Leukemia Research Trials.

Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL)

Description – This is a phase I/II trial which 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 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. The trials main motive is to see if giving more than one drug with bortezomib and vorinostat may be a better treatment for acute lymphoblastic leukemia.

Lead Organization– St. Jude Children’s Research Hospital

Principal Investigator – Tanja A. Gruber

Location

  • California, Los Angeles, Children’s Hospital Los Angeles, Contact: Paul S. Gaynon, Phone: 323-361-2163 Email: pgaynon@chla.usc.edu
  • Orange, Children’s Hospital of Orange County, Contact: Ivan I. Kirov, Phone: 714-997-3000 Email: ikirov@choc.org
  • Palo Alto, Lucile Packard Children’s Hospital Stanford University, Contact: Norman James Lacayo, Phone: 650-497-8953 Email: lacayon@stanford.edu
  • San Diego, Rady Children’s Hospital-San Diego, Contact: Deborah E. Schiff, Phone: 858-966-5934 Email: dschiff@chsd.org
  • Minnesota, Minneapolis, Children’s Hospitals and Clinics of Minnesota – Minneapolis, Contact: Michael Kerr Richards, Phone: 612-813-5193 Email: michael.richards@childrensmn.org
  • North Carolina, Charlotte, Saint Jude Affiliate-Charlotte, Contact: Christine Marie Bolen, Phone: 704-384-1900 Email: cybolen@novanthealth.org
  • Ohio, Cincinnati, Cincinnati Children’s Hospital Medical Center, Contact: Erin Haag Breese, Phone: 513-636-2799 Email: erin.breese@cchmc.org
  • Cleveland, Rainbow Babies and Children’s Hospital, Contact: Yousif (Joe) H. Matloub, Phone: 216-844-5437 Email: yousif.matloub@uhhospitals.org
  • Oregon, Portland, Oregon Health and Science University, Contact: Bill Hoon Chang, Phone: 503-494-1080 Email: trials@ohsu.edu
  • Tennessee, Memphis, St. Jude Children’s Research Hospital, Contact: Tanja A. Gruber, Phone: 901-319-0070 Email: Tanja.Gruber@stjude.org
  • Virginia, Norfolk, Children’s Hospital of The King’s Daughters, Contact: Eric Jeffrey Lowe, Phone: 757-668-7243 Email: eric.lowe@chkd.org

 

Selinexor in Treating Younger Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

Description – This phase I trial studies the side effects and the best dose of selinexor in treating younger patients with acute lymphoblastic leukemia or acute myeloid leukemia that has returned or has become resistant to standard therapies. Selinexor may prevent leukemia cells from growing and may lead to the destruction of leukemia cells.

Lead Organization – Dana-Farber Harvard Cancer Center

Principal Investigator – Andrew Elliott Place

Locations

  • California, San Francisco, UCSF Medical Center-Parnassus, Contact: Elliot Stieglitz Email: elliot.stieglitz@ucsf.edu
  • Colorado, Aurora, Children’s Hospital Colorado, Contact: Lia Gore, Phone: 720-777-6672 Email: Lia.gore@ucdenver.edu
  • Georgia, Atlanta, Children’s Healthcare of Atlanta – Egleston, Contact: Melinda Gordon Pauly Email: melinda.pauly@choa.org
  • Massachusetts, Boston, Boston Children’s Hospital, Contact: Andrew Elliott Place, Phone: 617-632-2313 Email: andrew_place@dfci.harvard.edu
  • Dana-Farber Cancer Institute, Contact: Andrew Elliott Place, Phone: 617-632-2313 Email: andrew_place@dfci.harvard.edu
  • New York, New York, Columbia University / Herbert Irving Cancer Center, Contact: Maria Luisa Sulis Email: mls95@cumc.columbia.edu
  • Pennsylvania, Philadelphia, Children’s Hospital of Philadelphia, Contact: Richard Aplenc Email: raplenc@mail.med.upenn.edu
  • Texas, Houston, Texas Children’s Hospital, Contact: Rachel E. Rau Email: rerau@bcm.edu
  • Washington, Seattle, Seattle Children’s Hospital, Contact: Todd Michael Cooper, Phone: 404-785-1838 Email: Todd.cooper@seattlechildrens.org
  • Wisconsin, Milwaukee, Children’s Hospital of Wisconsin, Contact: Michael James Burke, Phone: 414-955-4198 Email: mmburke@mcw.edu

 

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

 

Description – 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.

