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NCT02996474 · ClinicalTrials.gov registry record · Phase 1
Pembrolizumab and Decitabine for Refractory or Relapsed Acute Myeloid Leukemia
A Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT02996474: Completed Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT02996474 is a Phase 1 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02996474, a Phase 1 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
Background: Acute myeloid leukemia (AML) is a cancer of the white blood cells. It is fatal if not treated. Treatment for AML that has not responded to treatment (refractory) or has returned after treatment (relapsed) often do not work. Researchers want to see if an immunotherapy drug, combined with a less intense chemotherapy, may be able to help. Objective: To test if pembrolizumab, in combination with decitabine, is a possible treatment for people with relapsed or refractory AML. Eligibility: Adults 18 years of age and older with refractory AML or relapsed AML. Design: Participants will be first screened for eligibility. The study is counted in 21-day cycles. The initial phase of the study consists of 8 cycles. Participants may be in the study for up to 2 years if they are responding to the treatment. The first 3 weeks of treatment is usually done in the hospital. The rest may be done as an outpatient. Participants will get pembrolizumab at the beginning of each cycle through an IV. Participants will usually get decitabine by IV on days 8 12 and days 15 19 of every other cycle. Participants will give blood samples. Participants will have bone marrow exams. A needle will be inserted into the hip to extract cells from the bone marrow. Some participants may give a sample of saliva from the inside of their cheek. Some participants may give a small skin sample. The top layer of the skin is removed. Some patients may require leukapheresis before starting treatment. This is a procedure to remove leukemia cells in the blood stream.
Primary Outcome
The number of patients who could be treated with a novel combination of Pembrolizumab and Decitabine in relapsed/refractory Acute Myeloid Leukemia participants without being removed from the protocol due to treatment related toxicities.
Interventions
- DRUG Pembrolizumab
- DRUG Decitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2016-12-16 |
| Est. Completion | 2019-04-02 |
| Phase | Phase 1 |
What the finished NCT02996474 record still lists
NCT02996474 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT02996474 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02996474 about?
NCT02996474 is a clinical study titled "Pembrolizumab and Decitabine for Refractory or Relapsed Acute Myeloid Leukemia". Background: Acute myeloid leukemia (AML) is a cancer of the white blood cells. It is fatal if not treated. Treatment for AML that has not responded to treatment (refractory) or has returned after treatment (relapsed) often do not work. Researchers want to see if an immunotherapy drug, combined with...
What is the current status of trial NCT02996474?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2016-12-16. Estimated completion is 2019-04-02.
What interventions are being tested in trial NCT02996474?
The interventions under investigation include: Pembrolizumab (DRUG), Decitabine (DRUG).
Who is sponsoring clinical trial NCT02996474?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02996474's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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