Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer
This study has been terminated.
(Replaced with another study)
Sponsor:
Masonic Cancer Center, University of Minnesota
Collaborator:
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
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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:
Genetics Home Reference related topics:
Diamond-Blackfan anemia
familial acute myeloid leukemia with mutated CEBPA
Fanconi anemia
mycosis fungoides
Sézary syndrome
MedlinePlus related topics:
Acute Myeloid Leukemia
Anemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Hodgkin Disease
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
Drug Information available for:
Cyclophosphamide
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Busulfan
Methylprednisolone
Prednisolone sodium phosphate
Melphalan
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
Melphalan hydrochloride
Mycophenolic acid
Mycophenolate sodium
Cyclosporine
Mycophenolate mofetil hydrochloride
Filgrastim
Mycophenolate mofetil
Lenograstim
Granulocyte colony-stimulating factor
Antilymphocyte Serum
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 |
| 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
No publications provided
| 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:
|
Anemia Neoplasms Fanconi Anemia Fanconi Syndrome Graft vs Host Disease Leukemia Lymphoma Lymphoma, Non-Hodgkin Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Lymphoma, Large-Cell, Immunoblastic |
Anemia, Diamond-Blackfan Myelodysplastic-Myeloproliferative Diseases Hematologic Diseases Anemia, Hypoplastic, Congenital Anemia, Aplastic Bone Marrow Diseases Genetic Diseases, Inborn DNA Repair-Deficiency Disorders Metabolic Diseases Kidney Diseases Urologic Diseases Renal Tubular Transport, Inborn Errors Metabolism, Inborn Errors Immune System Diseases Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 16, 2013