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Transplantation of Umbilical Cord Blood From Related and Unrelated Donors


N/A
N/A
45 Years
Not Enrolling
Both
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

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Trial Information

Transplantation of Umbilical Cord Blood From Related and Unrelated Donors


OBJECTIVES:

Primary

- Determine the engraftment potential of umbilical cord blood (UCB) in patients with
hematological cancers.

- Determine the safety of UCB transplantation in these patients.

Secondary

- Determine the rate of neutrophil and platelet recovery and the completeness of donor
cell engraftment.

- Determine the incidence and severity of acute and chronic graft-versus-host disease.

- Determine the incidence of relapse in patients with malignant disease.

- Determine the probabilities of survival and event-free survival (EFS) at 1 and 2 years
after UCB transplantation.

OUTLINE: Patients are stratified according to degree of HLA disparity (0-1 vs 2-3
disparities between donor and recipient), donor type (related vs unrelated), and the basis
of cell dose (< 2 vs ≥ 2 x 10^7 nucleated cells/kg recipient body weight). Patients are
assigned to 1 of 4 treatment groups according to disease*.

NOTE: *Patients with acute lymphocytic leukemia (ALL), secondary acute myeloid leukemia
(AML), severe combined immunodeficiency, familial erythrophagocytic lymphohistiocytosis
(FEL)/viral-associated hemophagocytic syndrome (VAHS), inborn errors of metabolism, aplastic
anemia, Fanconi's anemia, or Diamond-Blackfan anemia who have an unrelated umbilical cord
blood donor may proceed directly to transplantation.

- Preparative regimen:

- Group 1 (patients with chronic myelogenous leukemia, AML, myelodysplastic
syndromes, or ALL): Patients receive cyclophosphamide IV once daily on days -7 and
-6. Patients then undergo total-body irradiation (TBI) twice daily on days -4 to
-1. Patients undergoing unrelated allogeneic umbilical cord blood transplantation
(UCBT) also receive methylprednisone IV and anti-thymocyte globulin (ATG) IV twice
daily on days -2 and -1.

- Group 2 (patients with infant leukemia): Patients receive busulfan orally or IV
four times daily on days -9 to -6 and melphalan IV once daily on days -4 to -2.
Patients undergoing unrelated allogeneic UCBT also receive methylprednisolone IV
and ATG IV twice daily on days -2 and -1.

- Group 3 (patients with inborn errors of metabolism): Patients receive busulfan
orally or IV four times daily on days -9 to -6 and cyclophosphamide IV once daily
on days -5 to -2. Patients undergoing unrelated allogeneic UCBT also receive
methylprednisolone IV and ATG IV twice daily on days -2 and -1.

- Group 4 (patients with aplastic anemia): Patients receive cyclophosphamide IV once
daily on days -6 to -3 and ATG IV twice daily on days -5 and -3. Patients then
undergo TBI once on day -2.

- Allogeneic UCBT: Patients undergo UCBT on day 0. Patients with inborn errors of
metabolism receive methylprednisolone IV before and after UCBT on day 0.

- Graft-versus-host disease (GVHD) prophylaxis: Patients receive 1 of the following
regimens:

- Related donor UCBT: Patients receive cyclosporine IV over 2 hours or orally
beginning on day -3 and continuing until day 60.

- Unrelated donor UCBT and myeloablative preparative regimen: Patients receive
cyclosporine orally or IV over 2 hours twice daily beginning on day -3 and
continuing until day 180. Patients also receive methylprednisolone IV twice daily
on days 5-19.

- Unrelated donor UCBT and nonmyeloablative preparative regimen: Patients receive
cyclosporine IV over 2 hours or orally twice daily beginning on day -3 and
continuing until day 180. Patients also receive mycophenolate mofetil IV or orally
beginning on day 5 and continuing until day 30 or 7 days after active GVHD is
controlled.

All patients receive filgrastim (G-CSF) IV beginning on day 1 and continuing until blood
counts recover.

Patients are followed periodically for 2 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

John E. Wagner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Federal Government

Study ID:

2000LS017

NCT ID:

NCT00290628

Start Date:

October 1999

Completion Date:

April 2007

Related Keywords:

  • 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
  • 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
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • previously treated myelodysplastic syndromes
  • recurrent adult acute lymphoblastic leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult Burkitt lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • recurrent childhood large cell lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • recurrent small lymphocytic lymphoma
  • refractory chronic lymphocytic leukemia
  • refractory hairy cell leukemia
  • refractory multiple myeloma
  • relapsing chronic myelogenous leukemia
  • secondary acute myeloid leukemia
  • secondary myelodysplastic syndromes
  • splenic marginal zone lymphoma
  • stage III adult Burkitt lymphoma
  • stage III adult Hodgkin lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III chronic lymphocytic leukemia
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III mantle cell lymphoma
  • stage III marginal zone lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV adult Burkitt lymphoma
  • stage IV adult Hodgkin lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV chronic lymphocytic leukemia
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV mantle cell lymphoma
  • stage IV marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • Diamond-Blackfan anemia
  • Fanconi anemia
  • childhood myelodysplastic syndromes
  • 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

Name

Location

University of Minnesota Cancer CenterMinneapolis, Minnesota  55455