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Cord Blood Transplantation for Hematologic Malignancies and Bone Marrow Failure Syndromes


Phase 2
5 Years
50 Years
Open (Enrolling)
Both
Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes

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Trial Information

Cord Blood Transplantation for Hematologic Malignancies and Bone Marrow Failure Syndromes


OBJECTIVES: I. Determine the safety, efficacy, and toxicity of using cord blood as a source
for stem cell transplantation in patients with hematologic malignancies.

OUTLINE: Patients undergo autologous bone marrow harvesting or peripheral stem cell
collection prior to transplant regimen, unless the patient has acute leukemia in relapse,
aplastic anemia, or myelodysplastic syndrome. Arm I: Patients eligible to undergo total body
irradiation (TBI) first receive cyclophosphamide IV over 2 hours on days -5 and -4, then
undergo TBI twice a day on days -3 to -1. Patients also receive antithymocyte globulin (ATG)
IV over 10 hours on days -3 to -1. Cord blood is infused on day 0. Arm II: Patients not
eligible to receive TBI receive oral busulfan every 6 hours on days -7 to -4 for a total of
16 doses. Cyclophosphamide, ATG, and cord blood are then administered as in arm I. All
patients receive cyclosporine on days -2 to 180, methylprednisolone on days 5-180, and
filgrastim (G-CSF) from day 1. Patients are followed weekly until day 180 and then monthly
for 2 years.

PROJECTED ACCRUAL: A total of 20 patients (10 patients per arm) will be accrued for this
study within 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven hematologic malignancy Acute lymphocytic
leukemia (ALL): In second or later remission In first remission with poor prognostic
features (Philadelphia chromosome positive) Acute myeloid leukemia (AML): In second or
later remission In first remission with poor prognostic features, e.g., Arising from
myelodysplastic syndrome Cytogenetics with -5, -7, +8, 11q23 abnormalities Complex
cytogenetics AML or ALL refractory to induction or in relapse Myelodysplastic syndrome
Chronic myelogenous leukemia Severe aplastic anemia or Fanconi's anemia Relapsed Hodgkin's
disease Relapsed non-Hodgkin's lymphoma Multiple myeloma No suitable family donor matched
for 5 or 6 HLA antigens (A, B, DR) No suitable unrelated donor matched for 6 HLA antigens
Cord blood donor available matched for 4-6 out of 6 HLA antigens

PATIENT CHARACTERISTICS: Age: 5 to 50 Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3
times normal Alkaline phosphatase less than 3 times normal SGOT less than 3 times normal
Renal: Creatinine less than 2 times normal OR Creatinine clearance greater than 60 mL/min
Cardiovascular: MUGA with ejection fraction at least 50% Pulmonary: DLCO and spirometry at
least 60% OR Exercise VO2 max/kg at least 15 mL/min/kg Other: HIV antibody negative
Hepatitis B surface antigen negative No active bacterial, viral, or fungal infection

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed If following
limits have not been exceeded, patient may receive total body irradiation: No prior
radiation to one entire kidney Whole liver received no greater than 1000 cGy No prior
whole abdomen radiotherapy Small bowel received no greater than 3000 cGy Heart received no
greater than 1800 cGy No prior whole lung radiotherapy CNS received less than 30 cGy
(whole brain or any portion of the spine) Surgery: Not specified

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety, efficacy and toxicity of using cord blood as a source for stem cell transplantation in patients with hematologic malignancies.

Outcome Time Frame:

weekly until day 100+, then yearly

Safety Issue:

Yes

Principal Investigator

Barbara Jean Bambach, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000066168

NCT ID:

NCT00003270

Start Date:

September 1997

Completion Date:

Related Keywords:

  • Graft Versus Host Disease
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent adult Hodgkin lymphoma
  • Burkitt lymphoma
  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • childhood diffuse large cell lymphoma
  • childhood immunoblastic large cell lymphoma
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • meningeal chronic myelogenous leukemia
  • adult acute myeloid leukemia in remission
  • adult acute lymphoblastic leukemia in remission
  • childhood acute myeloid leukemia in remission
  • childhood acute lymphoblastic leukemia in remission
  • recurrent/refractory childhood Hodgkin lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • secondary acute myeloid leukemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • graft versus host disease
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • childhood myelodysplastic syndromes
  • Neoplasms
  • Graft vs Host Disease
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263