Leukemia Clinical Trials

Leukemia clinical trials can be outstanding treatment options for certain patients. A clinical trial is a carefully controlled research study through which the effectiveness of a newly discovered treatment is compared to that of treatments currently in widespread use. This evaluation process applies to all new treatments; in fact, even the current “gold standard” leukemia therapies were once available exclusively through clinical trials. If a patient qualifies for and participates in a clinical trial, he or she will have an opportunity to be among the first to benefit from a promising new drug, therapy or technique.

How Are Clinical Trials Used to Treat Leukemia?

Leukemia clinical trials may be designed to test the effectiveness of exciting new discoveries that show promise in any of a variety of areas, including:

  • Diagnosing leukemia in its earliest stages
  • Treating various types of leukemia
  • Reducing or eliminating treatment side effects
  • Preventing leukemia recurrence
  • Improving patient outcomes
  • Enhancing patient quality of life

A respected leader in cancer research, Moffitt Cancer Center excels at scientific and translational work, and our highly respected scientists are currently investigating all aspects of the condition through our active clinical trial program. Oftentimes, certain treatment agents are available through leukemia clinical trials at Moffitt years before they are made available for widespread use, and we have opportunities for newly diagnosed patients, relapsed patients and transplant patients. At Moffitt, we are firmly committed to taking our promising new discoveries from bench to bedside as soon as possible. In this way, we are continually improving patient outcomes and enhancing quality of life.

To learn about the leukemia clinical trials that are currently underway at Moffitt, call 1-813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form online. Our experts can help you determine whether you could potentially benefit from participation in one of our trials. We see patients with and without referrals.

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Open Clinical Trials:

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CLINICAL TRIAL 19456

Phase III Randomized Study of Crenolanib versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects with FLT3 Mutated Acute Myeloid Leukemia

Disease Site: Acute Leukemia (ALL, AML), Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 19481

Phase I, Open Label Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCART123 (Allogeneic Engineered T Cells Expressing anti-CD123 Chimeric Antigen Receptor), Administered in Patients with Relapsed/Refractory Acute Myeloid Leukemia

Disease Site: Acute Leukemia (ALL, AML), Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 19742

Phase 1/1b Dose Escalation Study of Minnelide in Relapsed or Refractory Acute Myeloid Leukemia

Disease Site: Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 19862

A Phase 1/1b Safety Study of PRGN-3006 Adoptive Cellular Therapy in Patients with Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndrome

Disease Site: Acute Leukemia (ALL, AML), Myelodysplastic syndrome (MDS), Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 19870

A Phase 1, Multi-center, Open-label Study of IMGN632 Administered Intravenously in Patients with Relapsed/Refractory CD123-positive Acute Myeloid Leukemia and Other CD123-positive Hematologic Malignancies

Disease Site: Acute Leukemia (ALL, AML), Myeloid and Monocytic Leukemia, Other hematologic

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CLINICAL TRIAL 20042

CD8 Depleted, Non-Engrafting, HLA Mismatched Unrelated Donor Lymphocyte Infusion in Patients with MDS and Secondary AML

Disease Site: Acute Leukemia (ALL, AML), Myelodysplastic syndrome (MDS), Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 20287

A Phase 1b/2 Study of IMGN632 as Monotherapy or Combination with Venetoclax and/or Azacitidine for Patients with CD123-Positive Acute Myeloid Leukemia

Disease Site: Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 20305

Phase 1/1b Trial of Donor gamma delta T-cell Infusion for Treatment of Patients with Acute Myeloid Leukemia at High Risk of Relapse after Allogeneic Hematopoietic Stem Cell Transplantation

Disease Site: Leukemia, other, Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 20415

A Phase III, Open-Label, Multicenter, Randomized Study Evaluating The Safety And Efficacy Of Polatuzumab Vedotin In Combination With RituximabI Plus Gemcitabine Plus Oxaliplatin (R-Gemox) Versus R-Gemox Alone In Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Disease Site: Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 20484

A Phase 2 Study of Donor-Derived Multi-Tumor-Associated Antigen Specific T Cells (MT-401) Administered to Patients with Acute Myeloid Leukemia (AML) following Hematopoietic Stem Cell Transplantation

Disease Site: Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 20552

A Phase 1b/2 Study Evaluating the Safety and Efficacy of Canakinumab with Darbepoetin alfa in Patients with Lower-Risk Myelodysplastic Syndromes (MDS) who have Failed Erythropoietin Stimulating Agents (ESA)

