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NCT02046122 · ClinicalTrials.gov registry record · Phase 1
Adoptive Transfer of Haplo-identical DLI for AML and MDS
A Phase 1 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT02046122 is a Phase 1 study that has completed, run by Duke University. The registered enrollment target is 19 participants.
The verdict
NCT02046122, a Phase 1 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The primary hypothesis is that chemotherapy followed by donor lymphocyte infusion (DLI) from HLA-haploidentical donors is a safe procedure that will not cause Graft versus Host Disease (GVHD) or increased treatment-related mortality. The Investigator further believes that this will improve outcomes of elderly patients with high-risk AML or MDS compared to chemotherapy alone, and that that this benefit will be even greater in donor-recipient pairs that share maternal-fetal microchimerism or non-inherited maternal antigen (NIMA) mismatch. A large part of this trial will include immune function assays as well as assessments of efficacy, toxicity, and GVHD. Because this therapy may be a tolerable alternative to allogeneic hematopoietic stem cell transplantation (alloHSCT) for elderly patients, the Investigator will validate functional measurements (e.g. Comprehensive Geriatric Assessment (CGA)) with biologic correlates (cytokine and genomic profiles) and clinical outcomes.
Interventions
- DRUG Cytarabine
- DRUG Idarubicin
- BIOLOGICAL DLI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2014-07 |
| Est. Completion | 2019-07-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02046122
The ClinicalTrials.gov registry entry for NCT02046122 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Cytarabine is the first listed.
NCT02046122 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02046122 about?
NCT02046122 is a clinical study titled "Adoptive Transfer of Haplo-identical DLI for AML and MDS". The primary hypothesis is that chemotherapy followed by donor lymphocyte infusion (DLI) from HLA-haploidentical donors is a safe procedure that will not cause Graft versus Host Disease (GVHD) or increased treatment-related mortality. The Investigator further believes that this will improve outcomes ...
What is the current status of trial NCT02046122?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2014-07. Estimated completion is 2019-07-31.
What interventions are being tested in trial NCT02046122?
The interventions under investigation include: Cytarabine (DRUG), Idarubicin (DRUG), DLI (BIOLOGICAL).
Who is sponsoring clinical trial NCT02046122?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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