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

Acute Lymphoblastic Leukemia (ALL) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03260101
• Other study ID #: ApoGraft01 FU
• Status: Recruiting
• Start date: June 10, 2018
• Est. completion date: December 2021

Study information

• Verified date: November 2019
• Source: Cellect Biotechnology
• Contact: Shai Yarkoni, MD
• Phone: 972-9-974-1444
• Email: shai[@]cellect.co
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia (ALL)
• Acute Myelogenous Leukemia (AML)
• Hodgkin Disease
• Hodgkin Lymphoma, Adult
• Leukemia
• Leukemia, Myeloid, Acute
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non Hodgkin Lymphoma (NHL)
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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)

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Cellect Biotechnology

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Non-relapse-related mortality		18 months
Secondary	Proportion of subjects with disease relapse/recurrence		18 months
Secondary	Proportion of subjects with relapse free and overall survival		18 months