Current Clinical Trials in Acute Myeloid Leukemia

June 14, 2019

Background: Acute myeloid leukemia (AML) is a malignancy of the bone marrow in which development of hematopoietic precursors halts during early stages of marrow formation. Although pre-familial syndromes, existing hematologic disorders, and environmental or drug exposures may be to blame, most patients who present with AML have no identifiable risk factors.[1,2]

Background: Acute myeloid leukemia (AML) is a malignancy of the bone marrow in which development of hematopoietic precursors halts during early stages of marrow formation. Although pre-familial syndromes, existing hematologic disorders, and environmental or drug exposures may be to blame, most patients who present with AML have no identifiable risk factors.[1,2]

Patients with AML experience symptoms stemming from bone marrow failure, infiltration of organs by leukemic cells, or both. Workups to establish diagnosis include blood tests, biopsy and aspiration of bone marrow, and genetic testing.[3-7]

Only a minority of patients with AML respond to chemotherapy, still the leading treatment to date. For this reason, whenever possible, physicians should seek out reputable clinical trials in which to enroll their patients.[8]
Phase III Trials - Recruiting
Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients with Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy ClinicalTrials.gov Identifier: NCT03701308
National Cancer Institute, 121 locations, USA

Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)
ClinicalTrials.gov Identifier: NCT02997202
Astellas Pharma Global Development, Inc, 139 locations, USA

Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients with Down Syndrome
ClinicalTrials.gov Identifier: NCT02521493
Children’s Oncology Group & National Cancer Institute, 173 locations, USA

Tac, Mini-MTX, MMF Versus Tac, MTX for GVHD Prevention
ClinicalTrials.gov Identifier: NCT01951885
University Hospitals Cleveland Medical Center; Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio

Phase II Trials - Recruiting
Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia
ClinicalTrials.gov Identifier: NCT03629171
MD Anderson Cancer Center, Houston, Texas

Cytarabine, Idarubicin, Liposome-encapsulated Daunorubicin-Cytarabine or Decitabine in Treating Older Patients With Acute Myeloid Leukemia
ClinicalTrials.gov Identifier: NCT03226418
University of Nebraska Medical Center, Omaha, Nebraska

Efficacy and Pharmacogenomics of Salvage CLAG-M Chemotherapy in Patients With Relapsed/Refractory and Secondary Acute Myeloid Leukemia
ClinicalTrials.gov Identifier: NCT03150004
Froedtert & the Medical College of Wisconsin, Milwaukee, Wisconsin

Venetoclax and Azacitidine for Non-Elderly Adult Patients With Acute Myeloid Leukemia
ClinicalTrials.gov Identifier: NCT03573024
University of Colorado Hospital, Aurora, Colorado

Fractionated Gemtuzumab Ozogamicin Followed by Non-engraftment Donor Leukocyte Infusions for Relapsed/Refractory Acute Myeloid Leukemia
ClinicalTrials.gov Identifier: NCT03374332
Rhode Island Hospital, Providence, Rhode Island

Phase II Study of the Combination of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin (MEGO) for Patients With Acute Myeloid Leukemia Refractory to Initial Standard Induction Therapy
ClinicalTrials.gov Identifier: NCT03839446
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania

Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients
ClinicalTrials.gov Identifier: NCT02400255
MD Anderson Cancer Center, Houston, Texas

CSF1R Inhibitor JNJ-40346527 in Treating Participants With Relapsed or Refractory Acute Myeloid Leukemia
ClinicalTrials.gov Identifier: NCT03557970
OHSU Knight Cancer Institute, Portland, Oregon, UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas

For Patients With Acute Myeloid Leukemia at High Risk of Relapse After Donor Stem Cell Transplant
ClinicalTrials.gov Identifier: NCT01841333
University of Colorado Cancer Center, Aurora, Colorado, Ohio State University, Columbus, Ohio

Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia
ClinicalTrials.gov Identifier: NCT02583893
Thomas Jefferson University, Philadelphia, Pennsylvania

Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Participants With Previously Untreated Acute Myeloid Leukemia
ClinicalTrials.gov Identifier: NCT03586609
MD Anderson Cancer Center, Houston, Texas

Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Participants With Acute Myeloid Leukemia
ClinicalTrials.gov Identifier: NCT03737955
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington

Daratumumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
ClinicalTrials.gov Identifier: NCT03067571
MD Anderson Cancer Center, Houston, Texas

Azacitidine and Venetoclax as Induction Therapy With Venetoclax Maintenance in the Elderly With AML
ClinicalTrials.gov Identifier: NCT03466294
University of Colorado Cancer Center, Aurora, Colorado

