Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

This study is currently recruiting participants.
Verified August 2012 by Case Comprehensive Cancer Center

First Received on March 24, 2010.  
Last Updated on August 2, 2012  
History of Changes
This Clinical Trial Sponsored By: Case Comprehensive Cancer Center
Information provided by (Responsible Party): Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01093586
 

Purpose for Clinical Trial

RATIONALE: Giving chemotherapy 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 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.

Condition Study Intervention Clinical Trial Phase
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
Procedure: double-unit umbilical cord blood transplantation
Other: cytogenetic analysis
Procedure: bone marrow aspiration
Other: fluorescence in situ hybridization
Drug: busulfan
Drug: cyclophosphamide
Drug: anti-thymocyte globulin
Drug: methylprednisolone
Drug: cyclosporine
Drug: mycophenolate mofetil
Other: flow cytometry
Procedure: allogeneic hematopoietic stem cell transplantation
Phase 2

Study Type: Study Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Umbilical Cord Blood (UCB) Allogeneic Stem Cell Transplant for Hematologic Malignancies

Resource links provided by NLM:

Genetics Home Reference related topics:
aceruloplasminemia
familial acute myeloid leukemia with mutated CEBPA
hemophilia
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Fungal Infections
Leukemia
Lymphoma
Myelodysplastic Syndromes
Drug Information available for:
Cyclophosphamide
Prednisolone
Prednisolone acetate
Methylprednisolone acetate

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