Roles
- Professor of Clinical Medicine
- Chief, Leukemia Section
-
Biography
Justin M. Watts, M.D., is a Professor of Clinical Medicine in the Division of Hematology at the University of Miami Miller School of Medicine, Chief of the Leukemia Section at Sylvester Comprehensive Cancer Center, and the Pap Corps Endowed Professor in Leukemia. Dr. Watts earned his medical degree from Emory University School of Medicine in 2007 and completed his residency in Internal Medicine at the University of California, San Francisco, in 2010. He subsequently completed fellowship training in Hematology and Medical Oncology at Memorial Sloan Kettering Cancer Center in 2014 before joining the University of Miami.
At Sylvester, Dr. Watts leads a clinical and translational research program focused on acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), and myeloproliferative neoplasms (MPN). His research focuses on developing novel targeted and epigenetic therapies and advancing precision medicine approaches for patients with myeloid malignancies.
Dr. Watts has played a leading role in the clinical development of olutasidenib, a selective IDH1 inhibitor for patients with IDH1-mutated AML. He led its first-in-human clinical trial and contributed to its subsequent clinical development, which led to FDA approval in 2022 for adults with relapsed or refractory AML with a susceptible IDH1 mutation. His research continues to investigate novel therapies and combination strategies designed to improve the durability of treatment responses and patient outcomes.
Dr. Watts has led and participated in numerous early-phase and investigator-initiated clinical trials and has received national research funding for his work. His contributions continue to advance the development of new therapies and precision medicine approaches for patients with leukemia and other myeloid malignancies. His current work focuses on LSD1, menin, and other epigenetic and differentiation therapies in AML, including in the highest risk sub-types: KMT2A-r, MECOM-r, RAS-mutated, and TP53. -
Education & Training
Education
Post Graduate Training
Licensures and Certifications
-
Honors & Awards
-
Research Interests
Dr. Watts’ research focuses on generating new therapeutic options for patients with acute myeloid leukemia and myelodysplastic syndrome. He does this through translational research with laboratory investigators and by designing and conducting early phase clinical trials of novel agents and precision medicine approaches, and by analyzing patients cells in the lab to understand the mechanisms of action. His research specifically focuses on developing epigenetic-targeted therapies for these diseases. -
Publications
Disclaimer: Information presented in this section has been consolidated using AI and machine learning technologies. While every effort has been made to ensure accuracy, errors may occur. If you identify any inaccuracies, use this link to inform our data team. Your feedback is appreciated and helps us improve the quality of our content.Professional Activities
Articles & News
Sylvester Comprehensive Cancer Center at ASH 2025: Advancing Blood Cancer Science Through Collaboration
Sylvester’s Researchers Lead Major Treatment Overhauls For Acute Myeloid Leukemia
Clinical Study on Targeted Drug Expands Treatment Options for Myelodysplastic Syndrome
Disclaimer:
Information presented in this section has been consolidated using AI and machine learning technologies. While every effort has been made to ensure accuracy, errors may occur. If you identify any inaccuracies, use this link to inform our data team. Your feedback is appreciated and helps us improve the quality of our content.
Clinical Trials
Viewing 0 of 33 clinical trials.
-
The purpose of this research study is to test the safety of an investigational drug called PRT12396 in people with polycythemia vera (PV) or myelofibrosis (MF). Researchers will study the drug's side effects and learn how it affects these conditions to help determine the best dose for future studies. PRT12396 has not been approved by the FDA and this is the first time it is being tested in humans.
- Principal Investigator: Justin Watts
- Study Phase: Phase I
- Enrollment Status: Open
-
To determine the safety and tolerability of olutasidenib in combination with cladribine + LDAC venetoclax (Arm 1), gilteritinib venetoclax (Arm 2), and ruxolitinib (Arm 3) for patients with relapsed/refractory IDH1-mutated myeloid malignancies with a co-signaling mutation.To quantify the composite complete remission rate (CRc; CR + CRh + CRi) in patients with relapsed/refractory IDH1-mutated myeloid malignancies with a co-signaling mutation treated with olutasidenib in combination with cladribine + LDAC venetoclax (Arm 1), gilteritinib venetoclax (Arm 2), and ruxolitinib (Arm 3).
- Principal Investigator: Justin Watts
- Study Phase: Phase II
- Enrollment Status: Open
-
Phase 1b: To determine the safety and tolerability and recommended phase 2 dose (RP2D) of decitabine (either IV or oral decitabine/cedazuridine (ASTX727, Inqovi)) and venetoclax in combination with olutasidenib.Phase 2: To determine the complete remission rate (CR) of decitabine (IV or oral decitabine/cedazuridine (ASTX727, Inqovi)) and venetoclax in combination with olutasidenib for newly diagnosed (Arm A) or relapsed/refractory (Arm B) patients with IDH1-mutated myeloid malignancy.
