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Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias

Primary Purpose

Idiopathic Thrombocytopenic Purpura, Anemia, Hemolytic, Autoimmune

Status

Completed

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

Alemtuzumab, Rituximab

About this trial

This is an interventional treatment trial for Idiopathic Thrombocytopenic Purpura focused on measuring Idiopathic Thrombocytopenic Purpura, Anemia, Hemolytic, Autoimmune, Alemtuzumab, Rituximab

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00749112

First Posted

September 8, 2008

Last Updated

August 27, 2010

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

1. Study Identification

Unique Protocol Identification Number

NCT00749112

Brief Title

Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine whether the combination of low doses of alemtuzumab and rituximab are effective in the treatment of patients with autoimmune cytopenias who has failed on steroids, relapsed after steroids withdrawal or required continuous steroids treatment.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Thrombocytopenic Purpura, Anemia, Hemolytic, Autoimmune

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Alemtuzumab, Rituximab

Other Intervention Name(s)

campath, mabthera

Intervention Description

Alemtuzumab 10 mg each 24 hrs subcutaneous for 3 days. Rituximab 100 mg IV every week for 4 weeks.

Primary Outcome Measure Information:

Title

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

Time Frame

1, 2, 4 and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

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

Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64460

Country

Mexico

12. IPD Sharing Statement

Citations:

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

derived

Learn more about this trial

Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias

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