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NCT02684162 · ClinicalTrials.gov registry record · Phase 2
Guadecitabine and Donor Lymphocyte Infusion in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Relapsing After Allogeneic Stem Cell Transplant
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT02684162: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT02684162 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02684162, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study Summary
This phase IIa trial studies how well guadecitabine works in treating patients with acute myelogenous leukemia and myelodysplastic syndrome that has returned after a period of improvement after allogeneic stem cell transplant. Guadecitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving guadecitabine before the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
Primary Outcome
Complete remission (CR): Bone marrow with \</= 5% bone marrow blasts with normal maturation of all cell lines in the absence of extramedullary disease in addition to a peripheral blood granulocyte count \>/= 1 X 10\^9/L and a platelet count \>/= 100 x 10\^9 /L.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Guadecitabine
- BIOLOGICAL Donor Lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2016-06-22 |
| Est. Completion | 2024-10-08 |
| Phase | Phase 2 |
What the finished NCT02684162 record still lists
NCT02684162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02684162 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02684162 about?
NCT02684162 is a clinical study titled "Guadecitabine and Donor Lymphocyte Infusion in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Relapsing After Allogeneic Stem Cell Transplant". This phase IIa trial studies how well guadecitabine works in treating patients with acute myelogenous leukemia and myelodysplastic syndrome that has returned after a period of improvement after allogeneic stem cell transplant. Guadecitabine may stop the growth of cancer cells by blocking some of the...
What is the current status of trial NCT02684162?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2016-06-22. Estimated completion is 2024-10-08.
What interventions are being tested in trial NCT02684162?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Guadecitabine (DRUG), Donor Lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT02684162?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02684162's enrollment target sits among peer trials
55 1153rd of 2000 higher than 841 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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