- Principal Investigator: Justin Watts
- Study Phase: Phase I/II
- Enrollment Status: Open
-
A Phase 1, Open-Label, Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms
- Principal Investigator: Justin Watts
- Study Phase: Phase 1
- Enrollment Status: Not Accepting
-
A Multicenter, Open-Label, Pilot Study of Alisertib (MLN8237), a Novel Inhibitor of Aurora Kinase A, in Adult Patients With Relapsed/Refractory Acute Megakaryoblastic Leukemia or Myelofibrosis (Including Primary and Post-Essential/Post-Polycythemic Myelofibrosis)
- Principal Investigator: Justin Watts
- Study Phase: N/A
- Enrollment Status: Closed
-
An Open-Label Phase 1b Study of NEROFE, a Novel Hormone-Peptide in Adult Patients With Advanced Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)
- Principal Investigator: Justin Watts
- Study Phase: Phase 1
- Enrollment Status: Open
-
A Randomized, Open-label, Controlled, Phase 2 Study of Pevonedistat, Venetoclax, and Azacitidine Versus Venetoclax Plus Azacitidine in Adults With Newly Diagnosed Acute Myeloid Leukemia Who Are Unfit for Intensive Chemotherapy
- Principal Investigator: Justin Watts
- Study Phase: Phase 2
- Enrollment Status: Closed
-
Phase 1B/II Study of Escalating Doses of Pevonedistat (TAK-924, Formerly MLN4924) Administered in Combination With Standard Induction Chemotherapy (Cytarabine and Idarubicin) in Newly Diagnosed High Risk Acute Myelogenous Leukemia (AML)
- Principal Investigator: Justin Watts
- Study Phase: Phase 1/Phase 2
- Enrollment Status: Closed
-
A Phase I, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
- Principal Investigator: Justin Watts
- Study Phase: Phase 1
- Enrollment Status: Closed
-
A Phase 3, Randomized, Controlled, Open-label, Clinical Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Low-Blast Acute Myelogenous Leukemia
- Principal Investigator: Justin Watts
- Study Phase: Phase 3
- Enrollment Status: Closed
-
A Phase II Trial of Pevonedistat and Azacitidine in MDS or MDS/MPN Patients Who Fail Primary Therapy With DNA Methyl Transferase Inhibitors
- Principal Investigator: Justin Watts
- Study Phase: Phase 2
- Enrollment Status: Closed
-
An Open-label, Multicenter Phase 1 Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Splicing Modulator H3B-8800 for Subjects With Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia
- Principal Investigator: Justin Watts
- Study Phase: Phase 1
- Enrollment Status: Closed
-
An Open-Label, Dose Escalation, Phase 1 Study of PEVONEDISTAT, a Novel Inhibitor of the NEDD8-Activating Enzyme (NAE), in Combination With Low Dose Cytarabine (LDAC) in Adult Patients With Acute Myelogenous Leukemia (AML) and Advanced Myelodysplastic Syndromes (MDS)
- Principal Investigator: Justin Watts
- Study Phase: Phase 1
- Enrollment Status: Closed
-
Phase 1B Open-Label, Dose-Escalation and Dose-Expansion Study of APVO436 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or High-Grade Myelodysplastic Syndrome (MDS)
- Principal Investigator: Justin Watts
- Study Phase: Phase 1
- Enrollment Status: Closed
-
A Phase I/II Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents in Participants With Myelodysplastic Syndrome and Acute Myeloid Leukaemia
- Principal Investigator: Justin Watts
- Study Phase: Phase 1/Phase 2
- Enrollment Status: Closed
-
To evaluate the safety and tolerability of BH-30236 in adult subjects with R/R AML or HR-MDS and to determine the maximum tolerated dose (MTD)•To identify the recommended doses for expansion (RDEs)
- Principal Investigator: Justin Watts
- Study Phase: Phase I
- Enrollment Status: Open
-
To determine the relationship between clinical response and exposure of APVO436 in combination with venetoclax and azacitidine in patients with newly diagnosed AML.To determine whether the baseline level of leukemia cell CD123 expression correlates with response
- Principal Investigator: Justin Watts
- Study Phase: Phase I/II
- Enrollment Status: Open
-
A Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 in Patients With Myelofibrosis
- Principal Investigator: Justin Watts
- Study Phase: Phase 2
- Enrollment Status: Closed
-
A Phase Ib/IIa Study Evaluating the Safety and Tolerability of Vitamin C in Patients With Intermediate or High Risk Myelodysplastic Syndrome With TET2 Mutations
- Principal Investigator: Justin Watts
- Study Phase: Phase 1/Phase 2
- Enrollment Status: Closed
-
Assess the efficacy of the investigational treatment based on disease remission after inductionAssess the efficacy of the investigational treatment based on overall responseAssess any-cause survivalAssess survival in the absence of treatment failure, hematologic relapse, or progressive disease
- Principal Investigator: Justin Watts
- Study Phase: Phase II
- Enrollment Status: Open
-
To determine the safety of the combination of olutasidenib, venetoclax,and azacitidine (OLU-VEN-AZA) in participants with IDH1m+ AML who are IC-eligible.