Lead Organization – Dana-Farber Harvard Cancer Center

Principal Investigator – Lewis Barry Silverman

Locations

  • Massachusetts, Boston, Boston Children’s Hospital, Contact: Lewis Barry Silverman, Phone: 617-632-6191 Email: Lewis_Silverman@dfci.harvard.edu
  • Dana-Farber Cancer Institute, Contact: Lewis Barry Silverman, Phone: 617-632-6191 Email: Lewis_Silverman@dfci.harvard.edu
  • New York, Bronx, Montefiore Medical Center-Weiler Hospital, Contact: Lisa Gennarini, Phone: 718-741-2342 Email: Lfigueir@montefiore.org
  • Buffalo, Roswell Park Cancer Institute, Contact: Kara M. Kelly, Phone: 716-845-2333 Email: Kara.Kelly@RoswellPark.org
  • New York, Columbia University / Herbert Irving Cancer Center, Contact: Maria Luisa Sulis, Phone: 212-305-5808 Email: Mls95@cumc.columbia.edu
  • Rhode Island, Providence, Rhode Island Hospital, Contact: Jennifer J. Greene Welch, Phone: 401-444-5171 Email: jwelch@lifespan.org

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

Description – This 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 or has come back after treatment. 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.

Lead Organization – St. Jude Children’s Research Hospital

Principal Investigator – Jeffrey E. Rubnitz

Locations

  • Arizona, Phoenix, Phoenix Children’s Hospital, Contact: Jessica Boklan, Phone: 602-667-5669 Email: jboklan@phoenixchildrens.com
  • California, Palo Alto, Lucile Packard Children’s Hospital Stanford University, Contact: Norman James Lacayo, Phone: 650-497-8953 Email: lacayon@stanford.edu
  • Illinois, Chicago, University of Chicago Comprehensive Cancer Center, Contact: Jennifer Lynn McNeer, Phone: 773-702-6808 Email: jmcneer@peds.bsd.uchicago.edu
  • Tennessee, Memphis, St. Jude Children’s Research Hospital, Contact: Jeffrey E. Rubnitz, Phone: 901-216-1878 Email: jeffrey.rubnitz@stjude.org,
  • Texas, Fort Worth, Cook Children’s Medical Center, Contact: Kenneth Matthew Heym, Phone: 682-885-4007 Email: kenneth.heym@cookchildrens.org

 

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

Description – 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.

Lead Organization – Gamida Cell

Locations

  • Kansas, Kansas City, University of Kansas Cancer Center
  • Westwood, University of Kansas Hospital-Westwood Cancer Center
  • Minnesota, Minneapolis, University of Minnesota / Masonic Cancer Center
  • North Carolina, Durham, Duke University Medical Center, Contact: Mitchell Eric Horwitz, Phone: 919-668-1045 Email: mitchell.horwitz@duke.edu
  • Ohio, Cleveland, Case Comprehensive Cancer Center

 

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

Description – This phase II trial studies how well sirolimus, cyclosporine and mycophenolate mofetil works in preventing graft-vs-host disease in patients with blood cancer 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. Giving total-body irradiation together with sirolimus, cyclosporine, and mycophenolate mofetil before and after transplant may stop this from happening.

