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

November 24, 2019 updated by: Cellect Biotechnology

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shai Yarkoni, MD
  • Phone Number: 972-9-974-1444
  • Email: shai@cellect.co

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Up to 12 subjects who completed ApoGraft-01 study will be offered to participate in this follow-up study. Subjects must have had one of the Hemato-Oncology Diseases to enroll into ApoGraft-01:

  • Acute myelogenous leukemia (AML) & Acute lymphoblastic leukemia (ALL)
  • Non-Hodgkin's lymphoma (NHL)
  • Hodgkin's lymphoma (HL)
  • Intermediate, High or Very High risk Myelodysplastic syndrome (MDS)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cellect Biotechnology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 10, 2018

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

August 21, 2017

First Submitted That Met QC Criteria

August 21, 2017

First Posted (ACTUAL)

August 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 26, 2019

Last Update Submitted That Met QC Criteria

November 24, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ApoGraft01 FU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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