Treatment Clinical Trials for Childhood Acute Lymphoblastic Leukemia

Clinical trials are research studies that involve people. The clinical trials on this list are for childhood acute lymphoblastic leukemia treatment. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-25 of 40
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  • Bortezomib, Vorinostat, and Combination Chemotherapy in Treating Infants with Newly Diagnosed Acute Lymphoblastic Leukemia

    This phase I / II trial studies the side effects and best dose of vorinostat and to see how well it works when given together with bortezomib and combination chemotherapy in treating infants (patients less than 1 year old) with newly diagnosed acute lymphoblastic leukemia. Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as methotrexate, hydrocortisone, and cytarabine, 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) with bortezomib and vorinostat may be a better treatment for acute lymphoblastic leukemia.
    Location: 11 locations

  • A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma

    This is a phase I study of temsirolimus (Torisel) combined with dexamethasone, cyclophosphamide and etoposide in patients with relapsed acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL) or peripheral T-cell lymphoma (PTL).
    Location: 10 locations

  • Risk Classification Schemes in Identifying Better Treatment Options for Children and Adolescents with Acute Lymphoblastic Leukemia

    This randomized phase III trial studies risk classification schemes in identifying better treatment options for children and adolescents with acute lymphoblastic leukemia. Risk factor classification may help identify how strong treatment should be for patients with acute lymphoblastic leukemia.
    Location: 6 locations

  • Transplantation of Ex Vivo Expanded, UCB-derived, Stem & Progenitor Cells vs. Unmanipulated UCB for HM Patients

    This study is an open-label, controlled, multicenter, international, Phase III, randomized study of transplantation of NiCord® versus transplantation of one or two unmanipulated, unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia or lymphoma, all with required disease features rendering them eligible for allogeneic transplantation.
    Location: 11 locations

  • Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy for Children, Adolescents, and Young Adults With Relapsed ALL

    This is a pilot study utilizing Marqibo® (vincristine sulfate liposome injection) combined with dexamethasone, mitoxantrone and asparaginase (UK ALL R3) for relapsed acute lymphoblastic leukemia (ALL).
    Location: 10 locations

  • Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

    The purpose of the study is to determine the maximum tolerated dose and assess the safety, tolerability and activity of carfilzomib, alone and in combination with induction chemotherapy, in children with relapsed or refractory acute lymphoblastic leukemia (ALL).
    Location: 9 locations

  • A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies

    An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or refractory malignancies.
    Location: 7 locations

  • Selinexor, Fludarabine Phosphate, and Cytarabine in Treating Younger Patients with Refractory or Relapsed Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndromes

    This pilot phase I / II trial studies the side effects and best dose of selinexor when given together with fludarabine phosphate and cytarabine in treating younger patients with acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes that did not go into remission after treatment (refractory) or has come back after treatment (relapsed). One way cancer cells continue to grow by escaping from mechanisms that normally control human cell growth, such as a type of protein called a tumor suppressor protein. Tumor suppressor proteins normally cause cancer cells to die. Selinexor works by trapping tumor suppressor proteins within the cancer cells, causing them to stop growing or die. Fludarabine phosphate and cytarabine are drugs used in chemotherapy that stop cancer cells from dividing. Giving selinexor with fludarabine phosphate and cytarabine may work better in treating acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes in younger patients.
    Location: 6 locations

  • Sirolimus, Cyclosporine, and Mycophenolate Mofetil in Preventing Graft-versus-Host Disease in Treating Patients with Blood Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant

    This phase II trial studies how well sirolimus, cyclosporine and mycophenolate mofetil works in preventing graft-vs-host disease (GVHD) in patients with blood cancer undergoing donor peripheral blood stem cell (PBSC) transplant. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation together with sirolimus, cyclosporine, and mycophenolate mofetil before and after transplant may stop this from happening.
    Location: 3 locations

  • T-allo10 Cell Infusion before Donor Stem Cell Transplant in Treating Patients with Relapsed or Refractory Blood Cancer

    This phase I trial studies side effects and best dose of T-allo10 cells and to see how well they work when given before donor stem cell transplant in treating patients with blood cancer that has come back or does not respond to treatment. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft versus host disease). Giving T-allo10 cells before the transplant may help prevent this from happening. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient’s immune cells and help destroy any remaining cancer cells. Giving T-allo10 cells before donor stem cell transplant may work better in treating patients with blood cancer that has come back or dose not respond to treatment.
    Location: 2 locations

