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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 is a Phase 1 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 10 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02996474
The ClinicalTrials.gov registry entry for NCT02996474 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT02996474 reports 0 study locations.
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.
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