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Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00290628
  Purpose

RATIONALE: Giving chemotherapy and total-body irradiation 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 stem cells from a related or unrelated donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow to make stem cells, red blood cells, white blood cells, and platelets.

PURPOSE: This clinical trial is studying how well donor umbilical cord blood transplant works in treating patients with hematologic cancer.


Condition Intervention
Chronic Myeloproliferative Disorders
Diamond-Blackfan Anemia
Fanconi Anemia
Graft Versus Host Disease
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Drug: anti-thymocyte globulin
Drug: busulfan
Drug: cyclophosphamide
Drug: cyclosporine
Drug: filgrastim
Drug: melphalan
Drug: methylprednisolone
Drug: mycophenolate mofetil
Procedure: radiation therapy
Procedure: umbilical cord blood transplantation

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Anemia Cancer Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma
Drug Information available for: Cyclophosphamide Filgrastim Methylprednisolone Melphalan Cyclosporin Cyclosporine Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Melphalan hydrochloride Sarcolysin Busulfan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Transplantation of Umbilical Cord Blood From Related and Unrelated Donors

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 60
Study Start Date: March 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:

    • Leukemia including, but not limited to, the following subtypes:

      • Chronic myelogenous leukemia
      • Acute myeloid leukemia (primary or secondary)
      • Acute lymphoblastic leukemia
    • Lymphoma
    • Myelodysplastic syndrome
    • Aplastic anemia
    • Fanconi's anemia
    • Diamond-Blackfan anemia
    • Inborn errors of metabolism (e.g., Hurler syndrome, Maroteaux-Lamy syndrome, myelodysplastic syndrome VI, metachromatic leukodystrophy, adrenoleukodystrophy, and globoid cell leukodystrophy)
    • Immune deficiency disorders
  • Patients must meet the eligibility requirements outlined in currently active treatment protocols of the University of Minnesota Bone Marrow Transplant Program
  • HLA-identical or 1, 2, or 3 antigen mismatched umbilical cord blood (UCB) donor with at least one DRB1 match available

    • Unrelated or related donor
    • UCB specimen must contain ≥ 2.0 x 10^7 nucleated cells/kg patient body weight

PATIENT CHARACTERISTICS:

  • See Disease Characteristics
  • No active infection
  • No history of HIV infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290628

Locations
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Study Chair: John E. Wagner, MD Masonic Cancer Center, University of Minnesota
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000450845, UMN-2000LS017, UMN-MT1999-28
Study First Received: February 9, 2006
Last Updated: November 16, 2008
ClinicalTrials.gov Identifier: NCT00290628  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
graft versus host disease
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
accelerated phase chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
atypical chronic myeloid leukemia
blastic phase chronic myelogenous leukemia
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood chronic myelogenous leukemia
chronic eosinophilic leukemia
chronic idiopathic myelofibrosis
chronic myelomonocytic leukemia
chronic neutrophilic leukemia
chronic phase chronic myelogenous leukemia
de novo myelodysplastic syndromes
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
juvenile myelomonocytic leukemia
myelodysplastic/myeloproliferative disease, unclassifiable
nodal marginal zone B-cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma

Study placed in the following topic categories:
Blast Crisis
Sezary syndrome
Cyclosporine
Chronic myelogenous leukemia
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Cyclosporins
Small non-cleaved cell lymphoma
Lymphoma, large-cell, immunoblastic
Preleukemia
Hemorrhagic Disorders
Neoplasm Metastasis
Myelodysplastic syndromes
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Metabolic Diseases
Hematologic Diseases
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Leukemia, Myelomonocytic, Chronic
Blood Coagulation Disorders
Acute myelogenous leukemia
Leukemia, Myeloid
Myelodysplastic myeloproliferative disease
Leukemia, Myeloid, Accelerated Phase
B-cell lymphomas
Lymphoma, Non-Hodgkin
Hairy cell leukemia
Precancerous Conditions
Blood Protein Disorders
Lymphoma, Follicular
Sezary Syndrome

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
DNA Repair-Deficiency Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Neuroprotective Agents
Pathologic Processes
Syndrome
Therapeutic Uses
Antifungal Agents
Cardiovascular Diseases
Alkylating Agents
Dermatologic Agents
Disease
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Glucocorticoids
Protective Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Anemia, Hypoplastic, Congenital

ClinicalTrials.gov processed this record on January 16, 2009