Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Alemtuzumab to Treat Severe Aplastic Anemia

Lead Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Severe Aplastic Anemia, Refractory

Severe Aplastic Anemia, Relapse

Eligibility:

All Genders

2-110 years

Phase:

PHASE2

Brief Summary

This study will evaluate the safety and usefulness of a new immunosuppressive drug, alemtuzumab (Campath ), in patients with severe aplastic anemia (SAA). SAA is a rare and serious blood disorder in w...

Detailed Description

Hematopoietic stem cell destruction in many human bone marrow failure syndromes is now recognized to be secondary to immune mechanisms. Severe aplastic anemia (SAA) is a life-threatening blood disease...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Relapsed severe aplastic anemia after initial hematologic response to a prior course of h-ATG or r-ATG based immunosuppression
  • Or
  • Refractory severe aplastic anemia not responding to both horse-ATG and rabbit ATG-based immunosuppression
  • The criteria for severe aplastic anemia are two of the three criteria:
  • Absolute neutrophil count less than or equal to 500 /mm(3)
  • Platelets to less than or equal to 20,000/mm(3)
  • Absolute reticulocyte count less than 60,000 /microL
  • Age greater than or equal to 2 years old and greater than 12 kg
  • Prospective subjects or their parent(s)/responsible guardian(s) must be able to comprehend and be willing to sign an informed consent.
  • EXCLUSION CRITERIA:
  • Known Diagnosis of Fanconi's anemia
  • Evidence of a clonal disorder on cytogenetics. In the refractory disease setting, prospective subjects with super severe neutropenia (ANC less than 200 /microL) will not be excluded if results of cytogenetics are not available or pending.
  • Infection not adequately responding to appropriate therapy
  • HIV positivity
  • Failure to discontinue the herbal supplements Echinacea purpurea or Usnea barbata (Old Man's Beard) within 2 weeks of enrollment
  • Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious, or metabolic disease of such severity that it would preclude the patient's ability to tolerate protocol therapy, or that death within 7-10 days is likely
  • Previous hypersensitivity to alemtuzumab or its components
  • Potential subjects with cancer who are on active chemotherapeutic treatment or who take drugs with hematological effects will not be eligible
  • Current pregnancy, or unwilling to take oral contraceptives or refrain from pregnancy if of childbearing potential
  • Not able to understand the investigational nature of the study or give informed consent

Exclusion

    Key Trial Info

    Start Date :

    September 15 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 15 2018

    Estimated Enrollment :

    47 Patients enrolled

    Trial Details

    Trial ID

    NCT00195624

    Start Date

    September 15 2005

    End Date

    October 15 2018

    Last Update

    July 7 2020

    Active Locations (1)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (1 locations)

    1

    National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States, 20892