- Principal Investigator: Justin Watts
- Study Phase: Phase II
- Enrollment Status: Open
-
To evaluate the effect of ziftomenib combined with SOC ven+aza on patient survival in untreated NPM1-m AMLTo determine the efficacy of ziftomenib combined with SOC ven+aza in untreated NPM1-m AML
- Principal Investigator: Justin Watts
- Study Phase: Phase III
- Enrollment Status: Open
-
A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination With Azacitidine or Cytarabine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome With an IDH1 Mutation
- Principal Investigator: Justin Watts
- Study Phase: Phase 1/Phase 2
- Enrollment Status: Closed
-
The purpose of this phase 2/3 study is to confirm the recommended doses and to evaluate the safety and pharmacodynamics of Calaspargase pegol for the treatment of adult patients with Philadelphia-negative Acute Lymphoblastic Leukemia.
- Principal Investigator: Justin Watts
- Study Phase: Phase II/III
- Enrollment Status: Closed
-
The purpose of this expanded access treatment is to provide experimental treatments to you for the treatment of your MF. Alisertib is an experimental treatment which has not been approved by the FDA for the treatment of MF
- Principal Investigator: Justin Watts
- Study Phase: Phase I
- Enrollment Status: Closed
-
Learn more about combination of venetoclax and azacitidine and how well they work to treat acute myeloid leukemia (AML).
- Principal Investigator: Justin Watts
- Study Phase: Phase II
- Enrollment Status: Closed
-
The purpose of this study is to test the good and bad effects of the drug called venetoclax. Venetoclax could decrease your cancer, but it could also cause side effects, which are described in the risks section below. The study doctors hope to learn if the study drug will cause a beneficial effect or response to your hairy cell leukemia. Venetoclax has already been approved by the FDA to treat other cancers when taken by itself or in combination with other drugs. There will be 6-20 people taking part in this study, depending on eligibility and results.
- Principal Investigator: Justin Watts
- Study Phase: Phase II
- Enrollment Status: Not Accepting
-
A Phase 1/2 Open Label, Multicenter, Dose Escalation and Expansion Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM43239 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
- Principal Investigator: Justin Watts
- Study Phase: Phase 1/Phase 2
- Enrollment Status: Open
-
A Phase 1/2, Open-Label, Dose-Escalation, Dose-Expansion Study of DSP-5336 in Adult Acute Leukemia Patients With and Without Mixed Lineage Leukemia (MLL)-Rearrangement or Nucleophosmin 1 (NPM1) Mutation
- Principal Investigator: Justin Watts
- Study Phase: Phase 1/Phase 2
- Enrollment Status: Open
-
A Phase 2, Open-Label, Single Arm, Multi-Center Study to Assess the Efficacy and Safety of BST-236 as a Single Agent in Adults Unfit for Intensive Chemotherapy With Relapsed or Refractory AML or Higher-Risk Myelodysplastic Syndromes
- Principal Investigator: Justin Watts
- Study Phase: Phase 2
- Enrollment Status: Closed
-
A Phase 2 Multi-Center, Open Label Study to Assess the Safety, Efficacy and Pharmacodynamics of IMG-7289 in Patients With Essential Thrombocythemia
- Principal Investigator: Justin Watts
- Study Phase: Phase 2
- Enrollment Status: Closed
-
The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 alone and in combination with antineoplastic agents in participants with relapsed or refractory acute myeloid leukemia and relapsed or refractory and treatment-naive higher risk melodysplastic syndromes.
- Principal Investigator: Justin Watts
- Study Phase: Phase I
- Enrollment Status: Closed
-
The study is being done to determine if an investigational cancer treatment called ADI-PEG 20 combined with targeted therapy called Venetoclax, a type of cancer treatment that uses drugs to precisely identify and attack certain types of cancer cells and the chemotherapy agent azacitidine are effective in treating Acute Myeloid Leukemia (AML). In addition, the side effects and safety of these treatment combinations will be determined.
- Principal Investigator: Justin Watts
- Study Phase: Phase I
- Enrollment Status: Not Accepting