Know Cancer

or
forgot password

Low Doses of Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias


Phase 2/Phase 3
16 Years
N/A
Not Enrolling
Both
Idiopathic Thrombocytopenic Purpura, Anemia, Hemolytic, Autoimmune

Thank you

Trial Information

Low Doses of Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias


Autoimmune cytopenias are a common entities with good responses to steroids therapies as
first line, but there is a considerable percentage of patients who relapse, become
refractory or dependant on steroids to maintain an acceptable level of hemoglobin or
platelets, and the treatment becomes more difficult increasing the secondary effects. The
current study evaluates the safety and efficacy of the combination of low doses of
alemtuzumab (anti CD52) and Rituximab (anti CD 20) as a second line treatment option for
this subset of patients improving the cytopenias without increasing the adverse effects.


Inclusion Criteria:



- Age: > or = 16 years

- Weight: more than 40 Kg

- Autoimmune Hemolytic anemia with clinical and biochemical evidence of hemolysis
refractory to treatment, in relapse or steroids dependant

- Idiopathic thrombocytopenic purpura with platelet counts < 50,000, refractory to
treatment, in relapse or steroids dependant

Exclusion Criteria:

- Current viral or bacterial infection.

- Positive serology for HIV, HCV, HBV.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective response rate (CR: complete remission, PR: partial remission, relapse rate.

Outcome Time Frame:

1, 2, 4 and 6 months

Safety Issue:

Yes

Principal Investigator

David Gomez-Almaguer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Universitario Dr. Jose E. Gonzalez

Authority:

Mexico: Ethics Committee

Study ID:

HE08-004

NCT ID:

NCT00749112

Start Date:

August 2008

Completion Date:

August 2010

Related Keywords:

  • Idiopathic Thrombocytopenic Purpura
  • Anemia, Hemolytic, Autoimmune
  • Idiopathic Thrombocytopenic Purpura
  • Anemia
  • Hemolytic
  • Autoimmune
  • Alemtuzumab
  • Rituximab
  • Anemia
  • Anemia, Hemolytic
  • Anemia, Hemolytic, Autoimmune
  • Purpura
  • Purpura, Thrombocytopenic
  • Purpura, Thrombocytopenic, Idiopathic
  • Hemolysis

Name

Location