Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 1 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), sponsored by Jacqueline Garcia, MD.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Determine safe dose and schedule of venetoclax
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 |
What the registry record for NCT03613532 still lists
NCT03613532 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 142-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (28% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Acute Myeloid Leukemia (AML)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03613532's enrollment target sits among peer trials
102 12th of 29 higher than 18 of 29 other Acute Myeloid Leukemia (AML) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia (AML) 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
-
A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)
RECRUITING · Phase 1
-
Niclosamide in Pediatric Patients With Relapsed and Refractory AML
RECRUITING · Phase 1
-
APVO436 Phase 1b/2 Study in Patients With Newly Diagnosed AML
RECRUITING · Phase 1
-
Phase I/II Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Hematological Malignances
RECRUITING · Phase 1
-
A Phase 1 Study of STX-0712 in Patients With Advanced Hematological Malignancies (CMML and AML)
RECRUITING · Phase 1
-
A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia
ACTIVE NOT RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03704662 · 102 participants · NA
Preoperative Fractionated Radiation Therapy Versus Stereotactic Body Radiation Therapy for Resectable or Borderline Resectable, or Locally Advanced Type A Pancreatic Adenocarcinoma
- NCT04174742 · 102 participants
Self Reported Pain in Women While Undergoing Treatment for Non-metastatic Breast Cancer
- NCT04275362 · 102 participants
Gait Analysis of a Lateral-Pivot Design Total Knee Replacement
- NCT04541082 · 102 participants · Phase 1
Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI