Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Genzyme |
---|---|
Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00542828 |
This is a Phase II, single-arm, open-label, multinational, multicenter study of rATG in patients with low or intermediate-1 risk MDS who have either failed 1 prior treatment with growth factor(s), hypomethylating agents (5-azacitidine or decitabine), or the antiangiogenic agents lenalidomide or thalidomide, or who have never been treated for MDS (i.e. treatment naïve patients).
Condition | Intervention | Phase |
---|---|---|
Myelodysplastic Syndrome (MDS) |
Biological: Thymoglobulin®, Rabbit Anti-thymocyte Globulin (rATG) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study of the Efficacy of Rabbit Anti-Thymocytes Globulin (rATG) in Patients With Low and Intermediate-1 Risk Myelodysplastic Syndrome. |
Estimated Enrollment: | 43 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Thymoglobulin: Experimental |
Biological: Thymoglobulin®, Rabbit Anti-thymocyte Globulin (rATG)
All patients will be treated with rATG 3.75 mg/kg/day administered by IV infusion over ≥ 6 hours, for 5 consecutive days (cumulative dose: 18.75 mg/kg)
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Medical Information | 800-745-4447 | medinfo@genzyme.com |
Contact: Medical Information | 617-252-7832 | medinfo@genzyme.com |
United States, Illinois | |
RUSH University Medical Center | Recruiting |
Chicago, Illinois, United States | |
Principal Investigator: Jamile Shammo | |
United States, Virginia | |
Virginia Commonwealth University | Recruiting |
Richmond, Virginia, United States | |
Principal Investigator: John McCarty | |
United States, Washington | |
Fred Hutchinson Cancer Research Center (FHCRC) | Recruiting |
Seattle, Washington, United States | |
Principal Investigator: Bart Scott, MD | |
France | |
Hopital Avicenne/University | Recruiting |
Paris, France | |
Principal Investigator: Pierre Fenaux | |
Hopital Huriev | Recruiting |
Lille, France | |
Principal Investigator: Bruno Quesnel | |
Germany | |
Medizinische Hochschule Hannover | Recruiting |
Hannover, Germany | |
Principal Investigator: Arnold Ganser | |
St. Johannes-Hospital Duisburg | Recruiting |
Duisburg, Germany | |
Principal Investigator: Aristoteles Giagounidis | |
Netherlands | |
UMC St Radboud Centraal | Recruiting |
Nijmegen, Netherlands | |
Principal Investigator: Petra Muus | |
United Kingdom | |
St James Hospital | Recruiting |
Leeds, United Kingdom | |
Principal Investigator: David Bowen | |
United Kingdom, England | |
King's College Hospital | Recruiting |
London, England, United Kingdom, SE5 9RS | |
Principal Investigator: Ghulam J. Mufti, MD | |
Royal Bournemouth Hospital | Recruiting |
Bournemouth, England, United Kingdom | |
Principal Investigator: Sally Killick |
Study Director: | Per Lindner, MD | Genzyme |
Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
Study ID Numbers: | ThymoHEMO1206 |
Study First Received: | October 10, 2007 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00542828 |
Health Authority: | United States: Food and Drug Administration; Germany: Paul-Ehrlich-Institut (PEI); United Kingdom: Medicines and Healthcare Products Regulatory Agency; France: French Regulatory Authority (AFSSAPS); European Union: European Medicines Agency (EMEA); Netherlands: Netherlands Regulatory Agency (CBG) |
Antilymphocyte Serum Myelodysplastic syndromes Antibodies Preleukemia Precancerous Conditions |
Hematologic Diseases Myelodysplasia Myelodysplastic Syndromes Bone Marrow Diseases Immunoglobulins |
Neoplasms Pathologic Processes Disease Immunologic Factors |
Syndrome Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |