Advertisement

Topics

Hematopoietic Stem Cell Transplantation (HSCT) Using CD34 Selected Mismatched Related Donor and One Umbilical Cord Unit

2014-07-23 21:11:04 | BioPortfolio

Summary

This study is a means of providing transplantation to those patients who would be a stem cell transplant candidate who do not have an appropriate donor.

The use of CD34 selected haploidentical donor with an umbilical cord unit may help provide earlier engraftment without the need for long term immunosuppression.

This study tests a new method of bone marrow transplantation called combined haploidentical-cord blood transplantation. In this procedure, some of the blood forming cells (the stem cells) from a partially human leukocyte antigen (HLA) matched (haploidentical) related donor are collected from the blood, as well as cells from an umbilical cord are transplanted into the patient (the recipient) after administration of a "conditioning regimen". A conditioning regimen consists of chemotherapy and sometimes radiation to the entire body (total body irradiation, or TBI), which is meant to destroy the cancer cells and suppress the recipient's immune system to allow the transplanted cells to take (grow).

Description

This method of stem cell transplantation is designed to overcome some of the limitations of other alternative donor transplant options. Use of unrelated umbilical cord unit (UCB) donors appears to allow a greater degree of HLA mismatch with acceptable rates of GVHD. However, when UCB transplant was studied in the adult population, investigators discovered several limitations. One major limitation with UCB was delayed engraftment, resulting in higher risk of infection in the early post transplant period. The limitations to cord blood transplant involve delayed engraftment resulting in early complications such as infections. The main limitation associated with haploidentical donors is the significant immunosuppression required to prevent/treat aGVHD. Use of this combined modality of transplantation appears to allow for rapid neutrophil engraftment from the haploidentical donor and coupled with long term hematopoiesis from the UCB donor, thus requiring less long term immunosuppression.

This study tests a new method of bone marrow transplantation called combined haploidentical-cord blood transplantation. In this procedure, some of the blood forming cells (the stem cells) from a partially HLA matched (haploidentical) related donor are collected from the blood, as well as cells from an umbilical cord are transplanted into the patient (the recipient) after administration of a "conditioning regimen". A conditioning regimen consists of chemotherapy and sometimes radiation to the entire body (total body irradiation, or TBI),

One of two 'conditioning regimens' which will be determined by the physician.

1. FLUDARABINE, MELPHALAN, ATG

Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)

2. FLUDARABINE, BUSULFAN, 400 CGY TBI, ATG Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2) 400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)

Day 0 -Haploidentical donor and one umbilical cord blood unit infusion

Filgrastim will be administered daily from day +1 until blood counts have completely recovered. Tacrolimus and another immunosuppressant, Cellcept, starting before transplant also to reduce the risks of graft versus host disease and to promote the growth of the graft. Tacrolimus will be given daily from two days before the transplant until at least three months after transplantation. Cellcept, will be tapered after the cells engraft.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Leukemia, Lymphocytic, Acute

Intervention

Haploidentical/cord transplant

Location

Froedtert Hospital/ Medical College of Wisconsin - Clinical Cancer Center
Milwaukee
Wisconsin
United States
53226

Status

Recruiting

Source

Medical College of Wisconsin

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:04-0400

Clinical Trials [3823 Associated Clinical Trials listed on BioPortfolio]

Haploidentical Hematopoietic Stem Cell Transplantation for Acute Leukemias

This is a prospective observational cohort study of haploidentical transplantation with post-transplant cyclophosphamide for acute leukemias using reduced intensity conditioning for acute ...

The Rapid Study: Randomized Phase II Study To Expedite Allogeneic Transplant With Immediate Haploidentical Plus Unrelated Cord Donor Search Versus Matched Unrelated Donor Search For AML And High-Risk MDS Patients

The study seeks to compare time from formal search to hematopoietic cell transplantation (HCT) for patients 18 years and older, randomized between haplo-cord search and matched unrelated d...

Combined Haploidentical-Cord Blood Transplantation for Adults and Children

The primary objective is to assess the rate of engraftment with combined haploidentical-cord blood transplantation. The secondary objective is to evaluate the incidence and severity of acu...

Randomized Double Cord Blood Transplant Study

Primary objective: In a prospective, phase II randomized study, to evaluate the transplantation of two unmanipulated cord blood units ("double cord blood" transplant) versus one unmanipul...

Haploidentical Lymphocytes With Nivolumab/Ara-C as Consolidation in Elderly AML Patients

A phase II trial to compare the efficacy and safety of nivolumab and intermediate dose cytarabine with or without haploidentical lymphocyte infusion. To identify the role of haploidentical...

