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NCT03969446 · ClinicalTrials.gov registry record · Phase 1
Pembrolizumab and Decitabine With or Without Venetoclax in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome That Is Newly-Diagnosed, Recurrent, or Refractory
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT03969446 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 54 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03969446, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase Ib trial studies the side effects and best dose of pembrolizumab and how well it works in combination with decitabine with or without venetoclax in treating patients with acute myeloid leukemia or myelodysplastic syndrome that is newly-diagnosed, has come back (recurrent), or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. This trial may help doctors find the best dose of pembrolizumab that can be safely given in combination with decitabine with or without venetoclax, and to determine what side effects are seen with this treatment.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Venetoclax
- DRUG Decitabine
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2020-05-04 |
| Est. Completion | 2027-07-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03969446
The ClinicalTrials.gov registry entry for NCT03969446 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (53% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03969446 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03969446 about?
NCT03969446 is a clinical study titled "Pembrolizumab and Decitabine With or Without Venetoclax in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome That Is Newly-Diagnosed, Recurrent, or Refractory". This phase Ib trial studies the side effects and best dose of pembrolizumab and how well it works in combination with decitabine with or without venetoclax in treating patients with acute myeloid leukemia or myelodysplastic syndrome that is newly-diagnosed, has come back (recurrent), or does not res...
What is the current status of trial NCT03969446?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2020-05-04. Estimated completion is 2027-07-04.
What conditions does trial NCT03969446 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent Myelodysplastic Syndrome.
What interventions are being tested in trial NCT03969446?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Venetoclax (DRUG), Decitabine (DRUG).
Who is sponsoring clinical trial NCT03969446?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03969446 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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