Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
NCT01093586 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2019-01-23
Summary
RATIONALE: Giving chemotherapy before a donor umbilical cord blood transplant (UCBT) 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 an unrelated donor, that do not exactly match the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well donor umbilical cord blood stem cell transplant works in treating patients with hematologic malignancies.
Conditions
- Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
- Adult Acute Lymphoblastic Leukemia in Remission
- Adult Acute Megakaryoblastic Leukemia (M7)
- Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
- Adult Acute Monoblastic Leukemia (M5a)
- Adult Acute Monocytic Leukemia (M5b)
- Adult Acute Myeloid Leukemia in Remission
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Adult Erythroleukemia (M6a)
- Adult Nasal Type Extranodal NK/T-cell Lymphoma
- Adult Pure Erythroid Leukemia (M6b)
- B-cell Adult Acute Lymphoblastic Leukemia
- B-cell Childhood Acute Lymphoblastic Leukemia
- Blastic Phase Chronic Myelogenous Leukemia
- Burkitt Lymphoma
- Childhood Acute Erythroleukemia (M6)
- Childhood Acute Lymphoblastic Leukemia in Remission
- Childhood Acute Megakaryocytic Leukemia (M7)
- Childhood Acute Minimally Differentiated Myeloid Leukemia (M0)
- Childhood Acute Monoblastic Leukemia (M5a)
- Childhood Acute Monocytic Leukemia (M5b)
- Childhood Acute Myeloid Leukemia in Remission
- Childhood Chronic Myelogenous Leukemia
- Childhood Diffuse Large Cell Lymphoma
- Childhood Immunoblastic Large Cell Lymphoma
- Childhood Myelodysplastic Syndromes
- Childhood Nasal Type Extranodal NK/T-cell Lymphoma
- Chronic Myelomonocytic Leukemia
- Chronic Phase Chronic Myelogenous Leukemia
- Cutaneous B-cell Non-Hodgkin Lymphoma
- de Novo Myelodysplastic Syndromes
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Juvenile Myelomonocytic Leukemia
- Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
- Nodal Marginal Zone B-cell Lymphoma
- Previously Treated Myelodysplastic Syndromes
- Prolymphocytic Leukemia
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent Adult Acute Myeloid Leukemia
- Recurrent Adult Burkitt Lymphoma
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Diffuse Mixed Cell Lymphoma
- Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
- Recurrent Adult Grade III Lymphomatoid Granulomatosis
- Recurrent Adult Immunoblastic Large Cell Lymphoma
- Recurrent Adult Lymphoblastic Lymphoma
- Recurrent Childhood Acute Lymphoblastic Leukemia
- Recurrent Childhood Acute Myeloid Leukemia
- Recurrent Childhood Anaplastic Large Cell Lymphoma
- Recurrent Childhood Grade III Lymphomatoid Granulomatosis
- 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
- Relapsing Chronic Myelogenous Leukemia
- Secondary Acute Myeloid Leukemia
- Secondary Myelodysplastic Syndromes
- Secondary Myelofibrosis
- Splenic Marginal Zone Lymphoma
- Stage I Chronic Lymphocytic Leukemia
- Stage II Chronic Lymphocytic Leukemia
- Stage III Chronic Lymphocytic Leukemia
- Stage IV Chronic Lymphocytic Leukemia
- T-cell Adult Acute Lymphoblastic Leukemia
- T-cell Childhood Acute Lymphoblastic Leukemia
- T-cell Large Granular Lymphocyte Leukemia
- Waldenstrom Macroglobulinemia
Interventions
- PROCEDURE
-
double-unit umbilical cord blood transplantation
Undergo transplantation
- OTHER
-
cytogenetic analysis
Correlative studies
- PROCEDURE
-
bone marrow aspiration
Correlative studies
- OTHER
-
fluorescence in situ hybridization
Correlative studies
- DRUG
-
busulfan
Given orally
- DRUG
-
Given IV
- DRUG
-
anti-thymocyte globulin
Given IV
- DRUG
-
methylprednisolone
Given IV
- DRUG
-
cyclosporine
Given IV
- DRUG
-
mycophenolate mofetil
Given orally or IV
- OTHER
-
flow cytometry
Correlative studies
- PROCEDURE
-
allogeneic hematopoietic stem cell transplantation
Undergo transplantation
Sponsors & Collaborators
-
Case Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Brenda Cooper, MD · Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-09-30
- Primary Completion
- 2015-12-31
- Completion
- 2015-12-31
Countries
- United States
Study Locations
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