Alemtuzumab and Rituximab in Aplastic Anemia

Alemtuzumab and Rituximab in Aplastic Anemia
This study is currently recruiting participants.
Verified July 2011 by Hospital Universitario Dr. Jose E. Gonzalez

First Received on July 29, 2011.  
Last Updated on August 2, 2011  
History of Changes
Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Information provided by: Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT01408342
  Purpose

The purpose of the study is to evaluate the efficacy of combination of alemtuzumab and rituximab as first line therapy in aplastic anemia.

Condition Intervention
Aplastic Anemia Drug: Alemtuzumab and Rituximab

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Low-doses Alemtuzumab and Rituximab Combination as First Line Treatment in Aplastic Anemia

Resource links provided by NLM:

Further study details as provided by Hospital Universitario Dr. Jose E. Gonzalez:

Primary Outcome Measures:

  • Evaluate efficacy of alemtuzumab and rituximab in aplastic anemia. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Evaluate the hematological response after the administration of alemtuzumab and rituximab

Secondary Outcome Measures:

  • Measuring the side effects of alemtuzumab and rituximab combination through clinical evaluation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: July 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:

    Drug: Alemtuzumab and Rituximab

    • Alemtuzumab 10 mg (5 mg/m2 in patients under 30 kg weight) subcutaneous days 1,2 and 3
    • Rituximab 100 mg (50 mg/m2 in patients under 30 kg weight)intravenous days 4,11,18,25
    • Cyclosporine 3 mg/kg starting day 21
    Other Names:
    • Kikuzubam
    • Mabthera
    • Mabcampath
    • Campath

  Eligibility

Ages Eligible for Study:   12 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with aplastic anemia diagnosis

Exclusion Criteria:

  • Patients with prior treatment with monoclonal antibodies and/or antithymocyte globulin.
  • Patients with a diagnosis or history of HIV/AIDS, Hepatitis B, Hepatitis C, Cytomegalovirus.
  • Patients who do not agree to sign a Letter of Informed Consent.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408342

Locations
Mexico
Hospital Universitario, Dr. Jose E. Gonzalez Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Contact: David Gomez Almaguer, MD     +5283486136 ext 411     dr_gomez@infosel.net.mx    
Contact: Roxana Saldaña Vázquez, MD     +5283486136 ext 331     rocxz@hotmail.com    
Principal Investigator: David Gomez Almaguer, MD            
Sub-Investigator: Roxana Saldaña Vázquez, MD            
Sub-Investigator: Juan A Flores Jiménez, MD            
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
Principal Investigator: David Gomez Almaguer, MD Hospital Universitario Dr. Jose E. Gonzalez
  More Information

Publications:

Responsible Party: David Gomez Almaguer MD, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT01408342    
History of Changes
Other Study ID Numbers: HE11015, AA
Study First Received: July 29, 2011
Last Updated: August 2, 2011
Health Authority: Mexico: Ministry of Health

Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:

Alemtuzumab
Rituximab
Apalstic anemia
cyclosporine

Additional relevant MeSH terms:

Anemia
Anemia, Aplastic
Hematologic Diseases
Bone Marrow Diseases
Alemtuzumab
Rituximab
Campath 1G
Antibodies, Neoplasm
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 21, 2012

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