Alemtuzumab and Rituximab in Aplastic Anemia

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT01408342
First received: July 29, 2011
Last updated: January 3, 2014
Last verified: January 2014
  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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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:
Alemtuzumab
Rituximab
Aplastic 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 July 29, 2014