Select Ongoing Trials Currently Enrolling Patients with Leukemia

July 2016, Vol 6, No 7 - Clinical Trials Tracker


The following clinical trials represent a selection of key studies currently recruiting patients with leukemia for inclusion in investigations of new therapies and new treatment regimens. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. The information below can help oncology practice managers and providers direct their eligible patients to one of these clinical trials.

1 Duvelisib or Ofatumumab Monotherapy for CLL or SLL

This nonrandomized, open-label, parallel-assignment phase 3 extension clinical trial examines the efficacy of duvelisib monotherapy or ofatumumab monotherapy in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who experienced disease progression after treatment with duvelisib or ofatumumab in Study IPI-145-07. Men and women aged ≥18 years with a diagnosis of active CLL or SLL who meet ≥1 of the International Workshop on Chronic Lymphocytic Leukemia 2008 criteria for requiring treatment, have an ECOG performance status of 0 to 2, and have measurable nodal disease by computed tomography may be eligible for enrollment if other criteria are met. Eligible patients will receive the alternative treatment (duvelisib or ofatumu­mab) from what they received in Study IPI-145-07.

The primary outcome measure is overall response rate (ORR). The secondary outcome measures include treatment-emergent adverse events, duration of response, and progression-free survival (PFS). This study plans to enroll 150 patients at multiple locations across the United States and abroad. For more information, contact Christina Gardell at 617-453-1283 or christina.gardell@infi.com. The NLM Identifier is NCT02049515.

2 Nilotinib with/without Pegylated Interferon for the First-Line Treatment of Chronic-Phase CML

This phase 3, randomized, open-label, parallel-assignment clinical trial compares the efficacy of nilotinib alone versus with pegylated interferon (IFN) alfa-2a. Patients aged 18 to 65 years with chronic-phase chronic myeloid leukemia (CML) and an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive nilotinib alone or with pegylated IFN alfa-2a.

The primary outcome measure is molecular response. Some of the secondary outcome measures include major molecular response, safety, quality of life, event-free survival (EFS), PFS, and overall survival (OS). This study expects to enroll 200 patients in France. For more information, contact Madeleine Etienne, CRA, at madeleine.etienne@chu-lyon.fr. The NLM Identifier is NCT02201459.

3 Acalabrutinib versus Ibrutinib in Previously Treated High-Risk CLL

This randomized, single-blind, parallel-assignment, phase 3 clinical trial is designed to evaluate PFS with acalabrutinib versus with ibrutinib in patients with previously treated CLL. Patients aged ≥18 years with measurable nodal disease as assessed by computed tomography and with an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive acalabrutinib or ibrutinib.

The primary outcome measure is PFS. The secondary outcome measures include the incidence of treatment-emergent grade ≥3 infections, Richter’s transformation, and of atrial fibrillation, and OS. This study plans to enroll 500 patients in Arizona and California. For more information, contact Acerta Pharma at 888-292-9613. The NLM Identifier is NCT02477696.

4 AG-221 versus Conventional Care Regimens in Older Patients with Late-Stage AML plus IDH2 Mutation

This phase 3, multicenter, randomized, parallel-assignment, open-label clinical trial compares the efficacy and safety of AG-221 with conventional care regimens in patients with acute myeloid leukemia (AML) that is refractory to or that has relapsed after second- or third-line AML therapy and is positive for an isocitrate dehydrogenase (IDH2) mutation. Men and women aged ≥60 years with primary or secondary progression of myelodysplastic syndromes, myeloproliferative neoplasms, or therapy-related AML according to World Health Organization (WHO) classification, who received second- or third-line AML therapy may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive AG-221 plus best supportive care or a conventional care regimen.

The primary outcome measure is OS. The secondary outcome measures include ORR, EFS, duration of response, time to response, treatment-related mortality at 30 and 60 days, 1-year survival, overall remission rate, complete remission rate, hematologic improvement rate, rate of hematopoietic stem-cell transplantation, time to treatment failure, adverse events, and EuroQol C30 and EuroQoL Group EQ-5D-5L questionnaire measures. This study expects to enroll 280 patients at multiple locations across the United States and abroad. For more information, contact Associate Director Clinical Trial Disclosure at 888-260-1599 or clinicaltrialdisclosure@celgene.com. The NLM Identifier is NCT02577406.

