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Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer

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ClinicalTrials.gov Identifier: NCT00290628
Recruitment Status : Terminated (Replaced with another study)
First Posted : February 13, 2006
Last Update Posted : November 29, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
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 Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transplantation of Umbilical Cord Blood From Related and Unrelated Donors
Study Start Date : October 1999
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Childhood Acute Lymphoblastic Leukemia Burkitt Lymphoma Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic Syndromes Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Lymphosarcoma Multiple Myeloma Hairy Cell Leukemia Follicular Lymphoma B-cell Lymphoma Mantle Cell Lymphoma Diffuse Large B-Cell Lymphoma Hodgkin Lymphoma Hodgkin Lymphoma, Childhood Marginal Zone Lymphoma Homologous Wasting Disease Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Cutaneous T-cell Lymphoma Chronic Myeloid Leukemia Myelofibrosis Chronic Myeloproliferative Disorders Fanconi Anemia Congenital Aplastic Anemia Fanconi Syndrome Mycosis Fungoides Lymphoma, Large-cell Myelodysplastic/myeloproliferative Disease Sezary Syndrome Lymphoblastic Lymphoma Diamond-Blackfan Anemia Plasmacytoma Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Chronic Neutrophilic Leukemia Nephropathic Cystinosis Primary Fanconi Syndrome Pure Red Cell Aplasia
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290628


Locations
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI)
Investigators
Study Chair: John E. Wagner, MD Masonic Cancer Center, University of Minnesota
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00290628     History of Changes
Other Study ID Numbers: 2000LS017
UMN-MT1999-28
First Posted: February 13, 2006    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017

Keywords provided by Masonic Cancer Center, University of Minnesota:
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

Additional relevant MeSH terms:
Lymphoma
Syndrome
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Anemia
Myelodysplastic Syndromes
Preleukemia
Graft vs Host Disease
Plasmacytoma
Myeloproliferative Disorders
Fanconi Anemia
Fanconi Syndrome
Myelodysplastic-Myeloproliferative Diseases
Anemia, Diamond-Blackfan
 Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders