Thiotepa-Clofarabine-Busulfan With Allogeneic Stem Cell Transplant for High Risk Malignancies
The goal of this clinical research study is to learn if thiotepa, busulfan, and clofarabine, when given before an allogeneic (bone marrow , blood, or cord blood cells) or haploidentical (bone marrow) stem cell transplantation can help to control cancers of the bone marrow and lymph node system. The safety of this treatment will also be studied.
Stem Cell Transplantation
Procedure: Allogeneic Stem Cell Transplantation
Drug: Thymoglobulin (ATG)
Drug: G-CSF (Filgrastim)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Thiotepa-Clofarabine-Busulfan With Allogeneic Stem Cell Transplant for High Risk Malignancies|
- Relapse-free Survival Rate [ Time Frame: 100 days post-transplant ] [ Designated as safety issue: No ]Number of participants out of total participants without detection of histologic diagnosis of recurrent disease on day 100 following stem cell transplant.
|Study Start Date:||March 2009|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Thio-Clo-Bu with Allo SCT
Pre-transplant conditioning regimen:
Thiotepa (Thio) + Clofarabine (Clo) + Busulfan (Blu) + Allogeneic Stem Cell Transplantation (Allo SCT) + ATG + G-CSF
5 mg/kg through a central venous catheter (CVC) over 2 hours on Day -8.
Other Name: ThioDrug: Clofarabine
40 mg/m^2 through a central venous catheter (CVC) over 1 hour daily on 4 consecutive days (Days -6 through -3).
Other Names:Drug: Busulfan
Test dose of 0.5 mg/kg through a central venous catheter (CVC)over 30 minutes on Day -7.
High dose through a central venous catheter (CVC) over 3 hours on Days -5, -4, and -3.
Other Names:Procedure: Allogeneic Stem Cell Transplantation
Infusion of stem cells through through a central venous catheter (CVC) On Day 0.
Other Names:Drug: Thymoglobulin (ATG)
1.25 mg/kg by vein on Day -4 and 1.75 mg/kg on Day -3.
Other Name: Antithymocyte globulinDrug: G-CSF (Filgrastim)
5 µg/kg Injection under the skin once a day, starting 1 week after transplant, until blood cell levels return to normal.
Other Name: Neupogen
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|Contact: Laura L. Worth, MD, PhD||713-792-6620|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Laura L. Worth, MD, PhD|
|Principal Investigator:||Laura L. Worth, MD, PhD||UT MD Anderson Cancer Center|