Allogeneic Transplantation for Pediatric Leukemias With Unrelated Donors
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|ClinicalTrials.gov Identifier: NCT00679536|
Recruitment Status : Unknown
Verified January 2014 by Sonali Chaudhury, MD, Ann & Robert H Lurie Children's Hospital of Chicago.
Recruitment status was: Recruiting
First Posted : May 19, 2008
Last Update Posted : January 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: Busulfan Drug: Fludarabine Drug: Thymoglobulin Radiation: Total Body Irradiation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Allogeneic Transplantation for Pediatric Leukemias With Unrelated Donors Using Fludarabine, Busulfan, 400 cGy Total Body Irradiation, and Thymoglobulin|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||May 2015|
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.
Other Name: IV Busulfex
Patient will receive Fludarabine from Day -6 to Day -2. The dose of Fludarabine will be 30 mg/m^2/day.
Other Name: Fludara
The patient will also receive Thymoglobulin (rabbitATG) on Day -4 to Day -2. Each dose of rabbitATG will be 1.5 mg/kg/day.
Radiation: Total Body Irradiation
On Day -1 the patient will receive a total of 400 cGy of Total Body Irradiation.
- To evaluate the toxicity (as measures by 100 day survival) after hematopoietic stem cell transplant from an unrelated donor with a novel preparative regimen. [ Time Frame: 100 day mortality ]
- To evaluate the relapse-free and overall survival after hematopoietic stem cell transplant with Fludarabine/Busulfan/ATG/TBI preparative regimen for pediatric patients with leukemia. [ Time Frame: 5 years ]
- To evaluate the incidence of acute and chronic graft-versus-host disease after hematopoietic stem cell transplant [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00679536
|Contact: Sonali Chaudhury, MDemail@example.com|
|Contact: Colleen E Rosen, BS, RNfirstname.lastname@example.org|
|United States, Illinois|
|Ann & Robert H. Lurie Children's Hospital of Chicago||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Sonali Chaudhury, MD 312-227-4863 email@example.com|
|Contact: Colleen E Rosen, BS, RN 312-227-4870 firstname.lastname@example.org|
|Principal Investigator:||Sonali Chaudhury, MD||Ann & Robert H Lurie Children's Hospital of Chicago|