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Sponsors and Collaborators: |
Masonic Cancer Center, University of Minnesota National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00618540 |
RATIONALE: Giving a monoclonal antibody, such as alemtuzumab, and chemotherapy drugs, such as fludarabine and melphalan, before a donor stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells and helps stop the growth of abnormal 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 before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving alemtuzumab together with fludarabine and melphalan followed by a donor stem cell transplant works in treating young patients with resistant Langerhans cell histiocytosis.
Condition | Intervention | Phase |
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Langerhans Cell Histiocytosis |
Drug: alemtuzumab Drug: fludarabine phosphate Drug: melphalan Drug: therapeutic allogeneic lymphocytes Procedure: allogeneic bone marrow transplantation Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Procedure: umbilical cord blood transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Reduced Intensity Hematopoietic Cell Transplantation for Patients With Resistant Langerhans Cell Histiocytosis |
Estimated Enrollment: | 25 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
After completion of study therapy, patients are followed from engraftment through day 100, and then at 6 months, 1 year, and annually thereafter for 2-5 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Considered poor-risk, defined as multisystem disease with involvement of one or more risk organs (i.e., liver, spleen, lungs, and/or hematopoietic system)
Progressive disease after one of the following treatments:
HLA-matched related or unrelated donor OR unrelated umbilical cord blood (UCB) available
PATIENT CHARACTERISTICS:
Adequate hepatic, renal, cardiac, and pulmonary function to undergo reduced-intensity hematopoietic cell transplantation (RI-HCT) including the following:
PRIOR CONCURRENT THERAPY:
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 |
Study Chair: | K. Scott Baker, MD | Masonic Cancer Center, University of Minnesota |
Responsible Party: | Masonic Cancer Center at University of Minnesota ( K. Scott Baker ) |
Study ID Numbers: | CDR0000587357, UMN-2007UC002, UMN-MT2006-07, UMN-0612M98407 |
Study First Received: | February 19, 2008 |
Last Updated: | October 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00618540 |
Health Authority: | Unspecified |
Langerhans cell histiocytosis |
Melphalan Lung Diseases, Interstitial Langerhans cell histiocytosis Fludarabine monophosphate Histiocytosis, Langerhans-Cell Histiocytosis X Lymphatic Diseases |
Letterer-Siwe disease Histiocytosis Respiratory Tract Diseases Lung Diseases Alemtuzumab Fludarabine |
Antimetabolites Reticuloendotheliosis Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Alkylating Agents |