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Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer

This study has been terminated.
(Replaced with another study)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00290628
First received: February 9, 2006
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  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

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Transplantation of Umbilical Cord Blood From Related and Unrelated Donors

Resource links provided by NLM:

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

Further study details as provided by Masonic Cancer Center, University of Minnesota:
Enrollment: 43
Study Start Date: October 1999
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility
Ages Eligible for Study:   up to 45 Years   (Child, Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
National Cancer Institute (NCI)
Investigators
Study Chair: John E. Wagner, MD Masonic Cancer Center, University of Minnesota
  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 
Study First Received: February 9, 2006
Last Updated: October 9, 2012
Health Authority: United States: Federal Government

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
Leukemia
Syndrome
Multiple Myeloma
Neoplasms, Plasma Cell
Anemia
Myelodysplastic Syndromes
Preleukemia
Graft vs Host Disease
Plasmacytoma
Myeloproliferative Disorders
Anemia, Diamond-Blackfan
Myelodysplastic-Myeloproliferative Diseases
Fanconi Anemia
Fanconi Syndrome
 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

ClinicalTrials.gov processed this record on September 29, 2016