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NCT03874052 · ClinicalTrials.gov registry record · Phase 1
Ruxolitinib in Combination With Venetoclax With and Without Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, sponsored by Jennifer Saultz.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
- 3
- Study locations
NCT03874052 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia that is actively recruiting participants, run by Jennifer Saultz. The registered enrollment target is 51 participants, roughly in line with the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target. The trial reports 3 study locations across 3 states.
The verdict
NCT03874052, a Phase 1 study of Refractory Acute Myeloid Leukemia and Recurrent Acute Myeloid Leukemia, is actively recruiting participants, sponsored by Jennifer Saultz.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of ruxolitinib when given together with venetoclax and compares the effect of ruxolitinib in combination with venetoclax to venetoclax and azacitidine in treating patients with acute myeloid leukemia (AML) that has come back (relapsed) or has not responded to treatment (refractory). Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Azacitidine stops cells from making deoxyribonucleic acid and may kill cancer cells. It is a type of antimetabolite. 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. Giving ruxolitinib in combination with venetoclax and azacitidine may be safe, tolerable, and/or effective compare to ruxolitinib with venetoclax in treating patients with relapsed or refractory AML.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Echocardiography Test
- DRUG Azacitidine
Study Locations (3)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Oregon
- OHSU Knight Cancer Institute - Portland
Texas
- UT Southwestern/Simmons Cancer Center-Dallas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2019-08-16 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03874052
The ClinicalTrials.gov registry entry for NCT03874052 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target. The listed sponsor is Jennifer Saultz, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT03874052 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Ohio, Oregon, Texas.
Frequently Asked Questions
What is clinical trial NCT03874052 about?
NCT03874052 is a clinical study titled "Ruxolitinib in Combination With Venetoclax With and Without Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia". This phase I trial studies the side effects and best dose of ruxolitinib when given together with venetoclax and compares the effect of ruxolitinib in combination with venetoclax to venetoclax and azacitidine in treating patients with acute myeloid leukemia (AML) that has come back (relapsed) or has...
What is the current status of trial NCT03874052?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2019-08-16. Estimated completion is 2027-12-31.
What conditions does trial NCT03874052 study?
This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Recurrent Secondary Acute Myeloid Leukemia, Refractory Secondary Acute Myeloid Leukemia.
What interventions are being tested in trial NCT03874052?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Echocardiography Test (PROCEDURE), Azacitidine (DRUG).
Who is sponsoring clinical trial NCT03874052?
This trial is sponsored by Jennifer Saultz, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03874052 being conducted?
This trial has 3 study locations across Ohio, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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