New Clinical Trials Under Way

The following clinical trials are currently recruiting patients with acute myeloid leukemia (AML) for inclusion in several investigations. Each trial description includes the NLM Identifier to use as reference with ClinicalTrials.gov.

Safety Study of SGN-CD33A

The objective of this phase 1, nonrandomized, open-label study is to find the maximum tolerated dose of SGN-CD33A, administered as a single agent and in combination with a hypomethylating agent (HMA) in patients with AML. Patients aged ?18 years who are positive for CD33 and have an Eastern Cooperative Oncology Group performance status of 0 or 1 as well as adequate baseline renal and hepatic function may enroll if other criteria are met. Patients are given the experimental drug intravenously on day 1 or days 1 and 4 every 3 weeks with or without an HMA.

The primary outcome measure is the incidence of adverse events and laboratory abnormalities. The antileukemia activity and pharmacokinetic profile of the drug will be examined. Secondary outcomes include blood concentrations of SGN-CD33A and metabolites, incidence of antitherapeutic antibodies, and remission and survival data. This study is expected to enroll 225 patients in many locations across the United States.

For more information, contact Terri Lowe at 866-333-7436 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01902329.

Decitabine, Cytarabine, and Daunorubicin Hydrochloride

This phase 2, randomized, open-label trial assesses the efficacy of decitabine when given in combination with daunorubicin hydrochloride and cytarabine. Patients aged 18 to 65 years who are diagnosed with AML, have specific karyotypes, and have adequate cardiac function may enroll if other criteria are met. Patients will receive 1-hour intravenous daunorubicin hydrochloride and cytarabine with or without intravenous decitabine 5 days prior to induction of chemotherapy. Patients who do not achieve complete remission after the first cycle will receive a second, identical induction course.

Primary and secondary outcome measures are complete remission rates after 1 and 2 courses of decitabine-primed induction of chemotherapy, respectively. Survival is measured for overall, relapse-free, and event-free rates. This trial is expected to enroll 180 patients and is conducted at academic hospitals in Maine, New York, and Ohio.

For more information, contact Joseph Scandura, MD, at 212-746-1848 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01627041.

Phase 1 Study of IGN523

The main purpose of this phase 1 study is to determine the maximum tolerated dose of intravenous IGN523 in patients with AML. A recommended dose for the phase 2 trial will be identified based on the resulting safety, pharmacokinetic, and clinical data. Patients aged ?18 years with relapsed or refractory disease, Eastern Cooperative Oncology Group performance status of 0 to 2, life expectancy of ?12 weeks, and adequate baseline renal and hepatic function may qualify for enrollment if other criteria are met. Patients will receive the experimental drug intravenously every week for 8 weeks. Patients who meet the criteria for ongoing clinical benefit and acceptable safety will be permitted to receive dosing beyond 8 weeks.

The primary outcome is the incidence of adverse events throughout 1 month after the last dose. The secondary outcomes measure the incidence of antidrug antibodies to IGN523, the concentration of the drug in the blood, and IGN523’s antileukemic activity. Preliminary assessments for biological markers of antileukemic activity are collected. This study is expected to enroll 50 patients in California, Georgia, Indiana, Michigan, Texas, and Washington.

For more information, contact William Ho, MD, PhD, at This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT02040506.

Oral Sapacitabine in Elderly Patients

The purpose of this randomized, open-label, phase 3 study is to assess the efficacy of 2 initial treatment regimens in elderly patients who are not recommended to receive the standard treatment. Patients aged ?70 years with adequate renal and liver function who are newly diagnosed with AML may qualify if other criteria are met, and are randomized to receive decitabine alone or in alternating cycles with sapacitabine.

The primary outcome is over­all survival, and the secondary outcomes measure various remission statuses, hematologic improvement, and disease duration. Patients are followed for up to 43 months. This study plans to enroll 485 patients in many locations across the United States.

For more information, contact Judy H. Chiao, MD, at 908-517-7330 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT01303796.

S0919 Idarubicin, Cytarabine, and Pravastatin

This phase 2, open-label, single-­group assignment trial studies the efficacy of the combination of idarubicin and cytarabine with pravastatin in treating patients with relapsed AML. Patients aged ?18 years who have relapsed ?3 months after receiving ?1 previous chemotherapy regimens for AML, with an ejection fraction ?45% by echocardiogram or MUGA scan, and AST, ALT, and total bilirubin within the required range may qualify if other study criteria are met. Concurrent enrollment in the research study SWOG-9007 is required.

The primary objectives include complete remission rate, relapse-free survival, and overall survival. A toxicity profile and association between prestudy cytogenetic features and response are studied. The study plans to enroll 110 patients at multiple locations across the United States.

For more information, call 210-614-8808 to reach Sandi J. Fredette at extension 1002 or This email address is being protected from spambots. You need JavaScript enabled to view it., or Dana Sparks, MAT, at extension 1004 or dsparks@­swog.org. The NLM Identifier is NCT00840177.

