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Alemtuzumab and Rituximab in Aplastic Anemia

Primary Purpose

Aplastic Anemia

Status
Withdrawn
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Alemtuzumab and Rituximab
Sponsored by
Hospital Universitario Dr. Jose E. Gonzalez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aplastic Anemia focused on measuring Alemtuzumab, Rituximab, Aplastic anemia, cyclosporine

Eligibility Criteria

12 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario, Dr. Jose E. Gonzalez

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Rituximab, Alemtuzumab

Arm Description

Outcomes

Primary Outcome Measures

Evaluate efficacy of alemtuzumab and rituximab in aplastic anemia.
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

Full Information

First Posted
July 29, 2011
Last Updated
January 3, 2014
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
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1. Study Identification

Unique Protocol Identification Number
NCT01408342
Brief Title
Alemtuzumab and Rituximab in Aplastic Anemia
Official Title
Low-doses Alemtuzumab and Rituximab Combination as First Line Treatment in Aplastic Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Withdrawn
Study Start Date
July 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Dr. Jose E. Gonzalez

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aplastic Anemia
Keywords
Alemtuzumab, Rituximab, Aplastic anemia, cyclosporine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rituximab, Alemtuzumab
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Alemtuzumab and Rituximab
Other Intervention Name(s)
Kikuzubam, Mabthera, Mabcampath, Campath
Intervention Description
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
Primary Outcome Measure Information:
Title
Evaluate efficacy of alemtuzumab and rituximab in aplastic anemia.
Description
Evaluate the hematological response after the administration of alemtuzumab and rituximab
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Measuring the side effects of alemtuzumab and rituximab combination through clinical evaluation
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Gomez Almaguer, MD
Organizational Affiliation
Hospital Universitario Dr. Jose E. Gonzalez
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario, Dr. Jose E. Gonzalez
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
9134878
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.
Results Reference
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PubMed Identifier
16778145
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.
Results Reference
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PubMed Identifier
19705116
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.
Results Reference
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PubMed Identifier
21418330
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.
Results Reference
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PubMed Identifier
20841509
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.
Results Reference
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PubMed Identifier
19995389
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.
Results Reference
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Alemtuzumab and Rituximab in Aplastic Anemia

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