5 Ibrutinib plus Rituximab versus Fludarabine Phosphate, Cyclophosphamide, and Rituximab for CLL or SLL

This phase 3, randomized, open-label, parallel-assignment clinical trial will compare the efficacy of ibrutinib and rituximab versus that of fludarabine phosphate, cyclophosphamide, and rituximab in patients with untreated CLL or SLL. Men and women aged 18 to 70 years with a diagnosis of CLL or SLL who did not receive previous chemotherapy, Bruton’s tyrosine kinase inhibitor therapy, or monoclonal antibody therapy for CLL or SLL, and who have an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive ibrutinib plus rituximab or a combination of rituximab, fludarabine phosphate, and cyclophosphamide.

The primary outcome measures are change in quality of life as determined by the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) Trial Outcome Index (TOI) and PFS. The secondary outcome measures include adherence to prescriptions, the change in FACT-Leu TOI score from baseline to 3 months, the change in FACT-Leu TOI score from baseline to 6 months, the impact of CLL on quality of life, incidence toxicity, and OS. This study plans to enroll 519 patients at multiple locations across the United States. For more information, contact Tait Shanafelt, MD, at shanafelt.tait@mayo.edu. The NLM Identifier is NCT02048813.

6 Ublituximab plus TGR-1202 versus Obinutuzumab plus Chlorambucil for CLL

This randomized, open-label, parallel-assignment phase 3 clinical trial evaluates the combination of ublituximab and TGR-1202 versus obinutuzumab plus chlorambucil, as well as compared with ublituximab or TGR-1202 alone, in patients with CLL. Men and women aged ≥18 years with treatment-naïve or previously treated CLL requiring treatment, and with an ECOG performance status of 0 to 2, may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive ublituximab plus TGR-1202, obinutuzumab plus chlorambucil, ublituximab alone, or TGR-1202 alone.

The primary outcome measure is PFS, and the secondary outcome measure is ORR. This study plans to enroll 450 patients at multiple locations across the United States. For more information, contact the TG Therapeutics Clinical Support Team at 212-554-4484 or clinicalsupport@tgtxinc.com. The NLM Identifier is NCT02612311.

7 Ublituximab plus Ibrutinib versus Ibrutinib Alone for High-Risk CLL

The purpose of this phase 3, randomized, open-label, parallel-assignment clinical trial is to evaluate the addition of ublituximab to ibrutinib compared with ibrutinib alone in patients with previously treated CLL and high-risk cytogenetic features. Patients aged ≥18 years with previously treated CLL requiring treatment who have ≥1 high-risk cyto­genetic features and an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive ublituximab plus ibrutinib or ibrutinib alone.

The primary outcome measures are ORR and PFS. This study plans to enroll 330 patients at multiple locations across the United States. For more information, contact the TG Therapeutics Clinical Support Team at 212-554-4484 or clinicalsupport@tgtxinc.com. The NLM Identifier is NCT02301156.

8 Intensive Chemotherapy with or without Dasatinib for AML

This phase 3, randomized, open-label, parallel-assignment, multicenter clinical trial is evaluating standard induction therapy and consolidation therapy with or without dasatinib in adults with newly diagnosed core binding factor AML. Women and men aged ≥18 years with core binding factor AML and no previous chemotherapy for leukemia except hydroxyurea for ≤5 days during the diagnostic screening phase may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive standard induction therapy with daunorubicin and cytarabine, as well as consolidation therapy (high-dose cytarabine) with or without dasatinib.

The primary outcome measure is EFS. The secondary outcome measures include the cumulative incidence of relapse, the cumulative incidence of death, OS, relapse-free survival, toxicity, and the pharmacodynamics inhibition of KIT. This study plans to enroll 277 patients at multiple locations in Germany and in Austria. For more information, contact Hartmut Doehner, MD, at hartmut.doehner@uniklinik-ulm.de, or Peter Paschka, MD, at peter.paschka@uniklinik-ulm.de. The NLM Identifier is NCT02013648.

