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

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

• Registration Number: NCT03260101
• Lead Sponsor: Cellect Biotechnology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-21
• Study First Submitted QC: 2017-08-21
• Study First Posted: 2017-08-24
• Study Start: 2018-06-10
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-24
• Last Update Posted: 2019-11-26
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel