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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: Completed Phase 1 study, sponsored by Duke University.
NCT02046122 is a Phase 1 study that has completed, run by Duke University. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Unacceptable toxicity is defined as: i. Grade III or IV acute GVHD (aGVHD) of the gut or liver or Grade IV aGVHD of the skin lasting \> 7 days; ii. Grade IV Common Terminology Criteria for Adverse Events (CTCAE) toxicity attributable to DLI (e.g. infusion reaction, as opposed to Grade IV CTCAE toxicity from chemotherapy) and lasting \>7 days iii. Treatment-related mortality (TRM)
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 |
What the finished NCT02046122 record still lists
NCT02046122 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Cytarabine is the first listed.
NCT02046122 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02046122's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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