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 Type
OBSERVATIONAL
Enrollment
12
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)
Rambam Medical Center
Haifa, Israel
RECRUITINGIncidence, 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.
Time frame: 18 months
Non-relapse-related mortality
Time frame: 18 months
Proportion of subjects with disease relapse/recurrence
Time frame: 18 months
Proportion of subjects with relapse free and overall survival
Time frame: 18 months
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