NCT03260101

Non-interventional, Long-term Follow-up of Subjects Who Completed ApoGraft-01 Study

A Non-interventional, Long-term Follow-up of Subjects Who Completed ApoGraft-01 Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 12 (estimated)
• Sponsor: Cellect Biotechnology · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: —

Summary

This is a non-interventional, long-term follow-up study in subjects who received ApoGraft in study ApoGraft-01. Up to 12 subjects who completed ApoGraft-01 study will be offered to participate in this follow-up study. Subjects who completed ApoGraft-01 study and have signed informed consent for this follow-up study will be eligible to enroll. Subject will attend in-clinic visits up to 2 years post transplantation, and will undergo the following evaluations: acute and chronic graft versus host disease (GvHD) assessments, survival status (overall, relapse-free), disease status (disease relapse/recurrence), physical examination, safety laboratory and concomitant medication use.

Conditions

• Acute Myelogenous Leukemia (AML)
• Acute Lymphoblastic Leukemia (ALL)
• Non Hodgkin Lymphoma (NHL)
• Hodgkin Lymphoma, Adult

Interventions

Type	Name	Description
OTHER	non intervational	Subjects who completed ApoGraft-01 study (through 180 days post-transplantation) and have signed informed consent for this follow-up study will be eligible to enroll. Subject will attend 4 in-clinic visits, once every 6 months up to 2 years post transplantation, and will undergo the following evaluations: acute and chronic graft versus host disease (GvHD) assessments, survival status (overall, relapse-free), disease status (disease relapse/recurrence)

Timeline

• Start date: 2018-06-10
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2017-08-24
• Last updated: 2019-11-26

Locations

1 site across 1 country: Israel