Select Clinical Trials Currently Enrolling Patients with Leukemia

January 2018, Vol 8, No 1 - Clinical Trials Tracker


The following clinical trials represent a selection of key studies that are currently recruiting patients with different types of leukemia for inclusion in investigations of new therapies as well as 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 oncologists and other oncology practice providers direct eligible patients to an appropriate clinical trial.

1 CAR T-Cell Therapy for ­Recurrent or Refractory Acute Non–T-Lymphocyte Leukemia

This single-arm, multicenter, phase 2 clinical trial is investigating the safety and efficacy of CD19-targeted chimeric antigen receptor (CAR) T-cell therapy in patients with recurrent or refractory acute non–T-lymphocyte leukemia. Individuals aged 3 to 75 years with an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 may be eligible for enrollment if other criteria are met. Patients will receive CD19-targeted CAR T-cell therapy.

The primary outcome measure is overall efficacy, as defined by the complete remission number plus the number of partial responses divided by the total number of cases being treated. This study plans to enroll 24 patients in China. For more information, e-mail Zhimin Zhai at zzzm889@163.com. The NLM Identifier is NCT02735291.

2 Enasidenib versus Conventional Regimens in Older ­Patients with Late-Stage AML and IDH2 Mutation

This international, multicenter, open-label, randomized phase 3 study compares the efficacy and safety of enasidenib (Idhifa) with conventional care regimens in patients aged ≥60 years with acute myeloid leukemia (AML) and IDH2 mutation that is refractory to or has relapsed after second- or third-line therapy. Men and women with relapsed or refractory AML and IDH2 that was refractory to or has relapsed after a second- or third-line regimen of intensive AML therapy may be eligible for enrollment if other criteria are met. Participants will receive enasidenib plus best supportive care or a conventional regimen.

The primary outcome measure is overall survival (OS). The secondary measures include overall response rate, event-free survival, duration of any time to response, 1-year survival, remission rates, and more. This study expects to enroll 280 patients at multiple locations across the United States and abroad. For more information, call 888-260-1599 or e-mail clinicaltrialdisclosure@celgene.com. The NLM Identifier is NCT02577406.

3 Daunorubicin plus Cytarabine for Untreated AML

This open-label, single-group assignment, phase 2 clinical trial is assessing the suitability of daunorubicin plus cytarabine (Vyxeos) as first intensive therapy in patients aged ≥60 years with AML. Men and women with untreated AML and a Karnofsky performance status of >50% or an ECOG performance status 0 to 2 may be eligible for enrollment if other criteria are met. Patients will receive treatment with daunorubicin plus cytarabine.

The primary outcome measure is the assessment of the feasibility of daunorubicin plus cytarabine as first intensive therapy in patients with AML based on safety and efficacy. The secondary measures are the efficacy of daunorubicin plus cytarabine as first intensive therapy in older patients with AML by bone marrow biopsy determination of treatment response rate, frequency and severity of adverse events, quality of life, cognitive function, and the rate of morphologic leukemia-free state. This study plans to enroll 60 patients at the Weill Cornell Medical College in New York, NY. For more information, contact Ellen K. Ritchie, MD, at 646-962-2700 or ritchie@med.cornell.edu, or Elena Lascu, MA, at 212-746-0974 or ell2028@med.cornell.edu. The NLM Identifier is NCT03335267.

4 Daunorubicin plus Cytarabine in Young Patients with Relapsed Leukemia or Lymphoma

The purpose of this phase 1, open-label, single-group assignment clinical trial is to test the safety of daunorubicin plus cytarabine (Vyxeos) in young patients with relapsed leukemia or lymphoma. Patients aged 12 months to 30 years with AML, acute lymphoblastic leukemia (ALL), or aggressive lymphoma, and with a Karnofsky performance status of ≥50% may be eligible for enrollment if other criteria are met. Patients will receive daunorubicin plus cytarabine treatment.

The primary outcome measures are the rate of dose-limiting toxicities, maximum tolerated dose, and pharmacokinetics. The secondary outcomes measures include tumor measurement and serum levels of biomarkers. This study expects to enroll 30 patients at the Cincinnati Children’s Hospital Medical Center in Ohio. For more information, contact Laura Fossett, MS, at 513-636-2799 or laura.fossett@cchmc.org, or Lori Backus at 513-636-2799 or lori.backus@cchmc.org. The NLM Identifier is NCT01943682.

