Select Clinical Trials Currently Enrolling Patients with Leukemia

July 2017, Vol 7, No 7 - Clinical Trials Tracker


The following clinical trials represent a selection of key studies that are currently recruiting patients with leukemia for inclusion in investigations of new therapies or new regimens of existing treatments for patients with leukemia. Each description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. This information can help oncology practice managers and providers direct eligible patients to an appropriate clinical trial.

1 Guadecitabine versus Treatment Choice for Previously Treated Acute Myeloid Leukemia

The objective of this randomized, parallel-assignment, phase 3 study is to assess the safety and efficacy of guadecitabine (SGI-110) versus a treatment of choice in adults with previously treated acute myeloid leukemia (AML). Individuals aged ≥18 years whose disease relapsed after receiving initial induction therapy with standard intensive chemotherapy and/or who were refractory to initial induction therapy may be eligible for enrollment if other criteria are met. Patients will receive guadecitabine or a treatment of choice, including high-dose cytarabine; low-dose cytarabine, decitabine, or azacitidine; or best supportive care.

The primary outcome measure is overall survival (OS). Secondary outcome measures include event-free survival, long-term survival, number of days alive and out of the hospital, transfusion independent rate, complete response (CR) rate and duration, composite CR, hematopoietic stem-cell transplantation (HSCT) rate, quality of life, and severity. This study plans to enroll 404 patients in New York, Pennsylvania, and Canada. For more information, contact Laksmi Wilson at 925-560-2914 or laksmi.wilson@astx.com, or Harold N. Keer, MD, PhD, at 925-560-2914 or ASTRAL-2@astx.com. The NLM Identifier is NCT02920008.

2 AG-221 versus Conventional Regimens in Older Patients with Late-Stage Acute Myeloid Leukemia and IDH2 Mutation

This randomized, parallel-assignment, phase 3 clinical trial will compare the efficacy and safety of AG-221 versus conventional regimens in older patients aged ≥60 years with AML refractory to or disease that relapsed after second- or third-line AML therapy and who have an IDH2 mutation. Patients with primary or secondary AML and with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 may be eligible to enroll if other criteria are met. Participants will receive AG-221 plus best supportive care or a conventional regimen.

The primary outcome measure is OS. Key secondary outcome measures include overall response rate, event-free survival (EFS), duration of and time to response, overall remission rate, hematologic improvement, HSCT rate, time to treatment failure, and adverse events. This study expects to enroll 280 patients across the United States and abroad. For more information, contact Clinical Trial Disclosure at 888-260-1599 or clinicaltrialdisclosure@celgene.com. The NLM Identifier is NCT02577406.

3 Venetoclax plus Azacitidine versus Azacitidine plus Placebo for Treatment-Naïve Acute Myeloid Leukemia in Patients Ineligible for Induction Therapy

This randomized, parallel-assignment, double-blind, placebo-controlled, phase 3 clinical trial is assessing the safety and efficacy of venetoclax (Venclexta) plus azacitidine (Vidaza) versus azacitidine monotherapy in treatment-naïve patients with AML who are not eligible for standard induction therapy. Patients aged ≥18 years with AML whose projected life expectancy is ≥12 weeks and who are ineligible to receive standard cytarabine and anthracycline induction therapy may be eligible for enrollment if other criteria are met. Eligible patients will receive venetoclax followed by azacitidine or placebo followed by azacitidine.

The primary outcome measure is the proportion of patients with CR or CR with incomplete marrow recovery and OS. The secondary outcome measures are the change in time to first composite CR, EFS, and Patient-Reported Outcomes Measurement Information System Cancer Fatigue Short-Form 7a global fatigue score. This study plans to enroll 400 patients across the United States and abroad. For more information, contact AbbVie_Call Center at 847-283-8955 or abbvieclinicaltrials@abbvie.com. The NLM Identifier is NCT02993523.

4 Blinatumomab for Young Patients with Relapsed B-Cell Acute Lymphoblastic Leukemia

This randomized, parallel-assignment, phase 3 clinical trial is assessing the efficacy of blinatumomab (Blincyto) versus standard combination chemotherapy in patients with relapsed B-cell acute lymphoblastic leukemia (ALL). Patients aged 1 to 30 years with an ECOG performance status score of 0 to 2 and a direct bilirubin <3.0 mg/dL may be eligible for enrollment if other criteria are met. Patients will receive blinatumomab or standard combination chemotherapy.

The primary outcome measures are disease-free survival of patients with high-risk and intermediate-risk relapsed disease, and disease-free survival of patients with late relapsed disease. The secondary outcome measures include OS in patients with high-risk or intermediate-risk relapsed disease and OS in patients with late relapsed disease. This study expects to enroll 598 patients across the United States and abroad. For more information, contact Patrick Brown, MD, at pbrown2@jhmi.edu. The NLM Identifier is NCT02101853.

5 Gilteritinib versus Salvage Chemotherapy in Patients with Relapsed/Refractory Acute Myeloid Leukemia plus FLT3 Mutation

The purpose of this randomized, parallel-assignment, open-label, multicenter, phase 3 clinical trial is to determine the clinical benefit of gilteritinib (ASP2215) therapy versus salvage chemotherapy in patients with FLT3 mutation–positive AML that is refractory to or relapsed after first-line AML therapy. Patients aged ≥18 years with the FLT3 mutation in bone marrow or whole blood and with an ECOG performance status score of ≤2 may be eligible for enrollment if other criteria are met. Eligible patients will receive gilteritinib once daily or salvage chemotherapy.