Disease Site: Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 20733

A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzomab Ozogamicin (a conjugated anti-CD22 monoclonal antibody) to Frontline Therapy in Young Adults (ages 18-39 years) with Newly Diagnosed Precusor B-cell ALL

Disease Site: Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 20749

A Phase 1, Open Label Dose Escalation Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 in Patients with Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Disease Site: Leukemia, other, Lymphoid Leukemia, Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 20752

A Phase 1 Study of Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated Acute Myeloid Leukemia

Disease Site: Leukemia, other, Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 20877

A Phase Ib /Randomized Phase III Trial of Patients with Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation with Either Orca-T, a T-cell-Depleted Graft with Additional Infusion of Conventional T cells and Regulatory T cells, or Standard-of-Care Allogeneic Graft

Disease Site: Leukemia, other, Lymphoid Leukemia, Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 20923

A Phase I/II Trial of Maintenance Fedratinib to Prevent Post-Transplant Relapse in Myeloproliferative Neoplasms

Disease Site: Leukemia, other, Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 20963

A Phase 2 Study of Fedratinib in Myelodysplastic /Myeloproliferative Neoplasms (MDS/MPNs) and Chronic Neutrophilic Leukemia (CNL)

Disease Site: Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 21057

A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination with Azacitidine in Patients Newly Diagnosed with Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS)

Disease Site: Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 21090

A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) that is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

Disease Site: Myelodysplastic syndrome (MDS), Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 21142

A Phase 1b, Multicenter, Open-label Platform Study of Select Drug Combinations in Adult Patients with Lower Risk (Very Low, Low, or Intermediate Risk) Myelodysplastic Syndrome (CMBG453E12101)

Disease Site: Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 21167

A Phase 1/2 Open-label Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects with Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)

Disease Site: Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 21186

ACCESS: A Multi-Center, Phase II Trial of HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation with Post-Transplantation Cyclophosphamide for Patients with Hematologic Malignancies

Disease Site: Leukemia, other, Lymphoid Leukemia, Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 21248

A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination with Azacitidine versus Physician s Choice of Venetoclax in Combination with Azacitidine or Intensive Chemotherapy in Previously Untreated Patients with TP53 Mutant Acute Myeloid Leukemia

Disease Site: Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 21405

Phase 2, Single Arm Study of Luspatercept for the Treatment of Anemia in lower Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Myelodysplastic Syndromes/Myeloproliferative Neoplasms (MDS/MPN)

Disease Site: Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 21450

A Phase 1/1b Dose Escalation and Expansion of CPX-351 in Combination with Gemtuzumab Ozogamicin in Newly Diagnosed Acute Myeloid Leukemia

Disease Site: Myeloid and Monocytic Leukemia, Acute Leukemia (ALL, AML)

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CLINICAL TRIAL 21756

A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients with Polycythemia Vera

Disease Site: Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 21761

A Phase 1 First-in-Human Dose-escalation and Dose-expansion Study of BMF-219, an Oral Irreversible Menin Inhibitor, in Adult Patients with Acute Leukemia Including Those with an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Disease Site: Lymphoid Leukemia, Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 21778

An Open-Label Phase 1A/1B Dose Escalation and Expansion Cohort Study of SL-172154 (SIRPα-Fc-CD40L) in Combination With Azacitidine or With Azacitidine and Venetoclax for the Treatment of Subjects With Higher-Risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML)

Disease Site: Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 18926

The National Myelodysplastic Syndromes (MDS) Study

Disease Site: Leukemia, other, Lymphoid Leukemia, Multiple Myeloma, Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 20585

Development of a Quality of Life Decision-Making Model for Older Patients with Acute Myeloid Leukemia

Disease Site: Acute Leukemia (ALL, AML), Myeloid and Monocytic Leukemia

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CLINICAL TRIAL 21752

Chimeric Antigen Receptor T-Cell Therapy: Neurocognitive Effects and Patient-Reported Outcomes

Disease Site: Hodgkin's Lymphoma, Leukemia, other, Lymphoid Leukemia, Multiple Myeloma, Myeloid and Monocytic Leukemia, Non-Hodgkin's Lymphoma, Other Hematopoietic

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CLINICAL TRIAL 21561

Assessment of Chimerism and Relapse Post-Bone Marrow / Hematopoietic Cell Transplant (HCT) using ALLOHEME Test (ACROBAT)

Disease Site: Leukemia, other, Lymphoid Leukemia, Myeloid and Monocytic Leukemia

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