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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| one group, ApoGraft Follow up Study | Non-interventional, long-term follow-up study in subjects who received ApoGraft in study ApoGraft-01 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Non-relapse-related mortality | 18 months | |
| Proportion of subjects with disease relapse/recurrence | 18 months | |
| Proportion of subjects with relapse free and overall survival |
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Inclusion Criteria:
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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:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shai Yarkoni, MD | Contact | 972-9-974-1444 | shai@cellect.co |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Medical Center | Recruiting | Haifa | Israel |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
|
| 18 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008223 | Lymphoma |