Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
|ClinicalTrials.gov Identifier: NCT01093586|
Recruitment Status : Completed
First Posted : March 26, 2010
Last Update Posted : December 21, 2015
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.
|Condition or disease||Intervention/treatment||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|
1. To establish the day +180 overall survival after a myeloablative unrelated double unit UCBT in a single institution setting.
- To determine the rates of hematologic and immune reconstitution in patients with high risk hematologic malignancies, who are undergoing myeloablative chemotherapy followed by infusion of double unit UCBT.
- To determine the contribution of each umbilical cord unit to immune reconstitution with a focus on both initial (day +21 BM, and +28 PB) and sustained engraftment (day +100 BM; PB at +14, +21, +28, +35, +42, +60, +100, +180, +1 and 2 years).
- To determine the probability of overall survival and disease free survival at one and two years.
- To describe the incidence of disease recurrence at one and two years in patients post UCBT.
- To describe the incidence of acute GVHD and chronic GVHD at 100 days and at one year, respectively.
- To determine the incidence of day 100 and 180 treatment related mortality.
- To determine the incidence of serious infectious complications in the first year after transplant.
- To determine the incidence of donor-derived neutrophil and platelet recovery.
- To determine the incidence of secondary lymphoproliferative diseases following transplantation with umbilical cord blood.
PREPARATIVE REGIMEN: Patients receive oral busulfan every 6 hours on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1.
TRANSPLANTATION: Patients undergo double-unit umbilical cord blood allogeneic stem cell transplantation on day 0.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally every 8 hours on days -3 to 45. After completion of study treatment, patients are followed periodically.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Umbilical Cord Blood (UCB) Allogeneic Stem Cell Transplant for Hematologic Malignancies|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Arm I
PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
Procedure: double-unit umbilical cord blood transplantation
Undergo transplantationOther: cytogenetic analysis
Correlative studiesProcedure: bone marrow aspiration
Correlative studiesOther: fluorescence in situ hybridization
Other Name: fluorescence in situ hybridization (FISH)Drug: busulfan
Other Names:Drug: cyclophosphamide
Other Names:Drug: anti-thymocyte globulin
Other Names:Drug: methylprednisolone
Other Names:Drug: cyclosporine
Other Names:Drug: mycophenolate mofetil
Given orally or IV
Other Names:Other: flow cytometry
Correlative studiesProcedure: allogeneic hematopoietic stem cell transplantation
- Overall survival [ Time Frame: On day +180 ]
- Hematologic engraftment [ Time Frame: On day +42 ]
- Disease-free and overall survival [ Time Frame: At 1 and 2 years ]
- Duration of response [ Time Frame: one and two years ]
- Transplant related mortality [ Time Frame: On day 100 and 180 ]
- Recurrence or relapse [ Time Frame: one and two years in patients post UCBT ]
- Occurrence of serious infections [ Time Frame: 1 year ]
- Immune reconstitution [ Time Frame: Periodically for 2 years ]
- Toxicity related to UCB transplantation and cytoreduction as assessed by CTC v3.0 [ Time Frame: three consecutive measurements on different days by day +42 ]
- Incidence of acute graft-versus-host disease (GVHD) [ Time Frame: At 100 days ]
- Incidence of chronic GVHD [ Time Frame: At 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093586
|United States, Ohio|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Brenda Cooper, MD||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|