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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00427791 |
Purpose
Primary Objective:
Secondary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: Etoposide Radiation: Total Body Irradiation Drug: Rituximab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase II Randomized Study Evaluating the Addition of Rituximab to the Preparative Regimen of Etoposide and Total Body Irradiation in Acute Lymphoblastic Leukemia |
| Enrollment: | 23 |
| Study Start Date: | July 2005 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Etoposide + Total Body Irradiation + Rituximab: Experimental |
Drug: Etoposide
60 mg/kg IV Daily Over 4 Hours x 1 Day
Radiation: Total Body Irradiation
3 Gy Daily x 4 Days
Drug: Rituximab
375 mg/m^2 IV Weekly Over 4-8 Hours x 4 Weeks
|
| Etoposide + Total Body Irradiation: Experimental |
Drug: Etoposide
60 mg/kg IV Daily Over 4 Hours x 1 Day
Radiation: Total Body Irradiation
3 Gy Daily x 4 Days
|
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| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Partow Kebriaei, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Partow Kebriaei, MD/Assistant Professor ) |
| Study ID Numbers: | 2004-0989 |
| Study First Received: | January 25, 2007 |
| Last Updated: | October 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00427791 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Acute Lymphoblastic Leukemia Leukemia Total Body Irradiation Etoposide |
Rituximab Rituxan TBI ALL |
|
Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Antineoplastic Agents Rituximab Physiological Effects of Drugs Etoposide phosphate |
Pharmacologic Actions Leukemia Lymphatic Diseases Neoplasms Therapeutic Uses Antirheumatic Agents Lymphoproliferative Disorders Etoposide Antineoplastic Agents, Phytogenic |