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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03260101

Enrollment

Registered

2017-08-24

Start date

2018-06-10

Completion date

2021-12-31

Last updated

2019-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

OTHERnon 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)

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence, grade and stage of acute GvHD and chronic GvHD	18 months	GVHD will be assessed according to NIH criteria 2005; current and maximal score at each visit.

Secondary

Measure	Time frame
Non-relapse-related mortality	18 months
Proportion of subjects with disease relapse/recurrence	18 months
Proportion of subjects with relapse free and overall survival	18 months

Countries

Israel

Contacts

Primary ContactShai Yarkoni, MD

shai@cellect.co972-9-974-1444

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026