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

Cellect Biotechnology

Status: Unknown

Conditions: Hodgkin Lymphoma, Adult; Acute Lymphoblastic Leukemia (ALL); Non Hodgkin Lymphoma (NHL); Acute Myelogenous Leukemia (AML)

Treatments: Other: non intervational

Study type: Observational

Funder types: Industry

Identifiers

NCT03260101

ApoGraft01 FU

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Subjects who completed study ApoGraft-01 through 180 days (6 months) post-transplantation
2. Ability to comply with the requirements of the study.
3. Signed written informed consent

Trial design

12 participants in 1 patient group

one group, ApoGraft Follow up Study

Description:

Non-interventional, long-term follow-up study in subjects who received ApoGraft in study ApoGraft-01

Treatment:

Other: non intervational