Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Rabbit Anti-Thymocyte Globulin (rATG) in the Treatment of Patients With Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
This study is currently recruiting participants.
Verified by Genzyme, December 2007
Sponsored by: Genzyme
Information provided by: Genzyme
ClinicalTrials.gov Identifier: NCT00542828
  Purpose

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

Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
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.

Further study details as provided by Genzyme:

Primary Outcome Measures:
  • Hematological improvement rate. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of hematologic improvement. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Disease remission rate and duration. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Transfusion independence rate and duration. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Relapse rate. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Progression free survival. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Rate of transformation to acute myeloid leukemia. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Cytogenetic response and marrow remission rates. [ Time Frame: 36 months ] [ Designated as safety issue: No ]

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)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed low to intermediate-1 risk MDS.
  • No more than 1 prior treatment for MDS.
  • Exhibit at least one hematological cytopenias (anemia, neutropenia, or thrombocytopenia).
  • Documentation of prior transfusion requirements.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2.
  • Be ≥18 and ≤70 years of age at time of signing the informed consent document (ICD).
  • Is able to adhere to study visit schedule and all other protocol requirements.
  • Is willing to practice a medically approved method of birth control during participation in the study (at least 12 months after the last infusion of rATG) (male and female patients).

Exclusion Criteria:

  • Is pregnant or lactating.
  • Has had prior treatment with any ATG.
  • Has received any immunomodulatory or immunosuppressing agents (excluding steroids) <12 weeks prior to the first infusion of rATG.
  • Has had a prior stem cell and/or other organ transplant.
  • Has had a prior allergic reaction to rabbit proteins or excipients.
  • Has any of the following subtypes of MDS: refractory anemia with ringed sideroblasts (RARS), chronic myelomonocytic leukemia (CMML) if white blood counts > 13x10^9/L or MDS/myeloproliferative diseases (MPD).
  • Has MDS associated with a 5q chromosomal deletion unless patient received prior lenalidomide treatment.
  • Has MDS presumed secondary to exposure to chemicals or treatment with radiotherapy or chemotherapy.
  • Received any treatment with investigational agents, within 4 weeks prior to the first infusion of rATG.
  • Has any of the following abnormalities:a.Serum Creatinine > 1.5 x upper limit of normal (ULN).b.Aspartate transaminase (AST) and alanine transaminase (ALT) > 2.5 x ULN.c. Serum total bilirubin > 1.5 x ULN except for unconjugated hyperbilirubinemia related to the patients's MDS
  • Received any treatment with non-steroidal anti-inflammatory drugs (NSAID)within 14 days prior to the start of treatment.
  • Is known to be human immunodeficiency virus (HIV) positive.
  • Has any prior diagnosis of malignancy other than MDS, unless the patient has been disease-free for at least 5 years following the completion of curative intent therapy.
  • Any serious medical condition (other than MDS) that would limit survival to < 2 years.
  • Active acute or chronic infection, including cytomegaloviremia (CMV), or deep tissue infection.
  • Any other serious medical condition, uncontrolled illness (including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia), social condition, or psychiatric illness that will prevent the patient from signing the informed consent document (ICD), or will place the patient at unacceptable risk if he/she participates in the study, or that would limit compliance with study requirements.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542828

Contacts
Contact: Medical Information 800-745-4447 medinfo@genzyme.com
Contact: Medical Information 617-252-7832 medinfo@genzyme.com

Locations
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            
Sponsors and Collaborators
Genzyme
Investigators
Study Director: Per Lindner, MD Genzyme
  More Information

US FDA Approved Full Prescribing Information for Thymoglobulin®  This link exits the ClinicalTrials.gov site

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)

Study placed in the following topic categories:
Antilymphocyte Serum
Myelodysplastic syndromes
Antibodies
Preleukemia
Precancerous Conditions
Hematologic Diseases
Myelodysplasia
Myelodysplastic Syndromes
Bone Marrow Diseases
Immunoglobulins

Additional relevant MeSH terms:
Neoplasms
Pathologic Processes
Disease
Immunologic Factors
Syndrome
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009