Alemtuzumab and Rituximab in Aplastic Anemia

Aplastic Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01408342
• Other study ID #: HE11015
• Secondary ID: AA
• Status: Withdrawn
• Phase: N/A
• First received: July 29, 2011
• Last updated: January 3, 2014
• Start date: July 2011
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Aplastic
• Aplastic Anemia

Intervention

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

Locations

Country	Name	City	State
Mexico	Hospital Universitario, Dr. Jose E. Gonzalez	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

References & Publications (6)

Gómez-Almaguer D, Jaime-Pérez JC, Garza-Rodríguez V, Chapa-Rodríguez A, Tarín-Arzaga L, Herrera-Garza JL, Ruiz-Argüelles GJ, López-Otero A, González-Llano O, Rodríguez-Romo L. Subcutaneous alemtuzumab plus cyclosporine for the treatment of aplastic anemia. Ann Hematol. 2010 Mar;89(3):299-303. doi: 10.1007/s00277-009-0816-5. Epub 2009 Aug 25. — View Citation

Gómez-Almaguer D, Solano-Genesta M, Tarín-Arzaga L, Herrera-Garza JL, Cantú-Rodríguez OG, Gutiérrez-Aguirre CH, Jaime-Pérez JC. Low-dose rituximab and alemtuzumab combination therapy for patients with steroid-refractory autoimmune cytopenias. Blood. 2010 Dec 2;116(23):4783-5. doi: 10.1182/blood-2010-06-291831. Epub 2010 Sep 14. — View Citation

Risitano AM, Selleri C, Serio B, Torelli GF, Kulagin A, Maury S, Halter J, Gupta V, Bacigalupo A, Sociè G, Tichelli A, Schrezenmeier H, Marsh J, Passweg J, Rotoli B; Working Party Severe Aplastic Anaemia (WPSAA) of the European Group for Blood and Marrow Transplantation (EBMT). Alemtuzumab is safe and effective as immunosuppressive treatment for aplastic anaemia and single-lineage marrow failure: a pilot study and a survey from the EBMT WPSAA. Br J Haematol. 2010 Mar;148(5):791-6. doi: 10.1111/j.1365-2141.2009.08027.x. Epub 2009 Dec 7. — View Citation

Takamatsu H, Yagasaki H, Takahashi Y, Hama A, Saikawa Y, Yachie A, Koizumi S, Kojima S, Nakao S. Aplastic anemia successfully treated with rituximab: the possible role of aplastic anemia-associated autoantibodies as a marker for response. Eur J Haematol. 2011 Jun;86(6):541-5. doi: 10.1111/j.1600-0609.2011.01612.x. — View Citation

Young NS, Calado RT, Scheinberg P. Current concepts in the pathophysiology and treatment of aplastic anemia. Blood. 2006 Oct 15;108(8):2509-19. Epub 2006 Jun 15. Review. — View Citation

Young NS, Maciejewski J. The pathophysiology of acquired aplastic anemia. N Engl J Med. 1997 May 8;336(19):1365-72. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate efficacy of alemtuzumab and rituximab in aplastic anemia.	Evaluate the hematological response after the administration of alemtuzumab and rituximab	12 months	Yes
Secondary	Measuring the side effects of alemtuzumab and rituximab combination through clinical evaluation		12 months	Yes