AlloLife - Life After Transplantation

Survivorship Clinical Trial

— AlloLife  

Official title:

AlloLife - Life After Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05087784
• Other study ID #: 20210920H
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: June 2026

Study information

• Verified date: November 2021
• Source: University Hospital, Essen
• Contact: Norbert Graf, MD
• Phone: +49- 6841/16-28397
• Email: norbert.graf[@]uks.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Survivors of allo HCT can experience long-term survival, which is however limited by a number of late effects. These will be addressed in AlloLife to improve quality of life (QoL) and survival.

Description:

The complex intervention in AlloLife will consist of a set of technically-supported tools that will enable active care management through the patient and treating physician to improve QoL.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 192
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18

• Patients with performed allogeneic stem cell transplantation any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen and at least at day +20 after HCT.

• Hematologic Remission after HCT at study entrance, MRD positive patients are allowed to enter the study

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-3

• Signature of informed and written consent by the subject or by the subject's legally acceptable representative for patients under guardianship or trusteeship to participate in the study

• Access to an internet connected device (smartphone/tablet/computer)

• Able to understand and communicate in the respective language

• Consent to use a wearable device through the time of the study

• Consent to use a chatbot application for both healthcare data exchange and psychologic intervention

Exclusion Criteria:

• Missing consent to use a wearable device and contribute personal data collected at the point of life to the study

• ECOG performance status of 4

• Relapse of the disease at study inclusion

• Uncontrolled systemic infection

• Diagnosis of a secondary malignancy requiring systemic therapy

• Reported ongoing severe depression or potential suicidal ideation

• Vulnerable patients such as: minor, persons deprived of liberty, persons in Intensive Care Unit unable to provided informed consent prior to the intervention

• Other ongoing interventional protocol that might interfere with the current study primary endpoint

Related Conditions & MeSH terms

• Stem Cell Transplant Complications
• Survivorship

Intervention

Combination Product:
• Technology supported, coordinated survivorship care using wearable devices, supportive patient-apps and cardio-oncology physician apps
Patient-centered, technology-supported integrated survivorship- and care management

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital, Essen	Centre for Research and Technology Hellas, Institut Paoli-Calmettes, Medical University of Warsaw, Universität des Saarlandes, University Of Perugia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life as measured by the FACT-BMT score	Change in QoL measured by the FACT BMT score on a continuous scale. The Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) as initially developed by McQuellon RP et al. BMT 1997. It scales between 0 (zero) and 196 on a continuous scale, where higher values refer to higher Quality of Life.	12 months