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Immunosuppressant

rATG + Cyclosporine for Aplastic Anemia

Phase 2
Waitlist Available
Led By Jaroslaw Maciejewski
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights

Summary

RATIONALE: Immunosuppressive therapies, such as anti-thymocyte globulin and cyclosporine, may improve bone marrow function and increase blood cell counts. PURPOSE: This phase II trial is studying how well giving anti-thymocyte globulin together with cyclosporine as first-line therapy works in treating patients with severe aplastic anemia.

Eligible Conditions
  • Aplastic Anemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patients Treated With Rabbit Antithymocyte Globulin (r-ATG/Thymoglobulin) and Cyclosporine (CsA) Achieving at Least a Partial Remission (PR) at 6 Months
Secondary outcome measures
Comparison of the Level of IS as Assessed by Immuknow Assay in Responders and Non-responders
Reduction of VB Repertoire Associated With r-ATG/CsA Combination

Trial Design

1Treatment groups
Experimental Treatment
Group I: rATG + CyclosporineExperimental Treatment2 Interventions
Patients receive anti-thymocyte globulin IV daily over 4-24 hours on days 1-5. Beginning on day 6, patients receive oral cyclosporine twice daily for 6 months followed by a taper. Treatment continues in the absence of disease progression or unacceptable toxicity
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antithymocyte immunoglobulin (rabbit)
FDA approved
Cyclosporine
FDA approved

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,045 Previous Clinical Trials
1,370,655 Total Patients Enrolled
1 Trials studying Aplastic Anemia
4 Patients Enrolled for Aplastic Anemia
Jaroslaw MaciejewskiPrincipal InvestigatorCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
~1 spots leftby Sep 2025
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