Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
M.D. Anderson Cancer Center |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00427791 |
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 |
Estimated Enrollment: | 80 |
Study Start Date: | July 2005 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Etoposide + Total Body Irradiation + Rituximab
|
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
|
2: Experimental
Etoposide + Total Body Irradiation
|
Drug: Etoposide
60 mg/kg IV Daily Over 4 Hours x 1 Day
Radiation: Total Body Irradiation
3 Gy Daily x 4 Days
|
Ages Eligible for Study: | up to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00427791 |
Health Authority: | United States: Institutional Review Board |
Acute Lymphoblastic Leukemia Leukemia Total Body Irradiation Etoposide |
Rituximab Rituxan TBI ALL |
Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma |
Rituximab Lymphoproliferative Disorders Etoposide phosphate Etoposide Lymphoma |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |