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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Bayer |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00071396 |
Purpose
The goal of this clinical research study is to learn if giving CAMPATH-1H with rituximab can shrink or slow the growth of the disease in patients with chronic lymphoid disorders that have either not responded or whose disease has returned after treatment with standard therapies.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia |
Drug: Campath-1H Drug: Rituximab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Continuous Infusion Followed by Subcutaneous Injection of Campath-1H Plus Rituximab in the Treatment of CD52- and CD20-Positive Refractory or Relapsed Chronic Lymphoid Disorders |
| Enrollment: | 48 |
| Study Start Date: | October 2002 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Campath-1H + Rituximab: Experimental |
Drug: Campath-1H
15 mg/day Continuous infusion by vein for 6 days then given twice a week for remaining three weeks as 30 mg injection under skin to complete one treatment course of 4 weeks.
Drug: Rituximab
375 mg/m^2 IV infusion on day 1, then 500mg/m^2 on days 8, 15, and 22.
|
Objectives:
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Alessandra Ferrajoli, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | UT MD Anderson Cancer Center ( Alessandra Ferrajoli, MD, BS / Assistant Professor ) |
| Study ID Numbers: | ID02-368 |
| Study First Received: | October 21, 2003 |
| Last Updated: | July 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00071396 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Chronic Lymphocytic Leukemia CD-52 and CD-20 Positive Refractory Relapsed |
|
Leukemia, Lymphoid Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Physiological Effects of Drugs Pharmacologic Actions |
Leukemia Lymphatic Diseases Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Alemtuzumab Antirheumatic Agents Leukemia, B-Cell Lymphoproliferative Disorders |