Clinical Trials (PDQ®) - National Cancer Institute

Page Options

	Quick Links


	Director's Corner Dictionary of Cancer Terms NCI Drug Dictionary Funding Opportunities NCI Publications Advisory Boards and Groups Science Serving People Español

Questions about cancer?


	1-800-4-CANCER

	LiveHelp® online chat

	NCI Highlights


	Virtual and Standard Colonoscopy Both Accurate Denosumab May Help Prevent Bone Loss Past Highlights

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase IV

Treatment

Completed

Not specified

Other

SMD/ATG-CSA/2002
NCT00488436

Trial Description

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.

Further Study Information

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

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Program for the Study and Treatment of Hematological Malignancies

Sanz Guillermo, Dr

Study Director

Julia Antonio, Dr

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00488436
Information obtained from ClinicalTrials.gov on July 16, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.