PubMed Articles [8935 Associated PubMed Articles listed on BioPortfolio]

Reduced Intensity Allogeneic Transplant for Acute Myeloid Leukemia and Myelodysplastic Syndrome Using Combined CD34-Selected Haploidentical Graft and a Single Umbilical Cord Unit Compared to Matched Unrelated Donor Stem Cells in Older Adults.

Haplo/cord transplantation combines an umbilical cord blood (UCB) graft with CD34-selected haploidentical cells and results in rapid hematopoietic recovery followed by durable UCB engraftment. We comp...

A Modified Post-Transplant Cyclophosphamide (PT-CY) Regimen, for Unmanipulated Haploidentical Marrow Transplantation, in Acute Myeloid Leukemia: a Multicenter Study.

We are reporting a modified post-transplant cyclophosphamide (PT-CY) regimen, for unmanipulated haploidentical marrow transplants (HAPLO), in 150 patients with acute myeloid leukemia (AML). All patien...

Have haploidentical transplants replaced umbilical cord transplants for acute leukemias?

Haploidentical stem cell transplantation (Haplo SCT) and umbilical cord blood stem cell transplantation (UCB SCT) have emerged over the past two to three decades as viable sources of alternative donor...

Haploidentical Transplantation for Older Patients with Acute Myeloid Leukemia and Myelodysplastic Syndrome.

Allogeneic stem cell transplant (ASCT) with HLA matched donors is increasingly used for older patients with AML/MDS. It remains unclear if haploidentical transplantation (haploSCT) is a suitable optio...

Which donor is better when a matched donor is not available domestically? Comparison of outcomes of allogeneic stem cell transplantation with haploidentical and international donors in a homogenous ethnic population.

A substantial proportion of patients requiring allogeneic stem cell transplantation (alloSCT) do not have a human leukocyte antigen-matched sibling donor and need an alternative donor. In this multice...

Medical and Biotech [MESH] Definitions

A chronic leukemia characterized by abnormal B-lymphocytes and often generalized lymphadenopathy. In patients presenting predominately with blood and bone marrow involvement it is called chronic lymphocytic leukemia (CLL); in those predominately with enlarged lymph nodes it is called small lymphocytic lymphoma. These terms represent spectrums of the same disease.

A pathologic change in leukemia in which leukemic cells permeate various organs at any stage of the disease. All types of leukemia show various degrees of infiltration, depending upon the type of leukemia. The degree of infiltration may vary from site to site. The liver and spleen are common sites of infiltration, the greatest appearing in myelocytic leukemia, but infiltration is seen also in the granulocytic and lymphocytic types. The kidney is also a common site and of the gastrointestinal system, the stomach and ileum are commonly involved. In lymphocytic leukemia the skin is often infiltrated. The central nervous system too is a common site.

Enzyme that is a major constituent of kidney brush-border membranes and is also present to a lesser degree in the brain and other tissues. It preferentially catalyzes cleavage at the amino group of hydrophobic residues of the B-chain of insulin as well as opioid peptides and other biologically active peptides. The enzyme is inhibited primarily by EDTA, phosphoramidon, and thiorphan and is reactivated by zinc. Neprilysin is identical to common acute lymphoblastic leukemia antigen (CALLA Antigen), an important marker in the diagnosis of human acute lymphocytic leukemia. There is no relationship with CALLA PLANT.

A chronic leukemia characterized by a large number of circulating prolymphocytes. It can arise spontaneously or as a consequence of transformation of CHRONIC LYMPHOCYTIC LEUKEMIA.

Immunoglobulin preparations used in intravenous infusion, containing primarily IMMUNOGLOBULIN G. They are used to treat a variety of diseases associated with decreased or abnormal immunoglobulin levels including pediatric AIDS; primary HYPERGAMMAGLOBULINEMIA; SCID; CYTOMEGALOVIRUS infections in transplant recipients, LYMPHOCYTIC LEUKEMIA, CHRONIC; Kawasaki syndrome, infection in neonates, and IDIOPATHIC THROMBOCYTOPENIC PURPURA.

More From BioPortfolio on "Hematopoietic Stem Cell Transplantation (HSCT) Using CD34 Selected Mismatched Related Donor and One Umbilical Cord Unit"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Transplantation
Organ transplantation is the moving of an organ from one body to another or from a donor site to another location on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ. The emerging field of regenerative ...

Osteoporosis
Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...


Searches Linking to this Trial