Lead Organization – Fred Hutch / University of Washington Cancer Consortium

Principal Investigator – Brenda M. Sandmaier

Locations

  • Colorado, Denver, Presbyterian – Saint Luke’s Medical Center – Health One, Contact: Michael Brian Maris, Phone: 720-754-4800 Email: Michael.Maris@healthonecares.com
  • Washington,
  1. i) Seattle, Fred Hutch / University of Washington Cancer Consortium, Contact: Brenda M. Sandmaier, Phone: 206-667-4961 Email: bsandmai@fredhutch.org
  2. ii) VA Puget Sound Health Care System, Contact: Thomas Reeve Chauncey, Phone: 206-762-1010 Email: chauncey@va.gov

 

Oxidative Phosphorylation Inhibitor IACS-010759 in Treating Patients with Relapsed or Refractory Acute Myeloid Leukemia

Description – This phase I trial studies the side effects and best dose of oxidative phosphorylation inhibitor IACS-010759 in treating patients with acute myeloid leukemia that has come back or does not respond to treatment. Oxidative phosphorylation inhibitor IACS-010759 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Lead Organization – M D Anderson Cancer Center

Principal Investigator – Marina Konopleva

Location– Texas, Houston, M D Anderson Cancer Center, Contact: Marina Konopleva, Phone: 713-794-1628

 

Donor-Derived Tumor-Associated Antigen-Specific T Cells in Treating Participants with Relapsed or Refractory acute myeloid leukemia or myelodysplastic syndrome

Description – This phase I trial studies the best dose and how well donor-derived multi-tumor-associated antigen-specific T cells work in treating participants with acute myeloid leukemia or myelodysplastic syndrome that have come back or does not respond. Tumor-associated antigen-specific T cells are immune system cells that may target cell proteins specific to tumor cells.

Lead Organization – Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center

Principal Investigator – Premal Lulla

Locations

  • Texas, Houston, Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center, Contact: Premal Lulla, Phone: 713-441-1450
  • Texas Children’s Hospital, Contact: Premal Lulla, Phone: 713-441-1450

 

 

Tretinoin and Arsenic Trioxide in Treating Patients with Untreated Acute Promyelocytic Leukemia

Description – This phase III trial studies tretinoin and arsenic trioxide in treating patients with newly diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic leukemia involves high doses of a common class of chemotherapy drugs called anthracyclines, which are known to cause long-term side effects, especially to the heart. Tretinoin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide may stop the growth of cancer cells by either killing the cells, by stopping them from dividing, or by stopping them from spreading. Completely removing or reducing the amount of anthracycline chemotherapy and giving tretinoin together with arsenic trioxide may be an effective treatment for acute promyelocytic leukemia and may reduce some of the long-term side effects.

Lead Organization – Children’s Oncology Group

Principal Investigator – Matthew A. Kutny

Locations

  • Phoenix, Phoenix Children’s Hospital, Contact: Jessica Boklan, Phone: 602-546-0920
  • California, Los Angeles, Cedars Sinai Medical Center, Contact: Fataneh (Fae) Majlessipour, Phone: 310-423-8965

-Children’s Hospital Los Angeles, Contact: Leo Mascarenhas Email: helpdesk@childrensoncologygroup.org

-Oakland, Children’s Hospital and Research Center at Oakland, Contact: Carla Barbara Golden Email: helpdesk@childrensoncologygroup.org

-Orange, Children’s Hospital of Orange County, Contact: Elyssa M. Rubin Email: helpdesk@childrensoncologygroup.org

– Palo Alto, Lucile Packard Children’s Hospital Stanford University, Contact: Sheri L Spunt Email: helpdesk@childrensoncologygroup.org

-San Diego, Rady Children’s Hospital – San Diego, Contact: William D. Roberts Email: helpdesk@childrensoncologygroup.org

  • Colorado, Denver, Rocky Mountain Hospital for Children-Presbyterian Saint Luke’s Medical Center, Contact: Jennifer Jocelyn Clark Email: helpdesk@childrensoncologygroup.org
  • Florida, Jacksonville, Nemours Children’s Clinic-Jacksonville, Contact: Emi H. Caywood Email: helpdesk@childrensoncologygroup.org,

