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Sponsored by: |
Children's Cancer and Leukaemia Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00334672 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of hemophagocytic lymphohistiocytosis cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more hemophagocytic lymphohistiocytosis cells. A donor stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Cyclosporine and methotrexate may stop this from happening.
PURPOSE: This phase III trial is studying how well combination chemotherapy followed by a donor stem cell transplant works in treating patients with hemophagocytic lymphohistiocytosis.
Condition | Intervention | Phase |
---|---|---|
Precancerous/Nonmalignant Condition |
Drug: anti-thymocyte globulin Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: dexamethasone Drug: etoposide Drug: methotrexate Drug: mycophenolate mofetil Drug: therapeutic hydrocortisone Procedure: allogeneic hematopoietic stem cell transplantation Procedure: biopsy Procedure: laboratory biomarker analysis |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Hemophagocytic Lymphohistiocytosis |
Estimated Enrollment: | 288 |
Study Start Date: | March 2006 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | up to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed hemophagocytic lymphohistiocytosis (HLH) meeting 1 of the following criteria*:
Diagnosis by meeting 5 out of 8 of the following criteria:
Clinical criteria:
Laboratory criteria:
Cytopenias affecting ≥ 2 of 3 lineages in the peripheral blood, including the following:
Hypertriglyceridemia and/or hypofibrinogenemia:
Histopathologic criteria:
Hemophagocytosis in bone marrow, spleen, or lymph nodes
New diagnostic criteria:
Acceptable donor meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Ireland | |
Our Lady's Hospital for Sick Children Crumlin | Recruiting |
Dublin, Ireland, 12 | |
Contact: Fin Breatnach, MD, FRCPE 353-1-409-6659 fin.breatnach@olhsc.ie | |
United Kingdom, England | |
Addenbrooke's Hospital | Recruiting |
Cambridge, England, United Kingdom, CB2 2QQ | |
Contact: Amos Burke, MD 44-1223-348-151 | |
Birmingham Children's Hospital | Recruiting |
Birmingham, England, United Kingdom, B4 6NH | |
Contact: Martin W. English, MD 44-121-333-8412 martin.english@bch.nhs.uk | |
Children's Hospital - Sheffield | Recruiting |
Sheffield, England, United Kingdom, S10 2TH | |
Contact: Mary P. Gerrard, BSc, MBChB, FRCP, FRCPCH 44-114-271-7366 mary.gerrard@sch.nhs.uk | |
Great Ormond Street Hospital for Children | Recruiting |
London, England, United Kingdom, WC1N 3JH | |
Contact: Gill Levitt, MD 44-20-7405-9200 ext. 0073 | |
Queen's Medical Centre | Recruiting |
Nottingham, England, United Kingdom, NG7 2UH | |
Contact: Martin Hewitt, MD, BSc, FRCP, FRCPCH 44-115-924-9924 ext. 63394 martin.hewitt@nuh.nhs.uk | |
Leeds Cancer Centre at St. James's University Hospital | Recruiting |
Leeds, England, United Kingdom, LS9 7TF | |
Contact: Adam Glaser, MD 44-113-206-4984 adam.glaser@leedsth.nhs.uk | |
Leicester Royal Infirmary | Recruiting |
Leicester, England, United Kingdom, LE1 5WW | |
Contact: Mabrouk Madi, MD 44-116-258-5959 | |
Middlesex Hospital | Recruiting |
London, England, United Kingdom, W1T 3AA | |
Contact: Ananth Shankar, MD 44-20-7380-9300 ext. 9950 | |
Oxford Radcliffe Hospital | Recruiting |
Oxford, England, United Kingdom, 0X3 9DU | |
Contact: Kate Wheeler, MD 44-186-522-1066 | |
Institute of Child Health at University of Bristol | Recruiting |
Bristol, England, United Kingdom, BS2 8AE | |
Contact: Pamela Kearns, MD 44-117-342-0205 | |
Royal Liverpool Children's Hospital, Alder Hey | Recruiting |
Liverpool, England, United Kingdom, L12 2AP | |
Contact: Heather P. McDowell, MD 44-151-293-3679 | |
Royal Manchester Children's Hospital | Recruiting |
Manchester, England, United Kingdom, M27 4HA | |
Contact: Bernadette Brennan, MD 44-161-922-2227 bernadette.brennan@cmmc.nhs.uk | |
Royal Marsden - Surrey | Recruiting |
Sutton, England, United Kingdom, SM2 5PT | |
Contact: Mary Taj, MD 44-20-8642-6011 ext. 3089 | |
Sir James Spence Institute of Child Health | Recruiting |
Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP | |
Contact: Juliet Hale, MD 44-191-282-4101 j.p.hale@ncl.ac.uk | |
Southampton General Hospital | Recruiting |
Southampton, England, United Kingdom, SO16 6YD | |
Contact: Janice A. Kohler, MD, FRCP 44-23-8079-6942 | |
Watford General Hospital | Recruiting |
Herts, England, United Kingdom, WD18 0HB | |
Contact: Vasanta Nanduri, MD 44-192-321-7992 | |
United Kingdom, Northern Ireland | |
Royal Belfast Hospital for Sick Children | Recruiting |
Belfast, Northern Ireland, United Kingdom, BT12 6BE | |
Contact: Anthony McCarthy, MD 44-289-063-3631 anthonymcarthy@royalhospital.n.i.nhs.uk | |
United Kingdom, Scotland | |
Royal Aberdeen Children's Hospital | Recruiting |
Aberdeen, Scotland, United Kingdom, AB25 2ZG | |
Contact: Veronica Neefjes 44-1224-550-217 | |
Royal Hospital for Sick Children | Recruiting |
Glasgow, Scotland, United Kingdom, G3 8SJ | |
Contact: Milind D. Ronghe, MD 44-141-201-9309 | |
Royal Hospital for Sick Children | Recruiting |
Edinburgh, Scotland, United Kingdom, EH9 1LF | |
Contact: W. Hamish Wallace, MD 44-131-536-0426 | |
United Kingdom, Wales | |
Childrens Hospital for Wales | Recruiting |
Cardiff, Wales, United Kingdom, CF14 4XW | |
Contact: Heidi Traunecker, MD, PhD 44-29-2074-2285 heidi.traunecker@cardiffandvale.wales.nhs.uk |
Study Chair: | Vasanta Nanduri, MD | Watford General Hospital |
Study ID Numbers: | CDR0000481605, CCLG-LCH-2006-02, EU-20619, UKCCSG-HLH-2004, EUDRACT-2005-002187-28 |
Study First Received: | June 7, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00334672 |
Health Authority: | Unspecified |
hemophagocytic lymphohistiocytosis |
Hemophagocytic lymphohistiocytosis Dexamethasone Hydrocortisone Lymphohistiocytosis, Hemophagocytic Cyclosporine Precancerous Conditions Cortisol succinate Clotrimazole Miconazole Tioconazole Cyclophosphamide Cyclosporins |
Etoposide phosphate Folic Acid Antilymphocyte Serum Lymphatic Diseases Histiocytosis Busulfan Mycophenolate mofetil Methotrexate Hydrocortisone acetate Etoposide Dexamethasone acetate |
Antimetabolites Anti-Inflammatory Agents Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Reproductive Control Agents Hormones Therapeutic Uses Antifungal Agents Abortifacient Agents |
Alkylating Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors Reticuloendotheliosis Antineoplastic Agents, Hormonal Gastrointestinal Agents Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents Myeloablative Agonists |