acute lymphocytic leukemia

Displaying 24 studies

  • CD19 CAR T-Cell Therapy Long Term Follow Up Study Scottsdale/Phoenix, AZ

    Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CD19 directed CAR T-cells (CD19 CART) for 15 years following last CD19 CART (e.g. CTL019) infusion to assess the risk of delayed adverse events, monitor for replication competent lentivirus  and assess long-term efficacy, including vector persistence.

  • Phase 2 Trial of Blinatumomab in Philadelphia Positive/BCR-ABL Positive Acute Lymphoblastic Leukemia Rochester, MN

    This study seeks adult subjects with R/R Ph+ B-precursor ALL. This is a single-arm Simon II stage design, multicenter study consisting of a screening period, an induction treatment period (2 cycles of blinatumomab), a consolidation treatment period (up to 3 additional cycles of blinatumomab for applicable subjects), and a safety follow-up visit 30 days after treatment. Following the safety follow-up visit, subjects will be followed for response duration and survival every 3 months for 18 months or death, whichever occurs first.

  • Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations Rochester, MN

    This randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.

  • Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia Rochester, MN

    This phase III trial is studying the side effects and how well giving dasatinib together with combination chemotherapy works in treating young patients with newly diagnosed acute lymphoblastic leukemia (ALL). Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving dasatinib together with combination chemotherapy may kill more cancer cells.

  • A Study Evaluating KTE-X19 in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-3) Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and efficacy of KTE-X19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).

  • Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia Rochester, MN

    This randomized phase III trial studies 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, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as blinatumomab, may block cancer growth in different ways by targeting certain cells. It is not yet known whether combination chemotherapy is more effective ...

  • Sapanisertib in Treating Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    This phase II trial studies how well sapanisertib works in treating patients with acute lymphoblastic leukemia that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory). Sapanisertib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

  • Ph 3 Trial of Blinatumomab vs Investigator's Choice of Chemotherapy in Patients with Relapsed or Refractory ALL Rochester, MN

    This study seeks adult subjects with Relapsed/Refractory (R/R) B-precursor ALL. This is a phase 3 randomized, open label study designed to evaluate the efficacy of blinatumomab versus investigator choice of SOC chemotherapy. Adult subjects with R/R B-precursor ALL will be randomized in a 2:1 ratio to receive blinatumomab or treatment with investigator choice of 1 of 4 protocol defined SOC chemotherapy regimens. Primary Endpoint is Overall Survival.

  • Study of Efficacy and Safety of CTL019 in Adult ALL Patients Scottsdale/Phoenix, AZ

    The purpose of this study is to determine the effectiveness and safety of CTL019 in adult patients with r/r B-cell ALL. The study will have the following sequential phases: Screening, Pre-Treatment, Treatment and Primary Follow-up, Secondary Follow-up (Relapse Follow-up) and Survival Follow-up. The total duration of the primary follow-up is 1 year from cell infusion. Safety will be assessed until the end of the treatment and primary follow-up phase.

  • A Multi-Center Study Evaluating KTE-X19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia Rochester, MN

    This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and efficacy of KTE-X19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL) in pediatric or adolescent subjects.

  • Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies Jacksonville, FL

    This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.

  • Metagenomic Shotgun Sequencing of Blood to Identify Pathogens in Patients with Neutropenic Fever Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is to determine whether metagenomic shotgun sequencing can identify microorganisms present in blood sample of patients with febrile neutropenia. 

  • A Safety Study of SGN-CD19A for Leukemia and Lymphoma Scottsdale/Phoenix, AZ; Jacksonville, FL

    This is a phase 1, open-label, dose-escalation, multicenter study to evaluate the safety and tolerability of SGN-CD19A in adult and pediatric patients with relapsed or refractory B-lineage acute lymphoblastic leukemia (B-ALL), Burkitt lymphoma or leukemia, or B-lineage lymphoblastic lymphoma (B-LBL).

  • A Study to Determine the Effects of Activity by Ambulation in Hospital Premises versus Strict Protective Isolation on Quality of Life in Severely Neutropenic Cancer Patients during Hospitalization Jacksonville, FL

    The purpose of this study is to determine if allowing patients to ambulate in the hallways outside of their hospital room by relaxing the policy of strict protective isolation in neutropenic patients improves the quality of life, and if this increases the risk of infection among these patients during hospitalization.