9 Clofarabine versus Daunorubicin Hydrochloride and Cytarabine for Newly Diagnosed ALL

This randomized, open-label, parallel-group assignment phase 3 clinical trial will compare the efficacy of clofarabine with that of daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in patients with newly diagnosed AML. Men and women aged ≥60 years with newly diagnosed AML according to the WHO classification and with an ECOG performance status of 0 to 3 may be eligible for enrollment if other criteria are met. Eligible patients will receive daunorubicin hydrochloride and cytarabine or clofarabine followed by decitabine or observation.

The primary outcome measure is OS. The secondary outcome measures include mortality rate, induction complete response rates, disease-free survival up to 5 years, OS up to 5 years, epidemiologic factors measured according to the Acute Leukemia Epidemiology and Survival in ECOG questionnaire, change in FACT-Leu TOI score from baseline to 30 days after the start of induction therapy, and change in the Functional Assessment of Chronic Illness Therapy-Fatigue score from baseline to 30 days after starting induction therapy. This study plans to enroll 747 patients at multiple locations across the United States and abroad. For more information, contact James Foran, MD, at Foran.James@mayo.edu. The NLM Identifier is NCT02085408.

10 Vincristine Sulfate Liposome in Treatment-Naïve Adults with ALL

The purpose of this phase 3, randomized, double-blind, parallel-assignment clinical trial is to determine whether vincristine sulfate liposome can reduce peripheral neuropathy more than vincristine sulfate, and be as effective as vincristine sulfate in adults with treatment-naïve acute lymphoblastic leukemia (ALL). Men and women aged 18 to 65 years with de novo treatment-naïve ALL diagnosed by bone marrow morphology and with an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive vincristine sulfate liposome or vincristine sulfate.

The primary outcome measures are ORR and the incidence of general peripheral neuropathy. This study plans to enroll 480 patients in China. For more information, contact Ying chang Mi, MD, at 86-10-22-23909999. The NLM Identifier is NCT02072785.

11 Chemotherapy with/without Bortezomib in Newly Diagnosed T-Cell ALL or Stage II-IV T-Lymphoblastic Lymphoma

The purpose of this randomized, open-label, parallel-assignment phase 3 clinical trial is to compare the efficacy of combination chemotherapy when given with or without bortezomib in patients with newly diagnosed T-cell ALL or stage II to stage IV T-cell lymphoblastic lymphoma. Patients aged 2 to 30 years with newly diagnosed T-lymphoblastic leukemia or T-lymphoblastic lymphoma stage II to stage IV may be eligible for enrollment if other criteria are met. Eligible patients will receive combination chemotherapy without bortezomib or combination chemotherapy with bortezomib.

The primary outcome measure is EFS up to 10 years. The secondary outcome measures include cumulative incidence rates, EFS, and incidence of toxicity. This study expects to enroll 1400 patients at multiple locations across the United States and abroad. For more information, contact David T. Teachey, MD, at 215-590-3025. The NLM Identifier is NCT02112916.

12 Blinatumomab versus Standard Chemotherapy in Pediatric Patients with First-Relapse B-Precursor ALL

This phase 3, randomized, open-label, parallel-assignment clinical trial will evaluate EFS after treatment with blinatumomab when compared with standard-of-care chemotherapy for patients with high-risk first-relapse B-precursor ALL. The effect of blinatumomab on OS and on the reduction of minimal residual disease compared with standard-of-care chemotherapy will also be investigated. Patients aged ≤17 years with Philadelphia chromosome–negative high-risk first-relapse B-precursor ALL may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive blinatumomab or conventional consolidation chemotherapy.

The primary outcome measure is EFS. The secondary outcome measures include OS, minimal residual disease response, adverse events, survival, relapse incidence, and the incidence of antiblinatumomab antibody formation. This study expects to enroll 320 patients at multiple locations abroad. For more information, contact Amgen Call Center at 866-572-6436. The NLM Identifier is NCT02393859.