5 Ibrutinib plus Fludarabine, Cyclophosphamide, and ­Rituximab in Untreated ­Patients with CLL

The purpose of this open-label, single-group assignment, phase 2 clinical trial is to evaluate ibrutinib (Imbruvica) in combination with fludarabine, cyclophosphamide, and rituximab (Rituxan) as a potential treatment option for untreated patients with chronic lymphocytic leukemia (CLL). Patients aged 18 to 65 years with an ECOG performance status ≤1 may be eligible for enrollment if other criteria are met. Patients will receive ibrutinib plus fludarabine, cyclophosphamide, and rituximab.

The primary outcome measure is the rate of minimal residual disease (MRD)-negative complete response 2 months after completing the combination therapy. The secondary outcome measures include the rate of MRD-negative complete response after 3 cycles of the combination therapy, complete response rate, partial response rate, progression-free survival (PFS), OS, time to MRD negativity, number of participants with serious or nonserious adverse events, and the association of established CLL prognostic factors. This study plans to enroll 85 patients at multiple locations across the United States. For more information, contact Matthew Davids, MD, at 617-632-5847 or matthew_davids@dfci.harvard.edu. The NLM Identifier is NCT02251548.

6 Quizartinib with Standard Chemotherapy or As Maintenance Therapy for Newly Diagnosed AML with FLT3-ITD Mutation

This phase 3, randomized, double-blind, placebo-controlled clinical trial compares the efficacy of quizartinib, an oral FLT3-ITD inhibitor, versus placebo with regard to event-free survival in patients with FLT3-ITD mutation–positive AML. Men and women aged 18 to 75 years with newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm and with an ECOG performance status 0 to 2 may be eligible for enrollment if other criteria are met. Patients will receive chemotherapy plus quizartinib or chemotherapy plus placebo.

The primary outcome measure is event-free survival. The secondary outcome measures include OS and remission rates. This study plans to enroll 536 patients at multiple locations across the United States and abroad. For more information, contact the AbbVie Call Center at 847-283-8955. The NLM Identifier is NCT02755597.

7 Midostaurin for Patients with AML and c-KIT or FLT3-ITD Mutation

This open-label, single-group assignment, phase 2 clinical trial will assess the efficacy of the tyrosine kinase inhibitor midostaurin (Rydapt) in c-KIT or FLT3-ITD mutation–positive t(8;21) AML. Men and women aged 18 to 65 years with an ECOG performance status 0 to 2 may be eligible for enrollment if other criteria are met. All patients will receive midostaurin capsules.

The primary outcome measure is event-free survival. The secondary outcome measures include time to relapse, OS, relapse-free survival, morphologic and molecular complete response rate, incidence of adverse events and serious adverse events, molecular diagnostics of markers in peripheral blood or bone marrow, and the cumulative incidence of relapse. This study plans to enroll 18 patients at multiple locations in Germany. For more information, e-mail Christoph Röllig at Christoph.Roellig@uniklinikum-dresden.de, or Annett Haake at Annett.Haake@uniklinikum-dresden.de. The NLM Identifier is NCT01830361.

8 Midostaurin plus Decitabine in Older Patients with Newly Diagnosed AML and FLT3 Mutation

This phase 2, open-label, single-­group assignment clinical trial assesses the efficacy of midostaurin (Rydapt) plus decitabine (Dacogen) in older patients with newly diagnosed FLT3 mutation–positive AML. Men and women aged ≥60 years with untreated, histologically confirmed AML with FLT3-ITD mutation and/or FLT3-TKD mutation may be eligible for enrollment if other criteria are met. All patients will receive deci­tabine plus midostaurin.

The primary outcome measure is the proportion of complete response to therapy. The secondary outcome measures are the duration of complete response, the incidence of adverse events, OS, overall response rate, and PFS. This study expects to enroll 26 patients at the Mayo Clinic in Rochester, MN. For more information, contact the Clinical Trials Referral Office at 855-776-0015. The NLM Identifier is NCT02634827.

