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Thymoglobulin and Cyclosporine in Patients With Aplastic Anemia or Myelodysplastic Syndrome

NCT00806598 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2013-03-12

Study results available
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Summary

The goal of this clinical research study is to learn if combining the drugs thymoglobulin, methylprednisolone, cyclosporine, and G-CSF (NeupogenTM or NeulastaTM ) can help to control severe aplastic anemia (AA) or hypoplastic myelodysplastic syndrome (MDS). The safety of this combination therapy will also be studied.

Conditions

Interventions

DRUG

Thymoglobulin

3.5 or 2.5 mg/kg/day IV for 5 days * Aplastic anemia patients receive 3.5 mg/kg/day for 5 days * MDS patients \<55 years receive 3.5 mg/kg/day for 5 days * MDS patients \>55 years receive 2.5 mg/kg/day for 5 days

DRUG

Cyclosporine

5 mg/kg orally for 6 months; start after completing thymoglobulin.

DRUG

Methylprednisolone

1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin.

DRUG

G-CSF

5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Tapan M. Kadia, M.D. · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00806598 on ClinicalTrials.gov