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Low-doses Alemtuzumab and Rituximab Combination as First Line Treatment in Aplastic Anemia


N/A
12 Months
N/A
Open (Enrolling)
Both
Aplastic Anemia

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Trial Information

Low-doses Alemtuzumab and Rituximab Combination as First Line Treatment in Aplastic Anemia


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate efficacy of alemtuzumab and rituximab in aplastic anemia.

Outcome Description:

Evaluate the hematological response after the administration of alemtuzumab and rituximab

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

David Gomez Almaguer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Universitario Dr. Jose E. Gonzalez

Authority:

Mexico: Ministry of Health

Study ID:

HE11015

NCT ID:

NCT01408342

Start Date:

July 2011

Completion Date:

July 2014

Related Keywords:

  • Aplastic Anemia
  • Alemtuzumab
  • Rituximab
  • Aplastic anemia
  • cyclosporine
  • Anemia
  • Anemia, Aplastic

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