NCT01408342

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 7, 2014

Status Verified

January 1, 2014

Enrollment Period

1.5 years

First QC Date

July 29, 2011

Last Update Submit

January 3, 2014

Conditions

Aplastic Anemia

Keywords

AlemtuzumabRituximabAplastic anemiacyclosporine

Outcome Measures

Primary Outcomes (1)

  • Evaluate efficacy of alemtuzumab and rituximab in aplastic anemia.

    Evaluate the hematological response after the administration of alemtuzumab and rituximab

    12 months

Secondary Outcomes (1)

  • Measuring the side effects of alemtuzumab and rituximab combination through clinical evaluation

    12 months

Study Arms (1)

Rituximab, Alemtuzumab

OTHER
Drug: Alemtuzumab and Rituximab

Interventions

Alemtuzumab and RituximabDRUG

* 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

Also known as: Kikuzubam, Mabthera, Mabcampath, Campath
Rituximab, Alemtuzumab

Eligibility Criteria

Age12 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with aplastic anemia diagnosis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario, Dr. Jose E. Gonzalez

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (6)

  • 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.

    PMID: 9134878BACKGROUND

  • 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.

    PMID: 16778145BACKGROUND

  • 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.

    PMID: 19705116BACKGROUND

  • 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.

    PMID: 21418330BACKGROUND

  • 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.

    PMID: 20841509BACKGROUND

  • 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.

    PMID: 19995389BACKGROUND

MeSH Terms

Conditions

Anemia, Aplastic

Interventions

AlemtuzumabRituximab

Condition Hierarchy (Ancestors)

AnemiaHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Failure DisordersBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsAntibodies, Monoclonal, Murine-Derived

Study Officials

  • David Gomez Almaguer, MD

    Hospital Universitario Dr. Jose E. Gonzalez

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 29, 2011

First Posted

August 3, 2011

Study Start

July 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2014

Last Updated

January 7, 2014

Record last verified: 2014-01

Locations

ME(1)