-Miami, Nicklaus Children’s Hospital, Contact: Enrique Alberto Escalon Email: helpdesk@childrensoncologygroup.org

-Tampa, Saint Joseph’s Hospital / Children’s Hospital-Tampa, Contact: Mark J. Mogul, Phone: 704-384-5369

  • Georgia, Atlanta, Children’s Healthcare of Atlanta – Egleston, Contact: Himalee Shreekant Sabnis Email: helpdesk@childrensoncologygroup.org
  • Illinois, Chicago, Lurie Children’s Hospital-Chicago, Contact: Joanna Lynn Weinstein Email: helpdesk@childrensoncologygroup.org
  • Maryland, Baltimore, Johns Hopkins University / Sidney Kimmel Cancer Center, Contact: Cara Anne Rabik, Phone: 410-955-8804 Email: jhcccro@jhmi.edu
  • Massachusetts, Boston, Dana-Farber Cancer Institute, Contact: Barbara Alsen Degar, Phone: 877-442-3324,
  • Michigan, Ann Arbor, C S Mott Children’s Hospital, Contact: Rajen Mody Email: helpdesk@childrensoncologygroup.org
  • Rochester, Mayo Clinic, Contact: Carola A. S. Arndt, Phone: 855-776-0015
  • New Jersey, Newark, Newark Beth Israel Medical Center, Contact: Peri Kamalakar, Phone: 973-926-7230
  • New York, New York, Columbia University / Herbert Irving Cancer Center, Contact: Alice Lee Phone: 212-305-8615
  • Memorial Sloan Kettering Cancer Center, Contact: Kavitha Ramaswamy Email: helpdesk@childrensoncologygroup.org
  • Ohio, Cincinnati, Cincinnati Children’s Hospital Medical Center, Contact: Maureen Megan, O’Brien Email: helpdesk@childrensoncologygroup.org
  • Oregon, Portland, Legacy Emanuel Children’s Hospital, Contact: Janice Faye Olson, Phone: 503-413-8199
  • Pennsylvania, Philadelphia, Children’s Hospital of Philadelphia,
  • Tennessee, Memphis, St. Jude Children’s Research Hospital, Contact: Jeffrey E. Rubnitz Email: helpdesk@childrensoncologygroup.org
  • Washington, Seattle, Seattle Children’s Hospital, Contact: Douglas S. Hawkins Email: helpdesk@childrensoncologygroup.org

 

 

A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkin’s Lymphoma

Description – This is a phase I study of temsirolimus combined with dexamethasone, cyclophosphamide and etoposide in patients with relapsed acute lymphoblastic leukemia, lymphoblastic lymphoma or peripheral T-cell lymphoma.

Lead Organization – Therapeutic Advances in Childhood Leukemia Consortium

Locations

  • California, San Francisco, UCSF Medical Center-Mount Zion
  • Georgia, Atlanta, Children’s Healthcare of Atlanta – Egleston
  • Maryland, Baltimore, Johns Hopkins University / Sidney Kimmel Cancer Center
  • Massachusetts, Boston, Dana-Farber Cancer Institute
  • New York, New York, Columbia University / Herbert Irving Cancer Center
  • Ohio, Cleveland, Case Comprehensive Cancer Center,
  • Oregon, Portland, OHSU Knight Cancer Institute
  • Texas, Dallas, UT Southwestern / Simmons Cancer Center-Dallas, Contact: Marcella West Aguilar, Phone: 214-648-1479 Email: marcella.aguilar@utsouthwestern.edu
  • Houston, Texas Children’s Hospital.

 

 

CD19 / CD22 Chimeric Antigen Receptor T Cells and Chemotherapy in Treating Children or Young Adults with Recurrent or Refractory CD19 Positive B Acute Lymphoblastic Leukemia

Description – This phase I trial studies the best dose and side effects of CD19 / CD22 chimeric antigen receptor (CAR) T cells when given together with chemotherapy, and to see how well they work in treating children or young adults with CD19 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. A CAR is a genetically-engineered receptor made so that immune cells can attack cancer cells by recognizing and responding to the CD19 / CD22 proteins. These proteins are commonly found in B acute lymphoblastic leukemia. Drugs used in chemotherapy, such as 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 CD19 / CD22-CAR T cells and chemotherapy may work better in treating children or young adults with B acute lymphoblastic leukemia.

