Phase I

Study Title: Phase Ib Study of Nivolumab and Dasatinib in Patients With Relapsed/Refractory Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

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

Study Sponsor and Collaborators: Northwestern University, National Cancer Institute

Purpose: To determine the acceptable upper limit dose of nivolumab in combination with dasatinib that may be given to patients with relapsed/refractory Ph+ ALL

Primary Outcome Measures: Incidence of dose-limiting toxicity [time frame: up to 28 days]

Principal Investigator: Shira ­Dinner, MD, Northwestern University; contact Study Coordinator at (312) 695-1301, cancertrials@northwestern.edu

ClinicalTrials.gov Identifier: NCT02819804

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Study Title: Phase I Study to Evaluate Cellular Immunotherapy Using Memory-Enriched T Cells Lentivirally Transduced to Express a CD19-Specific, Hinge-Optimized, CD28-Costimulatory Chimeric Receptor and a Truncated EGFR Following Lymphodepleting Chemotherapy in Adult Patients With High-Risk CD19+ ALL

Study Type: Phase I/interventional/
parallel assignment

Study Sponsor and Collaborators: City of Hope Medical Center, National Cancer Institute

Purpose: To study the side effects and best dose of cellular immunotherapy in treating patients with high-risk ALL. Placing a modified gene into white blood cells may help the body build an immune response to kill cancer cells.

Primary Outcome Measures: Toxicity profile of T-cell infusion as defined by all toxicities associated with T cells at the probably or definite levels assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (v4.0) [time frame: up to 15 years]; dose-limiting toxicity rate, complete response, or complete response with incomplete bone marrow recovery [time frame: up to 28 years]

Principal Investigator: Samer Khaled, MD, City of Hope Medical Center; (626) 256-4673; skhaled@coh.org

ClinicalTrials.gov Identifier: NCT02146924

Phase II

Study Title: Phase II Study of Subcutaneous Bortezomib in Combination With Chemotherapy in Relapsed/Refractory Adult ALL

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

Study Sponsor and Collaborators: Stanford University, National Cancer Institute

Purpose: To study how well giving bortezomib together with combination chemotherapy works in treating patients with relapsed or refractory ALL. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Primary Outcome Measures: Complete response rate [time frame: on day 29 at the end of induction therapy]

Principal Investigator: Michaela Liedtke, MD, Stanford University; contact Uzma Ahmed, (650) 723-0670; uzma.ahmed@stanford.edu

ClinicalTrials.gov Identifier: NCT01769209

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Study Title: Therapeutic Interventions for Peripheral Neuropathy/Neuropathic Pain Induced by Vincristine Treatment for Childhood ALL on Total XVI Protocol

Study Type: Phase II/interventional/parallel assignment

Study Sponsor and Collaborators: St. Jude Children’s Research Hospital

Purpose: To study if gabapentin treatment will reduce the severity of neuropathic pain/peripheral neuropathy in patients receiving vincristine during treatment for ALL on the Total XVI protocol (or for those being treated “as per TOTXVI protocol”), as measured by two outcome measures: the daily dose of morphine used as needed for pain in addition to either gabapentin or placebo, as randomized, and the pain scores assessed daily

Primary Outcome Measures: Daily total dose of oral morphine (mg/kg/d) [time frame: daily, beginning day 1 for a maximum of 21 days]

Principal Investigator: Doralina Anghelescu, MD, St. Jude Children’s Research Hospital; (866) 278-5833; referralinfo@stjude.org

ClinicalTrials.gov Identifier: NCT01506453

Phase III

Study Title: A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B-Lineage ALL in Adults

Study Type: Phase III/interventional/parallel assignment

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To study combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, nonreceptor tyrosine kinase (ABL)-negative B-lineage ALL

Primary Outcome Measures: Overall survival [time frame: time between randomization and death from any cause, assessed up to 10 years]

Principal Investigator: Mark ­Litzow, MD, ECOG-ACRIN Cancer Research Group; 386 study locations available, visit clinicaltrials.gov for more information.

ClinicalTrials.gov Identifier: NCT02003222

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Study Title: A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL

Study Type: Phase III/interventional/parallel assignment

Study Sponsor and Collaborators: Children’s Oncology Group, National Cancer Institute

Purpose: To study compliance to a mercaptopurine treatment intervention compared to standard of care in younger patients with ALL in remission. Assessing ways to help patients who have ALL to take their medications as prescribed may help them in taking their medications more consistently and may improve treatment outcomes.

Primary Outcome Measures: Proportion of patients with adherence rate greater than or equal to 95% to mercaptopurine as measured by Medication Event Monitoring Systems, red cell thioguanine nucleotide levels [time frame: 4 months]

Principal Investigator: Smita ­Bhatia, MD, MPH, Children’s Oncology Group; 83 study locations available, visit clinicaltrials.gov for more information.

ClinicalTrials.gov Identifier: NCT01503632 ■

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.