9 Blinatumomab versus Standard Chemotherapy in Young Patients with First-Relapse B-Precursor ALL

This randomized, open-label, single-group assignment, phase 3 clinical trial examines the efficacy, safety, and tolerability of blinatumomab (Blincyto) as consolidation therapy versus conventional consolidation chemotherapy in pediatric patients with high-risk first-relapse precursory B-cell ALL. Patients aged ≤17 years with Philadelphia chromosome–negative, high-risk first relapse precursor B-cell ALL may be eligible for enrollment if other criteria are met. Patients will receive blinatumomab or standard consolidation chemotherapy.

The primary outcome measure is event-free survival. The secondary outcome measures are OS, MRD response, adverse events, survival, relapse incidence, the incidence of anti–blinatumomab antibody formation, and population pharmacokinetic analysis. This study plans to enroll 320 patients at multiple locations abroad. For more information, contact the Amgen Call Center at 866-572-6436 or medinfo@amgen.com. The NLM Identifier is NCT02393859.

10 Venetoclax plus Azacitidine versus Azacitidine in Treatment-Naïve ­Patients with AML

The purpose of this randomized, parallel-assignment, phase 3 clinical trial is to investigate whether adding venetoclax (Venclexta) to azacitidine (Vidaza) is more effective than azacitidine monotherapy. Men and women aged 18 to 99 years with a projected life expectancy of ≥12 weeks and with an ECOG performance status 2 or 3 may be eligible for enrollment if other criteria are met. Patients will receive venetoclax followed by azacitidine or placebo followed by azacitidine.

The primary outcome measures are the proportion of participants with complete remission or complete remission with incomplete marrow recovery, and OS. The secondary outcome measures include the change in time to first composite complete remission, event-free survival, and patient-reported outcomes. This study plans to enroll 400 patients at multiple locations across the United States and abroad. For more information, contact the AbbVie Call Center at 847-283-8955 or abbvieclinicaltrials­@abbvie.com. The NLM Identifier is NCT02993523.

11 Venetoclax in Relapsed or Refractory CLL

The purpose of this open-label, single-group assignment, phase 3 clinical trial is to evaluate the efficacy of venetoclax (Venclexta) monotherapy in participants with relapsed or refractory CLL, including those with the 17p deletion or TP53 mutation, or those who have received previous treatment with a B-cell receptor inhibitor. Men and women aged 18 to 99 years with relapsed or refractory CLL who have an ECOG performance status ≤2 may be eligible for enrollment if other criteria are met. Eligible patients will receive venetoclax.

The primary outcome measure is the complete remission rate. The secondary outcome measures are the overall response rate, the duration of overall response, the time to disease progression, PFS, OS, complete response rate, and the rate of MRD. This study expects to enroll 250 patients at multiple locations across the United States and abroad. For more information, contact the AbbVie Call Center at 847-283-8955 or abbvieclinicaltrials@abbvie.com. The NLM Identifier is NCT02756611.

12 Acalabrutinib versus ­Idelalisib plus Rituximab or Bendamustine plus Rituximab in Relapsed or ­Refractory CLL

The purpose of this randomized, parallel-assignment, phase 3 clinical trial is to evaluate the efficacy of acalabrutinib (Calquence) compared with rituximab (Rituxan) in combination with idelalisib (Zydelig) or bendamustine (Treanda) in patients with previously treated CLL. Men and women aged ≥18 years who received ≥1 previous systemic therapies for CLL and have an ECOG performance status 0 to 2 may be eligible for enrollment if other criteria are met. Patients will receive acalabrutinib or the investigator’s choice of rituximab plus ­idelalisib or bendamustine.

The primary outcome measure is independent review committee (IRC)-assessed PFS. The secondary outcome measures are investigator-assessed PFS, investigator- and IRC-assessed overall response rates, OS, patient-reported outcomes, time to next treatment, and investigator- and IRC-assessed durations of response. This study expects to enroll 306 patients at multiple locations across the United States. For more information, contact Julie Stewart at 650-591-2800, extension 167, or Jeannine Madere at 650-591-2800, extension 231. The NLM Identifier is NCT02970318.