  • CD5.CAR / 28 T Cells, Cyclophosphamide, and Fludarabine in Treating Participants with Recurrent T-Cell Malignancies Expressing the CD5 Antigen

    This phase I trial studies the side effects and best dose of autologous CD5-specific CAR-28 zeta CAR T-cells (CD5.CAR / 28 T cells) when given together with cyclophosphamide and fludarabine in treating participants with T-cell cancers expressing the CD5 antigen that that has come back. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. The antibody used in this study is called anti-CD5, which sticks to T-cell leukemia or lymphoma cells because of a substance on the outside of these cells called CD5. The T cells will also contain a substance called CD28 which may help stimulate the T cells and may make them last longer. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, 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 CD5.CAR / 28 T cells with cyclophosphamide and fludarabine may work better in treating participants with T-cell malignancies expressing the CD5 antigen.
    Location: 2 locations

  • Study of DCC-3014 in Patients With Advanced Malignancies

    This is a multicenter, open-label Phase 1 study of DCC-3014 in patients with advanced malignancies, featuring solid tumors, but will also enroll select patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), acute lymphocytic leukemia (ALL), or chronic lymphocytic leukemia (CLL). There will be an Escalation Phase and an Expansion Phase in this study
    Location: 2 locations

  • Selective Depletion of CD45RA+ T Cells from Allogeneic Peripheral Blood Stem Cell Grafts from HLA-Matched Related and Unrelated Donors in Preventing GVHD

    This phase II trial studies how well selective T cell depletion works in preventing graft-versus-host disease (GVHD) in patients with acute lymphocytic leukemia, acute myeloid leukemia, or chronic myelogenous leukemia undergoing donor peripheral blood stem cell transplant. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing a subset of the T cells from the donor cells before transplant may stop this from happening.
    Location: 2 locations

  • CD19-CAR T-cell Immunotherapy in Treating Patients with CD19-Positive Leukemia

    This phase I / II clinical trial studies the side effects of CD19-CAR T-cell immunotherapy and how well it works in treating patients with CD19-positive leukemia. Biological therapies, such as CD19-CAR T-cell immunotherapy, use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them.
    Location: 2 locations

  • Risk-Directed Therapy in Treating Young Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

    This phase II trial studies how well risk directed therapy works in treating younger patients with acute lymphoblastic leukemia that has returned or does not responded to treatment. Giving chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
    Location: 2 locations

  • HA-1 T TCR T cell Immunotherapy for the Treating of Patients with Relapsed or Refractory Acute Leukemia after Donor Stem Cell Transplant

    This phase I trial studies the side effects and best dose of CD4+ and CD8+ HA-1 T cell receptor (TCR) T cells in treating patients with acute leukemia that has come back or does not respond to treatment following donor stem cell transplant. T cell receptor is a special protein on T cells that helps them recognize proteins on other cells including leukemia. HA-1 is a protein that is present on the surface of some peoples' blood cells, including leukemia. HA-1 T cell immunotherapy enables genes to be added to the donor cells to make them recognize HA-1 markers on leukemia cells.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • Combination Chemotherapy in Treating Patients with Acute Lymphoblastic Leukemia or Lymphoma

    This randomized phase II / III trial studies the side effects of combination chemotherapy and how well it works in treating patients with acute lymphoblastic leukemia or lymphoma. Drugs used in combination 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.
    Location: St. Jude Children's Research Hospital, Memphis, Tennessee

  • Low-Dose Daunorubicin Hydrochloride in Treating Patients with Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

    This pilot clinical trial studies how well low-dose daunorubicin hydrochloride works in treating patients with acute myeloid leukemia or acute lymphoblastic leukemia that has come back or has not responded to treatment. Drugs used in chemotherapy, such as daunorubicin hydrochloride, 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.
    Location: University of Kansas Cancer Center, Kansas City, Kansas

  • Partially HLA-Mismatched Related Donor Stem Cell Transplant Using Killer Immunoglobulin Receptor and Human Leukocyte Antigen Based Donor Selection in Treating Patients with Hematologic Malignancies

