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

NCT03260101 | Unknown

• 1 other identifier: ApoGraft01 FU
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence, grade and stage of acute GvHD and chronic GvHD

  GVHD will be assessed according to NIH criteria 2005; current and maximal score at each visit.

  18 months

Secondary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

non intervational OTHER

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)

Also known as: ApoGraft follow up

one group, ApoGraft Follow up Study

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

Sponsors & Collaborators

• Cellect Biotechnology: lead

Study Sites (1)

Rambam Medical Center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Non-Hodgkin; Hodgkin Disease

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma

Central Study Contacts

Shai Yarkoni, MD

CONTACT

972-9-974-1444; shai@cellect.co

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 24, 2017
• Study Start: June 10, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)