The primary outcome measure is OS. The secondary outcome measures are EFS, CR, leukemia-free survival, duration of remission, composite CR, transplant rate, and Brief Fatigue Inventory. This study plans to enroll 369 patients across the United States and abroad. For more information, contact Astellas Pharma Global Development at 800-888-7704 ext 5473 or Astellas.registration@astellas.com. The NLM Identifier is NCT02421939.

6 Crenolanib plus Chemotherapy in Patients with Relapsed/Refractory Acute Myeloid Leukemia and Activating FLT3 Mutations

This randomized, parallel-assignment, multicenter, double-blind, phase 3 clinical trial will evaluate the efficacy of crenolanib plus salvage chemotherapy and consolidation, including allogeneic HSCT and ongoing single-agent maintenance, in terms of EFS and OS in patients with relapsed or refractory FLT3 mutation–positive AML. Patients aged ≥18 years who are eligible for intensive chemotherapy and have an ECOG performance status score of ≤2 may be eligible to enroll if other criteria are met. Eligible patients will receive standard chemotherapy plus placebo or chemotherapy plus crenolanib.

The primary outcome measure is EFS and OS. The secondary outcome measures include rates of CR, cumulative incidence of disease relapse or death, quality of life, rate of early death or hypoplastic deaths, and toxicity. This study plans to enroll 276 patients at the Ulm University Hospital in Germany. For more information, contact Hartmut Döhner at hartmut.doehner@uniklinik-ulm.de. The NLM Identifier is NCT02298166.

7 Imatinib versus Dasatinib in Patients with Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia

The purpose of this randomized, parallel-assignment, open-label, phase 3 clinical trial is to establish whether dasatinib (Sprycel) is superior to imatinib (Gleevec) in terms of EFS as first-line therapy for patients with newly diagnosed chronic myeloid leukemia. Patients aged ≥18 years with cytogenetic confirmation of the Philadelphia chromosome or variants of (9;22) translocations and with no evidence of extramedullary leukemic involvement (with the exception of the hepatosplenomegaly) may be eligible for enrollment if other criteria are met. Patients will receive imatinib 400 mg daily or dasatinib 100 mg daily.

The primary outcome measure is 5-year EFS. This study plans to enroll 810 patients at Freeman Hospital in the United Kingdom. For more information, contact Corinne A. Hedgley, BSc, at c.a.hedgley@ncl.ac.uk. The NLM Identifier is NCT01460693.

8 Ublituximab plus Umbralisib versus Obinutuzumab plus Chlorambucil for Chronic Lymphocytic Leukemia

The purpose of this randomized, parallel-assignment, phase 3 clinical trial is to assess the efficacy and safety of ublituximab (TG-1101) plus umbralisib (TGR-1202) compared with obinutuzumab (Gazyva) plus chlorambucil (Leukeran) in patients with chronic lymphocytic leukemia (CLL). Patients aged ≥18 years with treatment-naïve or previously treated CLL and an ECOG performance status score of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will receive ublituximab plus TGR-1202 or obinutuzumab plus chlorambucil.

The primary outcome measure is progression-free survival. The secondary outcome measure is overall response rate. This study plans to enroll 450 patients across the United States and abroad. For more information, contact TG Therapeutics Clinical Support Team at 212-554-4484 or clinicalsupport@tgtxinc.com. The NLM Identifier is NCT02612311.

9 Inotuzumab Ozogamicin and Frontline Chemotherapy in Young Adults with Newly Diagnosed B-Cell Acute Lymphoblastic Leukemia

The purpose of this randomized, parallel-assignment, phase 3 clinical trial is to assess the safety and efficacy of inotuzumab ozogamicin in combination with frontline chemotherapy in patients with newly diagnosed B-cell ALL. Patients aged 18 to 39 years with newly diagnosed CD-22–positive B-cell ALL and an ECOG performance status score of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will receive frontline chemotherapy or frontline chemotherapy plus inotuzumab ozogamicin.

The primary outcome measure is EFS. The secondary outcome measures are disease-free survival, OS, the proportion of patients who achieve CR or any response to induction therapy, overall induction rates, incidence of adverse events, and the proportion of patients who discontinued treatment because of adverse reactions or refused treatment because of lesser toxicities. This study expects to enroll 310 patients at the Alliance for Clinical Trials in Oncology in Boston, MA. For more information, contact J. DeAngelo, MD, PhD, at 617-632-2645 or daniel_deangelo@dfci.harvard.edu. The NLM Identifier is NCT03150693.

10 Vadastuximab Talirine plus Azacitidine or Decitabine in Older Patients with Newly Diagnosed Acute Myeloid Leukemia

This randomized, parallel-assignment, double-blind, phase 3 clinical trial will assess whether vadastuximab talirine combined with azaci­tidine or decitabine (Dacogen) improves remission rates and extends OS compared with placebo combined with azacitidine or decitabine. Patients aged ≥18 years who are eligible for decitabine or azacitidine therapy and have acceptable hematologic and organ function may be eligible to enroll if other criteria are met. Eligible patients will receive vadastuximab talirine plus azacitidine or decitabine or placebo plus azacitidine or decitabine.

The primary outcome measures are OS and composite CR rate. The secondary outcome measures are minimal residual disease–negative composite complete remission rate, duration of remission, EFS, leukemia-free survival, adverse events, laboratory abnormalities, time to response, and mortality rates after first study treatment. This study plans to enroll 540 patients across the United States and abroad. For more information, contact Seattle Genetics Trial Information Support at 866-333-7436 or clinicaltrials@seagen.com. The NLM Identifier is NCT02785900.