Higher or Lower Dose Cladribine, Cytarabine, and Mitoxantrone in Treating Medically Less Fit Patients With Newly Diagnosed Acute Myeloid Leukemia or Myeloid Neoplasm
ClinicalTrials.gov Identifier: NCT03012672
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington

A Phase II Study of Pembrolizumab as Post-Remission Treatment of Patients ≥ 60 With AML
ClinicalTrials.gov Identifier: NCT02708641
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania

TET2 Mutations in Myelodysplastic Syndromes and Acute Myeloid Leukemia With Azacitidine + Ascorbic Acid
ClinicalTrials.gov Identifier: NCT03397173
Cleveland Clinic, Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio

Allogeneic Transplantation Using Timed Sequential Busulfan, Cladribine, and Fludarabine Conditioning in Patients With Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS)
ClinicalTrials.gov Identifier: NCT02250937
MD Anderson Cancer Center, Houston, Texas

Selinexor With Induction, Consolidation, and Maintenance Therapy in Treating Older Patients With Acute Myeloid Leukemia
ClinicalTrials.gov Identifier: NCT02835222
Comprehensive Cancer Center of Wake Forest University, Winston-Salem, North Carolina

Study of Azacitidine in Combination With Pembrolizumab in Relapsed/Refractory Acute Myeloid Leukemia (AML) Patients and in Newly Diagnosed Older (≥65 Years) AML Patients
ClinicalTrials.gov Identifier: NCT02845297
Johns Hopkins Oncology Center, Baltimore, Maryland, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, Medical University of South Carolina Hollings Cancer Center, Charleston, South Carolina

Pevonedistat and Azacitidine as Maintenance Therapy After Allogeneic Stem Cell Transplantation for Non-Remission AML
ClinicalTrials.gov Identifier: NCT03709576
Penn State Hershey Medical Center: Penn State Cancer Institute, Hershey, Pennsylvania

Stem Cell Transplant to Treat Patients With Favorable or Intermediate Risk Minimal Residual Disease Negative Acute Myeloid Leukemia
ClinicalTrials.gov Identifier: NCT03515707
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington

High Dose Cytarabine Followed by Pembrolizumab in Relapsed/Refractory AML
ClinicalTrials.gov Identifier: NCT02768792
Johns Hopkins School of Medicine, Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina

Pfizer Immunotherapy Combinations for Acute Myeloid Leukemia (AML) Multi-Arm Study 1
ClinicalTrials.gov Identifier: NCT03390296
MD Anderson Cancer Center, Houston, Texas

A Randomized Trial of a Combination of Nintedanib/Placebo in Combination With Induction Chemotherapy for Patients With Refractory or First Relapse Acute Myeloid Leukemia
ClinicalTrials.gov Identifier: NCT02665143
Yale University, New Haven, Connecticut, Vanderbilt Ingram Cancer Center, Nashville, Tennessee

Donor Natural Killer Cells in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
ClinicalTrials.gov Identifier: NCT01787474
MD Anderson Cancer Center, Houston, Texas

References:

1. Arber DA, Orazi A, Hasserjian R, et al. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016;127:2391-405.

2. Taylor J, Xiao W, Abdel-Wahab O. Diagnosis and classification of hematologic malignancies on the basis of genetics. Blood. 2017;130:410-23.

3. Bower H, Andersson TM, Björkholm M, et al. Continued improvement in survival of acute myeloid leukemia patients: an application of the loss in expectation of life. Blood Cancer J. 2016;6:e390.

4. Brownson RC, Chang JC, Davis JR. Cigarette smoking and risk of adult leukemia. Am J Epidemiol. 1991;134:938-41.

5. Gao J, Gentzler RD, Timms AE, et al. Heritable GATA2 mutations associated with familial AML-MDS: a case report and review of literature. J Hematol Oncol. 2014;7:36.

6. Guidugli L, Johnson AK, Alkorta-Aranburu G, et al. Clinical utility of gene panel-based testing for hereditary myelodysplastic syndrome/acute leukemia predisposition syndromes. Leukemia. 2017;31:1226-9.

7. Holme H, Hossain U, Kirwan M, et al. Marked genetic heterogeneity in familial myelodysplasia/acute myeloid leukaemia. Br J Haematol. 2012;158:242-8.

8. Poynter JN, Richardson M, Roesler M, et al. Chemical exposures and risk of acute myeloid leukemia and myelodysplastic syndromes in a population-based study. Int J Cancer. 2017;140:23-33.