hematological Malignancies: A Cohor Study
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Hematological malignancies are a heterogeneous group of neoplastic disorders arising from the bone marrow and lymphoid tissues, including multiple myeloma, Hodgkin lymphoma, non-Hodgkin lymphoma, and selected leukemias. Despite substantial advances in chemotherapy, targeted therapies, and immunotherapy, relapse remains a major cause of treatment failure and disease-related mortality. Autologous hematopoietic stem cell transplantation (ASCT) has become an integral component of treatment for eligible patients by allowing the administration of high-dose chemotherapy followed by reinfusion of the patient's own hematopoietic stem cells to restore bone marrow function, thereby improving disease control and survival outcomes.
ASCT is considered the standard consolidation therapy for transplant-eligible patients with multiple myeloma and an effective salvage treatment for relapsed or refractory Hodgkin lymphoma and selected aggressive non-Hodgkin lymphomas. Advances in stem cell mobilization, cryopreservation techniques, conditioning regimens, antimicrobial prophylaxis, and supportive care have significantly improved engraftment rates while reducing transplant-related morbidity and mortality. However, complications such as febrile neutropenia, severe infections, mucositis, delayed hematopoietic recovery, organ toxicity, and disease relapse continue to adversely affect patient outcomes and quality of life.
Assessment of transplantation outcomes is essential to evaluate the effectiveness and safety of ASCT in routine clinical practice. Several factors, including patient age, disease status at transplantation, performance status, conditioning regimen, CD34⁺ cell dose, and post-transplant complications, may influence survival and treatment success. Therefore, this study aims to assess the clinical outcomes of ASCT and patient satisfaction among patients with hematological malignancies, as well as to identify factors associated with favorable and unfavorable transplant outcomes, thereby contributing to improved patient selection and optimization of transplant strategies.
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
1. Adult patients (≥18 years) with a confirmed diagnosis of a hematological malignancy.
2.Patients undergoing their autologous hematopoietic stem cell transplantation (ASCT).
3-willingness to participate in the study
Exclusion Criteria:
- 1.Patients undergoing allogeneic hematopoietic stem cell transplantation. 2.Patients with uncontrolled active infection or severe organ dysfunction that contraindicates transplantation.
3.Patients with incomplete clinical data or who withdraw consent during the study period.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
Autologous bone marrow transplant patients
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
PFS
Délai: through study completion, an average of 2 year
|
Clinical outcome of autologous hematopoietic stem cell transplantation, including overall survival (OS) and Progression-Free Survival (PFS).
|
through study completion, an average of 2 year
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
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
Autres numéros d'identification d'étude
- Autologous B.M. transplantatio
Informations sur les médicaments et les dispositifs, documents d'étude
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