  • Nilotinib and Combination Chemotherapy in Treating Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Blastic Phase Chronic Myelogenous Leukemia Scottsdale/Phoenix, AZ; Rochester, MN

    In this study researchers want to find out more about the side effects of a new drug for Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) and chronic myelogenous leukemia (CML) blastic phase (BP) and if this disease will respond better to nilotinib combined with standard hyper-CVAD therapy rather than hyper-CVAD alone. Hyper-CVAD is a combination of cyclophosphamide, mesna, vincristine (vincristine sulfate), doxorubicin (doxorubicin hydrochloride), dexamethasone, methotrexate, cytarabine, and rituximab (only for patients with cluster of differentiation [CD]20 positive disease). Researchers don't know all the ways that this drug may affect people

  • A Study of Using Bortezomib and Combination Chemotherapy in Treating Children with Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma Rochester, MN

    This pilot, phase II trial studies the side effects of giving bortezomib together with combination chemotherapy and to see how well it works in treating young patients with relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells.

  • A Study to Provide Access to CTL019 Out of Specification Managed Access Program (MAP) for ALL or DLBCL Patients Jacksonville, FL; Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is to provide access to CTL019 through Managed Access Program (MAP) for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.

  • A Study to Evaluate Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation Rochester, MN

    The primary purpose of this study is to estimate and compare overall survival between the two arms:  patients who are Very Likely to find a Matched Unrelated Donor (MUD) versus those who are Very Unlikely to find a MUD.

  • Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies Scottsdale/Phoenix, AZ; Rochester, MN

    Primary Objective: Phase 1: To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984 (Isatuximab). Phase 2 (stage 1): To evaluate the activity of single-agent Isatuximab at different doses/schedules and to select dose and regimen to further evaluate the overall response rate (ORR) of Isatuximab as single agent or in combination with dexamethasone. Phase 2 (stage 2): To evaluate the activity in terms of overall response rate (ORR) of Isatuximab at the selected dose/schedule from stage1, as single agent (ISA arm) and in combination with dexamethasone (ISAdex arm). Secondary Objectives: Phase 1: - To characterize the global safety ...

  • A Study of the Safety and Effectiveness of Apixaban in Preventing Blood Clots in Children With Leukemia Who Have a Central Venous Catheter and Are Treated With Asparaginase Rochester, MN

    The purpose of this study is to compare the effect of a blood thinning drug called Apixaban versus no administration of a blood thinning drug, in preventing blood clots in children with leukemia or lymphoma. Patients must be receiving chemotherapy, including asparaginase, and have a central line (a catheter inserted for administration of medications and blood sampling).

  • Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies Rochester, MN

    This clinical trial is studying long-term follow-up in patients who are or have participated in Children's Oncology Group studies. Developing a way to track patients enrolled in Children's Oncology Group studies will help doctors gather long-term follow-up information and may help the study of cancer in the future.

  • Allogeneic Transplant in HIV Patients (BMT CTN 0903) Scottsdale/Phoenix, AZ; Rochester, MN

    The rationale for this trial is to demonstrate the feasibility and safety of allogeneic HCT for patients with chemotherapy-sensitive hematological malignancies and coincident HIV-infection. In particular, the trial will focus on the 100-day non-relapse mortality as an indicator of the safety of transplant in this patient population. Correlative assays will focus upon the incidence of infectious complications in this patient population, the evolution of HIV infection and immunological reconstitution. Where feasible (and when this can be accomplished without compromise of either the donor quality or the timeliness of transplantation), an attempt will be made to identify donors who are homozygotes ...

  • The Circulating Cell-free Genome Atlas Study Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop assays to detect cancer early in blood. The purpose of this study is to collect biological samples from donors with a new diagnosis of cancer (blood and tumor tissue) and from donors who do not have a diagnosis of cancer (blood) in order to characterize the population heterogeneity in cancer and non-cancer subjects and to develop models for distinguishing cancer from non-cancer.

  • A Study to Evaluate Exercise for Cancer Patients at Risk of Falling Rochester, MN

    The purpose of this study is to develop a data-driven approach that enables healthcare providers to “prescribe” exercise in the appropriate dose in a manner analogous to prescribing a drug.

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