Thiotepa-Clofarabine-Busulfan With Allogeneic Stem Cell Transplant for High Risk Malignancies
|Stem Cell Transplantation Leukemia Lymphoma||Drug: Thiotepa Drug: Clofarabine Drug: Busulfan Procedure: Allogeneic Stem Cell Transplantation Drug: Thymoglobulin (ATG) Drug: G-CSF (Filgrastim) Drug: Tacrolimus Drug: Methotrexate Drug: Cyclophosphamide Drug: Mesna||Phase 2|
|Study Design:||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 ]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 2018 (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
Post haploidentical stem cell transplant participants:
Cyclophosphamide 50 mg/kg by vein on Days + 3 and + 4. Mesna 10 mg/kg by vein just prior to the first dose of cyclophosphamide, repeated every 4 hours for a total of ten (10) doses.
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 5,000 µMol-min 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: NeupogenDrug: Tacrolimus
Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily, to be changed to oral dosing when tolerated. Tacrolimus is to be tapered as indicated after transplant day 90, if no GVHD is present. Tacrolimus is adjusted trough level of 5-15 ng/mL.
Other Name: PrografDrug: Methotrexate
5 mg/m2 by vein on Days 1, 3 and 6 and Day +11 post transplant. The Day 11 methotrexate dose may be held as indicated if mucositis is present.Drug: Cyclophosphamide
Post haploidentical stem cell transplant participants: 50 mg/kg by vein on Days + 3 and + 4.
Other Names:Drug: Mesna
Post haploidentical stem cell transplant participants: 10 mg/kg by vein just prior to the first dose of cyclophosphamide, repeated every 4 hours for a total of ten (10) doses.
Other Name: Mesnex
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857389
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Laura L. Worth, MD, PhD||M.D. Anderson Cancer Center|