Lead Organization – Stanford Cancer Institute Palo Alto

Principal Investigator – Crystal L. Mackall

Locations

  • California, Palo Alto, Lucile Packard Children’s Hospital Stanford University, Contact: Crystal L. Mackall, Phone: 650-725-2553 Email: cmackall@stanford.edu
  • Stanford Cancer Institute Palo Alto, Contact: Crystal L. Mackall, Phone: 650-725-2533 Email: cmackall@stanford.edu

 

 

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

Description – This phase I trial studies the side effects and best dose of autologous CD5-specific CAR-28 zeta CAR T-cells when given together with cyclophosphamide and fludarabine in treating participants with T-cell cancers expressing the CD5 antigen 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.

Lead Organization – Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center

Principal Investigator – Rayne Helen Rouce

Location

  • Texas, Houston, Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center, Contact: Rayne Helen Rouce, ,Phone: 832-824-4716
  • Texas Children’s Hospital, Contact: Rayne Helen Rouce, Phone: 832-824-4716

 

 

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

Description – 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.

Lead Organization – Seattle Children’s Hospital

Principal Investigator – Rebecca Alice Emmons Gardner

Locations –

  • California, Los Angeles, Children’s Hospital Los Angeles, Contact: Michael Allen Pulsipher, Phone: 323-361-2121 Email: mpulsipher@chla.usc.edu
  • Washington, Seattle, Seattle Children’s Hospital, Contact: Rebecca Alice Emmons Gardner, Phone: 206-987-2106 Email: rebecca.gardner@seattlechildrens.org

 

Thiotepa, Fludarabine Phosphate, and Melphalan Hydrochloride in Treating Participants with Blood Cancer Undergoing Donor Stem Cell Transplant

Description – This phase II trial studies how well thiotepa, fludarabine phosphate, and melphalan hydrochloride work in treating participants with blood cancer who are undergoing a donor stem cell transplant. Drugs used in chemotherapy, such as thiotepa, fludarabine phosphate, and melphalan 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.

Lead Organization – Case Comprehensive Cancer Center

Principal Investigator – Leland L. Metheny

Locations

  • Cleveland, Case Comprehensive Cancer Center, Contact: Leland L. Metheny, Phone: 216-844-0139 Email: Leland.Metheny@uhhospitals.org

 

Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients with Blood Cancer

Description – This phase II trial studies how well fludarabine phosphate, cyclophosphamide, total body irradiation, and donor stem cell transplant work in treating patients with blood cancer. Drugs used in chemotherapy, such as 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. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells and 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. The donated stem cells may also replace the patient’s immune cells and help destroy any remaining cancer cells.

Lead Organization – Roswell Park Cancer Institute

Principal Investigator – Sophia Rebecca Balderman

Locations

New York, Buffalo, Roswell Park Cancer Institute, Contact: Sophia Rebecca Balderman, Phone: 716-845-6972 Email: Sophia.Balderman@roswellpark.org

 

 

Autologous IC9-CAR19 T cells in Treating Patients with Recurrent Acute Lymphoblastic Leukemia

Descriptions – This phase I trial studies the side effect of autologous inducible caspase 9 chimeric antigen receptor targeting CD19 antigen (iC9-CAR19) T cells in treating patients with acute lymphoblastic leukemia that has come back. IC9-CAR19 T cells combine antibodies and T cells. Antibodies are proteins that protect the body from disease caused by bacteria or toxic substances and by stopping them from growing. T cells are special infection-fighting blood cells that can kill other cells, including cancer cells or cells that are infected.

