NCT00723099

Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer

Transplantation of Umbilical Cord Blood in Patients With Hematological Malignancies Using a Reduced-Intensity Preparative Regimen (A Multi-Center Trial Coordinated by the FHCRC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 69 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well umbilical cord blood transplant from a donor works in treating patients with hematological cancer. Giving chemotherapy and total-body irradiation (TBI) 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 healthy 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 (called graft-versus-host disease). Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening.

Detailed description

PRIMARY OBJECTIVES: I. Estimate probability of one year survival. II. Demonstrate equivalent or improved engraftment rates with a non-anti-thymocyte globulin (ATG) based conditioning regimen. Patients will be considered graft failure/rejections provided they meet any of the criteria listed below: * Absence of 3 consecutive days with neutrophils \>= 500/ul combined with host cluster of differentiation (CD)3 peripheral blood chimerism \>= 50% at day 42 * Absence of 3 consecutive days with neutrophils \>= 500/ul under any circumstances at day 55 * Death after day 28 with neutrophil count \< 100/ul without any evidence of engraftment (\< 5% donor CD3) * Primary autologous count recovery with \< 5% donor CD3 peripheral blood chimerism at count recovery and without relapse SECONDARY OBJECTIVES: I. Six month non-relapse mortality. II. Overall incidence of graft failure/rejection. Patients will be considered graft failure/rejections provided they meet any of the criteria listed below: * Absence of 3 consecutive days with neutrophils \>= 500/ul combined with host CD3 peripheral blood chimerism \>= 50% at day 42 * Absence of 3 consecutive days with neutrophils \>= 500/ul under any circumstances at day 55 * Death after day 28 with neutrophil count \< 100/ul without any evidence of engraftment (\< 5% donor CD3) * Primary autologous count recovery with \< 5% donor CD3 peripheral blood chimerism at count recovery and without relapse III. Kinetics of chimeric reconstitution. IV. Incidence of neutrophil engraftment by day 42. V. Incidence of platelet engraftment by six months. VI. Incidence of grade II-IV and III-IV acute graft-versus-host disease (GvHD) at day 100. VII. Incidence of one year chronic GvHD. VIII. Incidence of clinically significant infections at 6 months, 1 year, 2 years. IX. Probability of one and two year survival. X. Incidence of one and two year relapse or disease progression. XI. Fred Hutchinson Cancer Research Center (FHCRC) patients: Kinetics of immune reconstitution, with both functional and quantitative assays. XII. FHCRC patients: Examination of possible immunologic factors leading to emergence of a dominant unit. OUTLINE: CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients undergo a lower dose of total-body irradiation (TBI) on day -1. UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0. IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days -3 to +180 and mycophenolate mofetil IV or orally (PO) every 8 hours on days 0 to +96. After completion of study treatment, patients are followed periodically for up to 2 years.

Conditions

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Aggressive Non-Hodgkin Lymphoma
• Chronic Myelogenous Leukemia
• Chronic Phase Chronic Myelogenous Leukemia
• Indolent Non-Hodgkin Lymphoma
• Lymphoma
• Mixed Phenotype Acute Leukemia
• Myelodysplastic Syndrome
• Myeloproliferative Neoplasm
• Recurrent Chronic Lymphocytic Leukemia
• Recurrent Follicular Lymphoma
• Recurrent Lymphoplasmacytic Lymphoma
• Recurrent Mantle Cell Lymphoma
• Recurrent Marginal Zone Lymphoma
• Recurrent Plasma Cell Myeloma
• Recurrent Small Lymphocytic Lymphoma
• Recurrent T-Cell Non-Hodgkin Lymphoma
• Refractory Chronic Lymphocytic Leukemia
• Refractory Chronic Myelogenous Leukemia
• Refractory Follicular Lymphoma
• Refractory Hodgkin Lymphoma
• Refractory Lymphoplasmacytic Lymphoma
• Refractory Mantle Cell Lymphoma
• Refractory Small Lymphocytic Lymphoma
• T-Cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
PROCEDURE	Allogeneic Hematopoietic Stem Cell Transplantation	Undergo umbilical cord blood transplant
DRUG	Cyclophosphamide	Given IV
DRUG	Cyclosporine	Given IV
DRUG	Fludarabine Phosphate	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Mycophenolate Mofetil	Given IV or PO
RADIATION	Total-Body Irradiation	Undergo TBI
PROCEDURE	Umbilical Cord Blood Transplantation	Undergo umbilical cord blood transplant

Timeline

• Start date: 2008-06-25
• Primary completion: 2018-07-31
• Completion: 2018-07-31
• First posted: 2008-07-28
• Last updated: 2019-12-27
• Results posted: 2019-10-11

Locations

6 sites across 1 country: United States