    This pilot clinical trial studies how well partially human leukocyte antigen (HLA)-mismatched related donor stem cell transplant using killer immunoglobulin receptor or HLA based donor selection works in treating patients with hematologic malignancies. Partially mismatched donor stem cells may reduce the risk of cancer recurring after transplant.
    Location: Memorial Sloan Kettering Cancer Center, New York, New York

  • Blinatumomab and Combination Chemotherapy as Frontline Therapy in Treating Patients with B Acute Lymphoblastic Leukemia

    This phase II trial studies how well blinatumomab and combination chemotherapy work as frontline therapy in treating patients with B acute lymphoblastic leukemia. Monoclonal antibodies, such as blinatumomab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, cytarabine, mercaptopurine, methotrexate, and prednisone 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 blinatumomab and combination chemotherapy may work better in treating patients with B acute lymphoblastic leukemia.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients with Blood Cancer Undergoing Donor Stem Cell Transplant

    This phase II trial studies the side effect of busulfan, fludarabine phosphate, and post-transplant cyclophosphamide in treating patients with blood cancer undergoing donor stem cell transplant. Drugs used in chemotherapy, such as busulfan, fludarabine phosphate and cyclophosphamide 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 chemotherapy such as busulfan and fludarabine phosphate before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclophosphamide after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them.
    Location: M D Anderson Cancer Center, Houston, Texas

  • Blinatumomab and T Cell Depleted Donor Blood Cell Transplant in Treating Younger Patients with Relapsed or Refractory Hematologic Malignancy after a Previous Transplant

    This phase II trial studies how well blinatumomab and T cell depleted donor blood cell transplant work in treating children and young adults with hematologic cancer that has not responded or has come back after a previous transplant. White blood cells from donors may be able to kill cancer cells in patients with hematologic cancer. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Removing the T cells from the donor cells before the transplant may stop this from happening. Monoclonal antibodies, such as blinatumomab, may interfere with the ability of cancer cells to grow and spread. Giving blinatumomab after a blood cell transplant may destroy any remaining cancer cells.
    Location: St. Jude Children's Research Hospital, Memphis, Tennessee

  • Personalized NK Cell Therapy after Chemotherapy and Cord Blood Transplant in Treating Patients with Myelodysplastic Syndrome, Leukemia, Lymphoma or Multiple Myeloma

    This phase II clinical trial studies how well personalized natural killer (NK) cell therapy works after chemotherapy and umbilical cord blood transplant in treating patients with myelodysplastic syndrome, leukemia, lymphoma or multiple myeloma. This clinical trial will test cord blood (CB) selection for human leukocyte antigen (HLA)-C1 / x recipients based on HLA-killer-cell immunoglobulin-like receptor (KIR) typing, and adoptive therapy with CB-derived NK cells for HLA-C2 / C2 patients. Natural killer cells may kill tumor cells that remain in the body after chemotherapy treatment and lessen the risk of graft versus host disease after cord blood transplant.
    Location: M D Anderson Cancer Center, Houston, Texas

  • High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients with Relapsed or Refractory Acute Leukemia

    This pilot clinical trial studies the feasibility of choosing treatment based on a high throughput ex vivo drug sensitivity assay in combination with mutation analysis for patients with acute leukemia that has returned after a period of improvement or does not respond to treatment. A high throughput screening assay tests many different drugs individually or in combination that kill leukemia cells in tiny chambers at the same time. High throughput drug sensitivity assay and mutation analysis may help guide the choice most effective for an individual’s acute leukemia.
    Location: Fred Hutch / University of Washington Cancer Consortium, Seattle, Washington

  • CD19-Specific T-cells in Treating Patients with Advanced Lymphoid Malignancies

    This phase I clinical trial studies the side effects and best dose of CD19-specific T-cells in treating patients with lymphoid malignancies that have spread to other places in the body and usually cannot be cured or controlled with treatment. Sometimes researchers change the deoxyribonucleic acid (DNA) (genetic material in cells) of donated T-cells (white blood cells that support the immune system) using a process called "gene transfer." Gene transfer involves drawing blood from the patient, and then separating out the T-cells using a machine. Researchers then perform a gene transfer to change the T-cells' DNA, and then inject the changed T-cells into the body of the patient. Injecting modified T-cells made from the patient may help attack cancer cells in patients with advanced B-cell lymphoma or leukemia.
    Location: M D Anderson Cancer Center, Houston, Texas


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