Clinical trial NCT01408342: Alemtuzumab and Rituximab in Aplastic Anemia
Official title: Low-doses Alemtuzumab and Rituximab Combination as First Line Treatment in Aplastic Anemia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Aplastic Anemia
Keywords: Alemtuzumab
Rituximab
Aplastic anemia
cyclosporine
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2011-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Evaluate efficacy of alemtuzumab and rituximab in aplastic anemia.
timeFrame: 12 months
Secondary outcomes:
measure: Measuring the side effects of alemtuzumab and rituximab combination through clinical evaluation
timeFrame: 12 months
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario, Dr. Jose E. Gonzalez
state: Nuevo Leon
Study officials:
affiliation: Hospital Universitario Dr. Jose E. Gonzalez
name: David Gomez Almaguer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Young NS, Maciejewski J. The pathophysiology of acquired aplastic anemia. N Engl J Med. 1997 May 8;336(19):1365-72. doi: 10.1056/NEJM199705083361906. No abstract available.
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. doi: 10.1182/blood-2006-03-010777. Epub 2006 Jun 15.
citation: Gomez-Almaguer D, Jaime-Perez JC, Garza-Rodriguez V, Chapa-Rodriguez A, Tarin-Arzaga L, Herrera-Garza JL, Ruiz-Arguelles GJ, Lopez-Otero A, Gonzalez-Llano O, Rodriguez-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.
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.
citation: Gomez-Almaguer D, Solano-Genesta M, Tarin-Arzaga L, Herrera-Garza JL, Cantu-Rodriguez OG, Gutierrez-Aguirre CH, Jaime-Perez 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.
citation: Risitano AM, Selleri C, Serio B, Torelli GF, Kulagin A, Maury S, Halter J, Gupta V, Bacigalupo A, Socie 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.