Clinical trial · Observational
Non-interventional, Long-term Follow-up of Subjects Who Completed ApoGraft-01 Study
A Non-interventional, Long-term Follow-up of Subjects Who Completed ApoGraft-01 Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia (ALL) | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| Acute Myelogenous Leukemia (AML) | Acute Myeloid Leukemia | ALIAS | 0.85 |
| Hodgkin Lymphoma, Adult | Adult Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Non Hodgkin Lymphoma (NHL) | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| non intervational | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- one group, ApoGraft Follow up Study
- description
- Non-interventional, long-term follow-up study in subjects who received ApoGraft in study ApoGraft-01
- interventionNames
- Other: non intervational
Primary outcomes (1)
- measure
- Incidence, grade and stage of acute GvHD and chronic GvHD
- timeFrame
- 18 months
- description
- GVHD will be assessed according to NIH criteria 2005; current and maximal score at each visit.
Secondary outcomes (3)
- measure
- Non-relapse-related mortality
- timeFrame
- 18 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available