Phase I/II

Study Title: A Phase I-II Randomized Trial of a Combination of ­Nintedanib/Placebo in Combination With Induction Chemotherapy for Patients With Refractory or First-Relapse AML

Study Type: Phase I/II/interventional/parallel assignment

Study Sponsor and Collaborators: Yale University, Vanderbilt University

Purpose: To determine if a combination of nintedanib plus induction chemotherapy can be an effective strategy for patients where outcome of relapse/refractory AML is poor.

Primary Outcome Measures: Incidence of treatment-emergent adverse events (phase 1) [time frame: 60 days], complete remission rate (phase 2) [time frame: up to 2 years]

Principal Investigator: Thomas Prebet, Yale Comprehensive Cancer Center; contact Julie Holub, CCRP, (203) 737-8358, julie.holub@yale.edu

ClinicalTrials.gov Identifier: NCT02665143

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Study Title: A Phase Ib/II Clinical Trial of Oral Ciprofloxacin and Etoposide in Subjects With Resistant AML

Study Type: Phase I/II/interventional/single-group assignment

Study Sponsor and Collaborators: University of Florida

Purpose: To establish the maximum tolerated dose of oral ciprofloxacin when given in combination with a fixed dose of oral etoposide in patients with resistant AML, and to determine if the established dose of oral ciprofloxacin in combination with oral etoposide is effective in the treatment of patients with resistant AML.

Primary Outcome Measures: Establish the maximum tolerated dose (MTD) of oral ciprofloxacin when given in combination with a fixed dose of oral etoposide for the treatment of resistant AML [time frame: 1 month]; determine the rate of complete remission following treatment with the MTD of oral ciprofloxacin in combination with oral etoposide for the treatment of resistant AML [time frame: 24 months]

Principal Investigator: Randall Brown, MD, University of Florida; contact Christina Cline, RN, (352) 273-6840, clcline@ufl.edu

ClinicalTrials.gov Identifier: NCT02773732

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Study Title: A Phase I/II Study of Decitabine in Combination With Sequential Rapamycin or Ribavirin in High-Risk AML Patients

Study Type: Phase I/II/interventional/single-group assignment

Study Sponsor and Collaborators: University of Rochester

Purpose: To evaluate the response to chemotherapy with the drug decitabine combined with rapamycin in the treatment of relapsed or refractory AML in patients of all ages and in the treatment of newly diagnosed leukemia in those who are older than 65 when diagnosed.

Primary Outcome Measures: Change in blast percentage in the bone marrow [time frame: 4 weeks]

Principal Investigator: Jane Liesveld, MD, University of Rochester; (585) 275-4099, jane_liesveld@urmc.rochester.edu

ClinicalTrials.gov Identifier: NCT02109744

Phase II

Study Title: A Randomized Phase II Trial to Simultaneously Evaluate Two Schedules of the Histone Deacetylase Inhibitor Entinostat in Combination With 5-Azacitidine (5AC, NSC 102816) in Elderly Patients With AML

Study Type: Phase II/interventional/parallel assignment

Study Sponsor and Collaborators: Case Comprehensive Cancer Center

Purpose: To further examine the combination of 5AC plus entinostat vs 5AC alone in AML and to see how the timing of when 5AC and entinostat are given affects the magnitude of the disease response.

Primary Outcome Measures: To estimate the major response rate in patients with AML who are ≥ 60 years old and unable to tolerate or decline cytotoxic chemotherapy or patients who have relapsed despite one prior regimen; to estimate the overall response rate following treatment in patients with AML ≥ 60 years old who are unable to tolerate or decline cytotoxic chemotherapy or those who have relapsed despite one prior regimen [time frame: up to 15 cycles (420 days)]

Principal Investigator: Hetty Carraway, MD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center; contact Ivana Gojo, MD, (410) 502-7726, igojo1@jhmi.edu

ClinicalTrials.gov Identifier: NCT01305499

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Study Title: Allogeneic Transplantation Using Timed Sequential Busulfan, Cladribine, and Fludarabine Conditioning in Patients With AML and Myelodysplastic Syndrome (MDS)

Study Type: Phase II/interventional/parallel assignment

Study Sponsor and Collaborators: MD Anderson Cancer Center

Purpose: To compare how well two different schedules of giving busulfan with fludarabine and cladribine before a stem cell transplant in patients with AML or MDS may help to control the disease. The safety of this drug combination will also be studied.

Primary Outcome Measures: Progression-free survival [time frame: 6 months]

Principal Investigator: Uday Popat, MD, MD Anderson Cancer Center; (713) 792-8750

ClinicalTrials.gov Identifier: NCT02250937

Phase III

Study Title: A Phase III Randomized Trial for Patients With de Novo AML Using Bortezomib and Sorafenib (NSC# 681239, NSC# 724772) for Patients With High Allelic Ratio FLT3/ITD

Study Type: Phase III/interventional/parallel assignment

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To study how well ­bortezomib and sorafenib tosylate work in treating patients with newly diagnosed AML.

Primary Outcome Measures: Event-free survival [time frame: from the time on study to induction failure, relapse, or death, up to 11 years]

Principal Investigator: Richard Aplenc, MD, PhD, MSCE, Children’s Oncology Group; check clinicaltrials.gov for contact information for 218 participating locations

ClinicalTrials.gov Identifier: NCT01371981 ■

Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.