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Alemtuzumab and Rituximab in Aplastic Anemia

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01408342
First Posted: August 3, 2011
Last Update Posted: January 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
  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
Intervention Model: Single Group Assignment
Masking: None (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 David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez:

Primary Outcome Measures:
  • Evaluate efficacy of alemtuzumab and rituximab in aplastic anemia. [ Time Frame: 12 months ]
    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 ]

Enrollment: 0
Study Start Date: July 2011
Study Completion Date: January 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Rituximab, Alemtuzumab 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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01408342


Locations
Mexico
Hospital Universitario, Dr. Jose E. Gonzalez
Monterrey, Nuevo Leon, Mexico, 64460
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
First Submitted: July 29, 2011
First Posted: August 3, 2011
Last Update Posted: January 7, 2014
Last Verified: January 2014

Keywords provided by David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez:
Alemtuzumab
Rituximab
Aplastic anemia
cyclosporine

Additional relevant MeSH terms:
Anemia
Anemia, Aplastic
Hematologic Diseases
Bone Marrow Diseases
Alemtuzumab
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents