Thiotepa-Clofarabine-Busulfan With Allogeneic Stem Cell Transplant for High Risk Malignancies
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|ClinicalTrials.gov Identifier: NCT00857389|
Recruitment Status : Active, not recruiting
First Posted : March 6, 2009
Last Update Posted : April 18, 2018
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.
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.
This is an investigational study. Thiotepa and clofarabine are FDA approved and commercially available for the treatment of leukemia. Busulfan is FDA approved and commercially available for use in stem cell transplantation. The combination of thiotepa, clofarabine, and busulfan together with a stem cell transplant is investigational.
Up to 60 participants will take part in this study. All will be enrolled at M. D. Anderson.
|Condition or disease||Intervention/treatment||Phase|
|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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Thiotepa-Clofarabine-Busulfan With Allogeneic Stem Cell Transplant for High Risk Malignancies|
|Actual Study Start Date :||March 2009|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
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: Thio
40 mg/m^2 through a central venous catheter (CVC) over 1 hour daily on 4 consecutive days (Days -6 through -3).
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.
Procedure: Allogeneic Stem Cell Transplantation
Infusion of stem cells through through a central venous catheter (CVC) On Day 0.
Drug: Thymoglobulin (ATG)
1.25 mg/kg by vein on Day -4 and 1.75 mg/kg on Day -3.
Other Name: Antithymocyte globulin
Drug: 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
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: Prograf
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.
Post haploidentical stem cell transplant participants: 50 mg/kg by vein on Days + 3 and + 4.
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
- 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.
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): NCT00857389
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Kris M. Mahadeo, MD||M.D. Anderson Cancer Center|