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NCT03613532 · ClinicalTrials.gov registry record · Phase 1
Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN
A Phase 1 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), sponsored by Jacqueline Garcia, MD.
- Active
- Registry status
- Phase 1
- Development phase
- 102
- Enrollment target
- 1
- Study location
NCT03613532 is a Phase 1 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) that is active but no longer recruiting, run by Jacqueline Garcia, MD. The registered enrollment target is 102 participants, below the 142-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (28% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03613532, a Phase 1 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), is active but no longer recruiting, sponsored by Jacqueline Garcia, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 102 participants
- Enrollment target
- 1
- Study location
Study Summary
This clinical trial involves individuals who have been diagnosed with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), or MDS/myeloproliferative neoplasm-unclassifiable (MDS/MPN-unclassifiable) and are planning to have an allogeneic hematopoietic stem cell transplant ("bone marrow transplant"). The goal of this research study is to (1) test the safety of adding the study drug, Venetoclax, to a standard of care conditioning regimen for bone marrow transplantation as a possible means of eliminating residual (left-over) disease prior to transplant, (2) to test the safety of combination Venetoclax and azacitidine as "maintenance therapy" after transplant to possibly prevent disease recurrence and (3) to test the safety of combination Venetoclax and oral decitabine/cedazuridine as "maintenance therapy" after transplant to possibly prevent disease recurrence. * The name of the study drug involved in this study is Venetoclax. * It is expected that about 102 people will take part in this research study.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Fludarabine
- DRUG Busulfan
- DRUG Azacitidine
Study Locations (1)
Massachusetts
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2018-10-24 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03613532
The ClinicalTrials.gov registry entry for NCT03613532 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 142-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (28% lower). The listed sponsor is Jacqueline Garcia, MD, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Acute Myeloid Leukemia (AML) appearing as the primary indexed condition, and to 4 interventions - of which Venetoclax is the first listed.
NCT03613532 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03613532 about?
NCT03613532 is a clinical study titled "Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN". This clinical trial involves individuals who have been diagnosed with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), or MDS/myeloproliferative neoplasm-unclassifiable (MDS/MPN-unclassifiable) and are planning to have an allogeneic hematopoietic ...
What is the current status of trial NCT03613532?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 102 participants. The study started on 2018-10-24. Estimated completion is 2027-03-01.
What conditions does trial NCT03613532 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Hematopoietic Stem Cell Transplant, Chronic Myelomonocytic Leukemia (CMML), MDS/Myeloproliferative Neoplasm-unclassifiable (MDS/MPN-unclassifiable).
What interventions are being tested in trial NCT03613532?
The interventions under investigation include: Venetoclax (DRUG), Fludarabine (DRUG), Busulfan (DRUG), Azacitidine (DRUG).
Who is sponsoring clinical trial NCT03613532?
This trial is sponsored by Jacqueline Garcia, MD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03613532 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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