Oral Azacitidine Plus Best Supportive Care

The objective of this phase 3, randomized, double-blind study is to compare the efficacy and safety of best supportive care with or without oral azacitidine as maintenance therapy in patients with AML. Patients aged ?55 years who have achieved their first complete remission—or complete remission with incomplete blood count recovery—within 90 days of receiving their induction chemotherapy may enroll if other criteria are met. Oral azacitidine 300 mg or placebo will be given for the first 14 days of each 28-day treatment cycle. The results are collected over the course of 60 months.

The primary outcome is the overall survival rate, measured as the number of patients who survive. The secondary outcomes include relapse-free survival, complete remission, and the safety and tolerability of the treatment. Healthcare resource utilization and health-related quality­of-life data are also collected. The study is expected to enroll 460 patients in multiple locations across the United States.

For more information, contact Andrew Dorman at 908-673-2076 or adorman@­celgene.com. The NLM Identifier is NCT01757535.

Phase 1b Study of AMG 232 ± Trametinib

This is a phase 1b, open-­label, sequential dose escalation and ex­­pansion study of AMG 232. Patients aged ?18 years with AML that is relapsed or refractory to standard therapy, and who have adequate hematologic, renal, hepatic, and coagulation laboratory assessments are eligible if other criteria are met. Patients will receive oral AMG 232 in escalating doses with or without a fixed dose of oral trametinib.

The primary outcome measures are to evaluate the safety and tolerability, characterize the pharmacokinetics, and determine the maximum tolerated dose of AMG 232 with or without trametinib. Treatment response, measured as complete response, complete response with incomplete recovery, and duration response are the secondary outcome measures. This study is expected to enroll 130 patients in Alabama, New York, Utah, and Washington.

For more information, contact the Amgen Call Center at 866-572-6436 or www.amgentrials.com/amgen/study.aspx. The NLM Identifier is NCT02016729.

Clofarabine with Cytarabine Versus Conventional Induction Therapy and NK Cell Transplantation

The objective of this phase 3, randomized, open-label study is to assess the feasibility and efficacy of haploidentical natural killer (NK) cell transplantation in patients with standard-risk AML, examine the efficacy of clofarabine and cytarabine (Clo/AraC) in patients newly diagnosed with AML, and use minimum residual disease–adapted therapy and further improvements in supportive care to optimize therapy. Patients aged ?21 years who were previously untreated except for hyperleukocytosis may enroll if other criteria are met. Patients will be randomized to receive a regimen of cytarabine, daunorubicin, and etoposide, or Clo/AraC.

The primary outcome measure is to compare the immunologic complete response rate after 1 course of therapy. The secondary outcome measures evaluate the event-free ­survival of standard-risk patients who receive chemotherapy alone versus chemotherapy followed by NK cell transplantation, and results are collected for 3 years after the patient completes therapy. This study is expected to enroll 270 patients in multiple sites across the United States.

For more information, contact Jeffrey Rubnitz, MD, at 866-278-5833 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM Identifier is NCT00703820.

Selinexor in Older Patients

This phase 2, randomized, open-label study compares oral Selinexor to a physician’s choice of 3 conventional-care regimens. Patients aged ?60 years with relapsed or refractory AML of any type except for M3, an Eastern Cooperative Oncology Group performance status of ?2, and only 1 line of previous chemotherapy given at standard doses may qualify if other criteria are met. Patients will receive the experimental drug twice weekly, with doses based on the patient’s body surface area. The patients randomized to the physician’s choice group will receive 1 of the following: (1) best supportive care, (2) best supportive care and a subcutaneous injection of cytarabine 20 mg, or (3) best supportive care with a subcutaneous injection of azacitidine or decitabine. Treatment will continue until the occurrence of disease progression, patient death, or treatment intolerance.

The primary outcome is overall survival, from randomization date until the participant’s death or when the study ends (after about 104 weeks). The secondary outcome is the patient’s survival status 3 months after randomization. This study is expected to enroll 150 patients in multiple locations across the United States.

For more information, contact the primary investigators for each site listed at ClinicalTrials.gov. The NLM Identifier is NCT02088541.

Quizartinib Monotherapy Versus Salvage Chemotherapy

The primary objective of this phase 3, open-label, parallel assignment study is to determine whether quizartinib monotherapy extends overall survival when compared with salvage chemotherapy. Patients aged ?18 years with FMS-like tyrosine kinase 3–Internal Tandem Duplication–positive AML who are refractory to or relapsed within 6 months of their first-line AML therapy may enroll if other eligibility criteria are met. Patients will be randomized to receive either quizartinib 20 or 30 mg, or a cytarabine-based salvage chemotherapy regimen, and are followed for 2 years.

The primary outcome is overall survival rate in each group. Secondary outcomes measure event-free ­survival rates between the 2 treatment groups. This study is expected ­to enroll 326 patients in locations across the United States.

For more information, contact Guy Gammon, MBBS, at 858-334-2165 or This email address is being protected from spambots. You need JavaScript enabled to view it., or Marianne Man­cini, MBA, at 858-334-2170 or mmancini@­ambitbio.com. The NLM Identifier is NCT02039726.

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