Antithymocyte Globulin and Cyclosporine in Treating Low Risk Patients With Myelodysplastic Syndrome

SMD/ATG-CSA: Antithymocyte Globulin and Cyclosporine in Treating Low Risk Patients With Myelodysplastic Syndrome

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00488436

Enrollment

Registered

2007-06-20

Start date

2002-05-31

Completion date

2007-12-31

Last updated

2008-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndrome

Keywords

Myelodysplastic Syndrome, Antithymocyte Globulin, Cyclosporine

Brief summary

The different mechanisms of action between Antithymocyte globulin and cyclosporine can improve the effectivity when both are used in combination in patients with myelodysplastic syndrome.

Detailed description

Patients are treated with: Antithymocyte globulin (Timoglobulin SangStat) * 2,5 mg/kg/day IV over 8 hours on days 1-4 * Total dose: 10 mg/kg * Calculated dose adjusted to ideal weight * Especial considerations: Paracetamol 1 gr (oral or IV) Dexclorfeniramine 5 mg IV Methylprednisolone 1 mg/kg IV 30 minutes before Timoglobulin and repeat if necessary at 4 hours - Platelet transfusion if platelet count is \< 50 x 109/L Cyclosporine (Sandimmun Neoral) -2,5 mg/kg/12 h over 3 months

Interventions

DRUGAntithymocyte globulin

DRUGCyclosporine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Diagnosis of low or intermediate risk myelodysplastic syndrome (MDS) (or high risk patient not eligible to intensive chemotherapy or for bone marrow transplantation), excluding chronic myelomonocytic leukemia * At less one of two following conditions: * Transfusion dependence: 1)Packed red blood cell transfusions greater than 2 times; 2)Untransfused hemoglobin level no greater than 10 g/dL; 3)Platelet transfusions greater than 1 time * Infection grade III or IV secondary to neutropenia * ECOG \< or = 2

Exclusion criteria

* Chronic myelomonocytic leukemia * Creatinine greater than 2 mg/dl * Bilirubin greater than 2.5 mg/dl * History of heart failure * History of allergy to rabbit proteins

Design outcomes

Primary

Measure	Time frame
Compare the efficacy and toxicity of antithymocyte globulin and cyclosporine in patients with low risk myelodysplastic syndrome	3 years

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026