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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00402558 |
Purpose
The primary objectives are the following:
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndrome Leukemia |
Drug: Thymoglobulin Drug: Busulfan Drug: Fludarabine |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Alloreactive NK Cells With Busulfan, Fludarabine and Thymoglobulin for Allogeneic Stem Cell Transplantation for AML and MDS |
| Estimated Enrollment: | 18 |
| Study Start Date: | May 2006 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Thymoglobulin + Busulfan + Fludarabine: Experimental |
Drug: Thymoglobulin
1.5 mg/kg By Vein Daily x 3 Days
Drug: Busulfan
130 mg/m^2 By Vein Over 3 Hours x 4 Days
Drug: Fludarabine
40 mg/m^2 By Vein Over 30 Minutes x 4 Days
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Richard E. Champlin, MD | 713-792-8750 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Richard E. Champlin, MD | |
| Principal Investigator: | Richard E. Champlin, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Richard E. Champlin, MD/Professor ) |
| Study ID Numbers: | 2005-0508 |
| Study First Received: | November 20, 2006 |
| Last Updated: | July 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00402558 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Acute Myeloid Leukemia Chronic Myelogenous Leukemia Myelodysplastic Syndrome Leukemia NK Cells Natural Killer Cells Fludarabine Busulfan Thymoglobulin |
AML CML MDS ATG Antithymocyte globulin Busulfex Myleran® Fludarabine Phosphate |
|
Antimetabolites Anti-Infective Agents Vidarabine Antimetabolites, Antineoplastic Precancerous Conditions Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leukemia Preleukemia Pathologic Processes Syndrome Therapeutic Uses Alkylating Agents |
Disease Neoplasms by Histologic Type Hematologic Diseases Myelodysplastic Syndromes Fludarabine monophosphate Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Antilymphocyte Serum Neoplasms Busulfan Myeloablative Agonists Fludarabine Antineoplastic Agents, Alkylating Bone Marrow Diseases |