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

Sponsor

Cellect Biotechnology (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03260101

Collaborator

(none)

Enrollment

Location

41.7

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myelogenous Leukemia (AML) Acute Lymphoblastic Leukemia (ALL) Non Hodgkin Lymphoma (NHL) Hodgkin Lymphoma, Adult	Other: non intervational

Study Design

Study Type:

Observational

Anticipated Enrollment :

12 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 10, 2018

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
one group, ApoGraft Follow up Study Non-interventional, long-term follow-up study in subjects who received ApoGraft in study ApoGraft-01	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) Other Names: ApoGraft follow up

Arm

Intervention/Treatment

one group, ApoGraft Follow up Study

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

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)

Other Names:

ApoGraft follow up

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

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