Lead Organization – UNC Lineberger Comprehensive Cancer Center

Principal Investigator – Matthew C. Foster

Locations

  • North Carolina, Chapel Hill, UNC Lineberger Comprehensive Cancer Center, Contact: Matthew C. Foster, Phone: 919-843-2447 Email: matthew_foster@med.unc.edu

 

Standard of Care + / – Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML

Description – To determine if the addition of midostaurin to Standard of Care therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogeneic hematopoietic stem cell transplant.

Lead Organization – Novartis Pharmaceuticals Corporation

Location

  • California, Los Angeles, UCLA / Jonsson Comprehensive Cancer Center, Contact: Gary John Schiller, Phone: 310-825-5513
  • Illinois, Chicago, University of Chicago Comprehensive Cancer Center, Contact: Wendy Stock, Phone: 773-834-2487
  • New York, New York, Memorial Sloan Kettering Cancer Center, Contact: Esperanza Bouza, Papadopoulos, Phone: 212-639-3859
  • Washington, Seattle, Fred Hutch / University of Washington Cancer Consortium, Contact: Bart Lee Scott, Phone: 800-422-6237

 

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

DescriptionThe 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.

Lead Organization – Bristol-Myers Squibb

Location:

  • California, Los Angeles, Children’s Hospital Los Angeles, Contact: David Robert Freyer, Phone: 323-361-5973
  • San Diego, Rady Children’s Hospital – San Diego,
  • Georgia, Atlanta, Children’s Healthcare of Atlanta – Egleston, Contact: Mike Aquino Briones, Phone: 404-785-4746
  • Iowa, Iowa City, University of Iowa / Holden Comprehensive Cancer Center,
  • Maryland, Baltimore, Johns Hopkins University / Sidney Kimmel Cancer Center, Contact: Patrick A. Brown, Phone: 410-955-0432
  • Minnesota, Minneapolis, University of Minnesota / Masonic Cancer Center
  • Rochester, Mayo Clinic.
  • New Jersey, New Brunswick, Rutgers Cancer Institute of New Jersey
  • New York, Buffalo, Roswell Park Cancer Institute, Contact: Barbara J. Bambach, Phone: 716-845-4561
  • North Carolina, Chapel Hill, UNC Lineberger Comprehensive Cancer Center
  • Ohio, Cleveland, Case Comprehensive Cancer Center
  • Pennsylvania, Pittsburgh, Children’s Hospital of Pittsburgh of UPMC
  • Tennessee, Nashville, Vanderbilt University / Ingram Cancer Center
  • Texas, Houston, Texas Children’s Hospital
  • San Antonio, University Hospital, Contact: Anne-Marie R. Langevin, Phone: 210-562-9025

 

 Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients with Hematologic Disease

Description – This phase II trial studies how well giving an umbilical cord blood transplant together with cyclophosphamide, fludarabine phosphate, and total-body irradiation works in treating patients with hematologic disease. Giving chemotherapy, such as cyclophosphamide and fludarabine phosphate, and TBI before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps 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 cyclosporine and mycophenolate mofetil after transplant may stop this from happening.

Lead Organization -Fred Hutch / University of Washington Cancer Consortium

Principal Investigator – Ann E Dahlberg

Location

Washington, Seattle, Fred Hutch / University of Washington Cancer Consortium, Contact: Ann E Dahlberg, Phone: 206-667-1959 Email: adahlber@fredhutch.org

VA Puget Sound Health Care System, Contact: Thomas Reeve Chauncey, Phone: 206-764-2199 Email: tchaunce@u.washington.edu

 

 

 Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML

Description – A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib in addition to standard first-line treatment of AML or midostaurin and standard treatment. Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3 mutation status is confirmed and additional eligibility is established, a subject will be randomized and enter into the treatment phase.

Lead Organization – Arog Pharmaceuticals, Inc.

Location-

  • Illinois,Chicago, University of Chicago Comprehensive Cancer Center
  • Michigan,Detroit, Wayne State University / Karmanos Cancer Institute
  • New York, New York, Icahn School of Medicine at Mount Sinai