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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00857389 |
Purpose
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.
Objectives:
Primary objective is to determine the safety and efficacy of a pre-transplant conditioning regimen consisting of thiotepa, busulfan, and clofarabine followed by allogeneic hematopoietic stem cell transplant for high risk malignancies.
Secondary objectives are to evaluate the engraftment, toxicity, relapse rate, rate and severity of graft-vs-host disease, disease-free and overall survival.
| Condition | Intervention | Phase |
|---|---|---|
|
Stem Cell Transplantation Leukemia Lymphoma |
Drug: Thiotepa Drug: Clofarabine Drug: Busulfan Procedure: Allogeneic Stem Cell Transplantation Drug: Thymoglobulin (ATG) Drug: G-CSF (Filgrastim) |
Phase II |
| Study Type: | Interventional |
| 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 |
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Drug: Thiotepa
5 mg/kg through a central venous catheter (CVC) over 2 hours on Day -8.
Other Name: Thio
Drug: 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 over 4 hours On Day -3 and -4.
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
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Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00857389 History of Changes |
| Other Study ID Numbers: | 2008-0363 |
| Study First Received: | March 5, 2009 |
| Last Updated: | October 11, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Cancer Blood And Marrow Transplantation Stem Cell Leukemia Lymphoma Pediatrics Bone marrow Lymph node system Allogeneic Stem Cell Transplant ASCT Busulfan Busulfex |
Myleran Clofarabine Clofarex Clolar Thiotepa Antithymocyte globulin ATG Thymoglobulin G-CSF Filgrastim Neupogen |
|
Leukemia Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Antilymphocyte Serum Busulfan Thiotepa Lenograstim |
Clofarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists Adjuvants, Immunologic |