Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Graft vs Host Disease

Neoplasms by Histologic Type

Hematologic Diseases

Homologous Wasting Disease

Antineoplastic Agents

All Drugs and Chemicals

Fludarabine

Fludarabine phosphate

Thymoglobulin

Busulfan

Antilymphocyte Serum

Immunosuppressive Agents

Immunologic Factors

Alkylating Agents

Antineoplastic Agents, Alkylating

All patients on this trial will receive a conditioning regimen of Busulfan, Fludarabine, Anti-Thymocyte Globulin and Total Body Irradiation (400 cGy)

Patient will receive a Test Dose of Busulfan on either Day -10 or Day -9. Patient will receive their Regimen Dose of Busulfan on Day -5 to Day -2. The regimen dose of Busulfan will be based off of the findings from their Test Dose.

Patient will receive Fludarabine from Day -6 to Day -2. The dose of Fludarabine will be 30 mg/m\^2/day.

The patient will also receive Thymoglobulin (rabbitATG) on Day -4 to Day -2. Each dose of rabbitATG will be 1.5 mg/kg/day.

On Day -1 the patient will receive a total of 400 cGy of Total Body Irradiation.

Total Body Irradiation

Sonali Chaudhury, MD

Colleen E Rosen, BS, RN

The study proposes the use of Fludarabine, Busulfan, Anti Thymocyte Globulin Rabbit (ATG) and Total Body Irradiation as a preparative regimen before hematopoietic stem cell transplant from unrelated donor peripheral blood stem cells (PBSC). The hypothesis states that the 100 day mortality after this type of transplant will be significantly below the accepted standards, which is about 30% for unrelated donors.

The primary objective of this study is to evaluate the toxicity (as measured as 100 day survival) after hematopoietic stem cell transplant from an unrelated donor with a novel preparative regimen of Fludarabine, Busulfan, Anti-Thymocyte Globulin, and Total Body Irradiation for pediatric patients with leukemia. The secondary objectives are to evaluate the relapse-free and overall survival after hematopoietic stem cell transplant as well as to evaluate the incidence of acute and chronic graft-versus-host disease after this preparative regimen.

Allogeneic Transplantation for Pediatric Leukemias With Unrelated Donors

Allogeneic Transplantation for Pediatric Leukemias With Unrelated Donors Using Fludarabine, Busulfan, 400 cGy Total Body Irradiation, and Thymoglobulin

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Allogeneic Transplantation for Pediatric Leukemias With Unrelated Donors	NCT00679536	Leukemia	Busulfan Fludarabine Thymoglobulin Total Body Irra...	- 21 Years	Ann & Robert H Lurie Children's Hospital of Chicago
Allogeneic Transplantation for Pediatric Leukemias With Unrelated Donors	NCT00679536	Leukemia	Busulfan Fludarabine Thymoglobulin Total Body Irra...	- 21 Years	Ann & Robert H Lurie Children's Hospital of Chicago

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