Alemtuzumab and Rituximab in Aplastic Anemia

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez Identifier:
First received: July 29, 2011
Last updated: January 3, 2014
Last verified: January 2014
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 ]

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


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

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
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Please refer to this study by its identifier: NCT01408342

Hospital Universitario, Dr. Jose E. Gonzalez
Monterrey, Nuevo Leon, Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Principal Investigator: David Gomez Almaguer, MD Hospital Universitario Dr. Jose E. Gonzalez
  More Information


Responsible Party: David Gomez Almaguer, MD, Hospital Universitario Dr. Jose E. Gonzalez Identifier: NCT01408342     History of Changes
Other Study ID Numbers: HE11015, AA
Study First Received: July 29, 2011
Last Updated: January 3, 2014
Health Authority: Mexico: Ministry of Health

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

Additional relevant MeSH terms:
Anemia, Aplastic
Bone Marrow Diseases
Hematologic Diseases
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 25, 2015